Strategic Account Manager - Vaccines - Washington, D.C./ Maryland (Remote)
Washington, DC jobs
Job Title: Strategic Account Manager- Vaccines About the Job The Strategic Account Management organization is a highly skilled forward-thinking sales team serving our largest and most complex customers, while also managing our highest valued vaccine contracts. The customers we call on primarily include Health Systems, IHNs, Medical Groups, PBGs, FQHCs and state Awardees.
We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
* Assume the leadership role within assigned accounts, providing overall account leadership to cross-functional internal and external team members as needed. In this capacity, the SAM will assume responsibility for assigned strategic customers and manage each as a business partnership on behalf of Sanofi. Additionally, the SAM will bear full responsibility for building a strategic account plan for assigned accounts, as well as organizing and deploying the appropriate resources within Sanofi to drive value co-creation with customers and meet/exceed Sanofi's revenue targets.
* Effectively manage and grow a network of trust-based relationships with external stakeholders to generate revenue through genuine partnerships within Sanofi's largest and most complex customers. The SAM will develop a deep understanding of the customer's business which includes their pressures and drivers, priorities, as well as their related challenges and opportunities. They will maintain working knowledge of the customer's business model, strategic goals and objectives, and their position within the healthcare environment including value-based health care, their competitors, and financial levers.
* Identify and qualify high value opportunities within their accounts by working directly with the customer to develop and drive growth strategies, team-to-team alignment, and executive relationships together with internal cross-functional team members. Accordingly, the SAM will conduct business coaching and strategy session with their account teams to facilitate the co-creation of customer value and ensure ongoing internal alignment and account growth. The SAM will function as the central focal point for communications regarding account planning, strategy, collaboration, resource allocation and customer engagement.
About You
Basic Qualifications
Minimum required skills & experience:
* Bachelor's degree required
* 5+ years of field sales or account management experience
* Internal candidates with a consistent history of performance along with demonstrated capabilities or competencies may be considered with less experience.
* Broad understanding of health system business, decision making processes & market trends with a proven track record of accessing C-suite to D-suite decision makers
* Proven ability to translate health system market knowledge and develop strategic plans with internal stakeholders
* The ability to execute tactical initiatives, provide ongoing feedback, and prioritize multiple projects.
* Broad field sales experience with demonstrated success working with P&T committees, decision makers & influencers in Hospitals, Health Systems, IHNs and other large-organized customers
* Possesses strong business acumen and strategic thinking skills
* Self-directed and organized with excellent execution and planning skills
* Ability to adapt and change in a shifting environment
* Excellent communication skills both written and oral
* Must possess valid driver's license, be eligible for insurance coverage and must be able to safely operate a vehicle
Minimum preferred skills & experience:
* MBA or other advanced degree
* Strong data analytics
* Experience working in Market Access, Pricing, Contracting or Finance
* Proficient with MS Office and customer management databases
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or a lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs, and at least 14 weeks' gender-neutral parental leave.
This position is eligible for a company car through the Company's FLEET program.
Candidates must complete all fleet safety training and must maintain an acceptable driving record regarding accidents and incidents.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Remote
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$122,250.00 - $203,750.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplyHSE & Operational excellence manager
Pearl River, NY jobs
Job title: HSE & Operational excellence manager
% Remote working and % of travel expected:
100% on-site, < 5% travel expected
About the job
The SMS Lead- HSE Champion is responsible for leading Health, Safety, and Environmental (HSE) initiatives and supporting Manufacturing Excellence (ME) programs within Pearl River operations. This role ensures compliance with regulatory and internal standards, drives continuous improvement, and fosters a culture of safety and operational excellence across all levels of the organization.
We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.
Main responsibilities
HSE Champion Responsibilities:
HSE Communications & Culture:
Cascade monthly HSE updates, KPIs, audit results, and program changes.
Share best practices and lessons learned across departments.
Support site programs in industrial hygiene, biosafety, fire and life safety, occupational safety, process safety, and environmental compliance.
Attend and contribute to monthly HSE meetings.
Safety Program Management:
Maintain and update JHAs and annual risk maps.
Coordinate product stewardship activities (e.g., SDS updates, chemical inventory).
Ensure compliance with medical surveillance and task-based risk assessments.
Support regulatory compliance activities (e.g., hazardous waste management, spill response, ASTs, energy control/LOTO, contractor safety).
Incident & Compliance Management:
Initiate and manage accident investigations in Qualipso.
Own and track action plans and link incidents to risk profiles.
Conduct internal audits and inspections; ensure compliance with regulatory standards (e.g., hazardous waste, ASTs, KSEs).
Initiate and manage accident/incident investigations in Qualipso, ensuring timely root cause analysis and corrective/preventive actions (CAPAs).
Shop Floor Engagement
Lead Gemba walks and MSV (Managing for Safety & Value) schedules.
Support coactivity planning, permit-to-work processes, and emergency drills (fire, spill, MERT, biohazard).
Deliver onboarding training for non-GMP areas.
Maintain and update safety maps and visual management tools.
Escalation & Continuous Improvement:
Act as a liaison between area managers, HSE, and maintenance for escalations.
Identify and escalate improvement ideas.
Monitor and trend safety and performance data (e.g., SRR, MSV, injuries, incidents).
Operational Excellence Responsibilities:
Continuous Improvement & Culture Building
Support site-wide continuous improvement initiatives using structured tools, templates, and internal communications.
Lead proactive learning activities such as After Action Reviews, cross-functional workshops, and kaizen events.
Promote a culture of operational excellence and employee engagement.
KPI Management & Performance Tracking:
Manage operational KPIs (e.g., +QDCI) and facilitate cascaded reviews from shop floor to senior leadership.
Ensure alignment of performance metrics with site goals and strategic priorities.
Data Analytics & Visualization:
Ensure data quality and integrity for global performance dashboards and reporting systems.
Utilize tools such as Power BI and iObeya to visualize trends and support decision-making.
About You
Education:
Bachelor's degree in Occupational Health and Safety, Engineering, or related field.
Experience:
3+ years in HSE or manufacturing operations, preferably in a regulated industry.
Technical Skills:
Proficiency in Microsoft Office, Power BI, iObeya, Qualipso, and EHS Desk.
Familiarity with MSDS Online, SEDDA, and risk assessment tools.
Understanding of chemical and biological safety is a plus.
Certifications: OSHA 30 hour (general industry or Construction) or similar certifications are preferred.
Soft Skills:
Strong communication and coaching abilities.
Analytical mindset with attention to detail.
Ability to lead cross-functional teams and influence without authority.
Why choose us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SP
#LI-SP
#LI-Onsite
#vhd
Pursue
progress
, discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$74.250,00 - $123.750,00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
Auto-ApplySR AD, National Acct and Sales Retail
Duluth, MN jobs
Compensation Data
Compensation: This position offers a base salary typically between $140,000 and $219,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
Description
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, National Acct and Sales Retail is responsible for the management of the assigned Customers and account managers. The incumbent will develop the retail strategy for their relevant channel of assigned customers, and the implementation of the Boehringer sales/marketing plan to assure maximum distribution and market penetration of Boehringer products. Responsibilities for this role include achieving net sales, profit, and market share goals, and delivering against customer KPIs. The incumbent will manage a team of account managers, across relevant portfolio of customers. This role will support the leadership of the sales functional by developing key internal relationships, as well as external. This position has responsibility for key additional projects which support the continued development and future strategy of the sales organization.
Remote based role. Locations: Duluth, GA or Seattle, WA
Duties & Responsibilities
Works with and through assigned customers and Key Account Managers to ensure sales performance meets or exceeds annual Company sales and market share objectives.
Implements a sales strategy to be executed through their relevant channel and Key Account Managers.
Exercises fiscal control on allocated operating budgets across multiple customers.
Manages across multiple customers.
Responsible for setting of annual KPIS.
Works to improve to sales bench of the organization, with the Head of Sales.
Utilizes appropriate data sources to develop tactical plans and to develop future customer / channel strategy.
Actively monitors progress of work, cross-functional activities, and accountability.
Plans and executes meetings that effectively implement objectives and strategies as determined by the Company.
Spends appropriate amount of time developing customers, networks, and their relationships to foster Company business.
Leads the senior customer engagement strategy across the channel, ensuring relevant T2T, strategic customer meetings and line reviews are delivered.
Develops positive relationships with Company internal customers, such as supply, marketing, Segment Leads.
Performs all Company business in accordance with all regulations (e.g., EEO, FDA, OSHA, etc.) and Company policies and procedures.
Demonstrates high ethical and professional standards with all business contacts to maintain BIAH's excellent reputation within the community.
Leads special strategic projects as relevant, which will ensure future success of the retail sales team.
Requirements
BS/BA.
Minimum of eight to ten (8-10) years successful commercial industry experience.
Minimum of five to seven (5-7) years retail experience, across Omni channel, ideally in US Mass market, E-commerce, or Retail Pharmacy.
Understanding of retail analytics, economics, supply chain, and consumer insights.
Understanding of the digital environment, e.g., E-Commerce and digital marketing.
Understanding of the US retail environment.
Experience in working cross-functionally.
Project Management Skills.
Proficiency in Excel, Word, Outlook, PowerPoint, and database applications.
Ability to travel.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Sr. AD, Medical Analytics and Insights - Metabolic (Remote)
Ridgefield, CT jobs
**Compensation Data** This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** .
**Description**
The Sr. Associate Director of Business Analytics is responsible for supporting BIPI Sales, Marketing and the Payor team in the following key areas: physician targeting, segmentation, sample optimization, analysis and reporting on the effectiveness of sales and marketing promotional strategies, and performance monitoring. Responsibilities include the conducting, interpretation and communication of advance analytics to support decision making on promotional strategies and effectiveness (ROI and Marketing Mix analysis), support brand/field force planning activities and serve as inputs to the forecasting process.As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees
**Duties & Responsibilities**
+ Provide reliable and accurate reports, analyses and recommendations to senior business leaders to support decision making on promotional strategies and effectiveness.
+ Conduct advanced analytics to brand teams and customer channels in support of brand planning and resource allocation across promotions and channels.
+ Liaison between Marketing and Sales in the development of business tactics and strategies.
+ Communicate insightful and meaningful results to and understand needs of senior brand and corporate managers and share strategic direction with Business Analytics staff. Be able to present to and influence senior management and advice on strategic direction, where required.
+ Develop the technical/behavioral competencies in analysts/department staff through the design and execution of ongoing knowledge sharing and training initiatives.
+ Independently lead strategic projects that inform and impact significant business decisions.
**Requirements**
+ Bachelor´s degree from an accredited institution required.Master´s/PhD preferred.
+ BS/BA in Mathematics, Statistics, Engineering, Business/Data analytics, or a related equivalent with eight (8) years, or Masters degree in Mathematics, Statistics, Engineering, Business/Data analytics, or a related equivalent with six (6) years of healthcare/pharmaceutical industry or academic experience. Experience must also include working directly with product segmentation, benchmarking, score-carding, targeting, and promotion-response modeling.
+ Strong statistical background with extensive modeling experience.
+ Proficiency in SAS and other data extraction and analytical tools such as SQL. Experience with Excel and Power Point.
+ Strong interpersonal abilities, can manage multiple projects and direct reports at the same time.
+ Functional competencies: Analytical skills, Business orientation, influence.
+ Strongly prefer 15+ years of direct experience working in/at a Pharmaceuticals Manufacturer specifically in the role of business analytics for pipeline or in-line products.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Medical Science Liaison (MSL) Allergy Dermatology Dallas/Fort Worth Territory- Remote
Remote
#LI-Remote Location: This position can be based remotely. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require travel. Candidate must live/work within 50 miles of the designated territory (Dallas/Fort Worth TX).
Job Description
The Medical Science Liaison (MSL) is a field based, customer-facing, non-promotional medical and scientific role. Their key objective is to create impact through advancing clinical practice within the territory that leads to improved patient outcomes. The MSL must demonstrate deep therapeutic expertise, understand territory and market influences, engage scientifically with Healthcare Providers (HCPs) and medical experts, manage, and develop their territory and execute all relevant activities in alignment with the medical strategic and tactical plan - while functioning within the Novartis Code of Conduct, Ethics/Compliance policies and Working Practice documents. The MSL will Inform and shape medical strategy through application of a curious mindset to collect impactful and actionable insights, understanding the strategic impact of critical insights.
Major accountabilities:
• The MSL will leverage scientific expertise and market knowledge to establish and build professional relationships and engage with HCPs (including community physicians, pharmacists, medical experts, nurses, and other healthcare professionals) and other thought leaders in geographical area as aligned with medical strategy
• The primary responsibility of the MSL is to engage with customers - customer engagements may include but not be limited to emerging data discussions, clinical trial activities, uncovering barriers in patient journey, understanding market dynamics within territory, exploration of areas of unmet medical need, pipeline discussions, educating on disease state and product, capturing adverse events, and capturing medical insights through all stages of product lifecycle.
• Must demonstrate strategic territory vision and ensure appropriate territory identification, mapping, and planning of Medical Engagements (MEs) and Key Accounts as aligned to medical strategy and in collaboration with internal Novartis colleagues. This includes: Identification of key stakeholders with influence in disease space throughout the product development journey to establish strategies for education, engagement, and partnership. Identification of opportunities for partnership with academic centers, centers of excellence, and/or systems of care to drive impact within the assigned territory. Identification of opportunities to involve HCPs or MEs when a specific medical need is identified (e.g., publications, clinical trial participation, etc.). Identification of opportunities for internal collaboration with other Novartis stakeholders to drive forward therapeutic area, clinical, or product goals as appropriate.
Provide clinical trial support for company sponsored trials and facilitating relevant medical activities, including but not limited to identification of appropriate sites, supporting clinical trials (subject recruitment, protocol questions, SIVs, etc.) at sites, and cross-functional collaboration with Medical Affairs and Clinical Operations colleagues
• Regularly collaborate with internal colleagues (e.g., HEOR, access, marketing, commercial) within the assigned therapeutic area and territory to advance clinical practice while maintaining customer centricity and a One Novartis approach in accordance with Novartis compliance standards
• Maintain in-depth knowledge of assigned therapeutic area and Novartis compounds to serve as a medical resource to customers and internal colleagues
Minimum Requirements:
Work Experience:
Minimum of 3 years' experience in a Field Medical-based position within the pharmaceutical industry or as an MSL is preferred OR 5 years of relevant medical affairs, clinical research, or related experience in a scientific or clinical setting required. Previous experience in assigned or related therapeutic area is preferred.
Strong clinical knowledge including pharmacotherapy, treatment guidelines, clinical research processes, medical expert engagement strategies, and FDA promotional guidelines, regulations, and ethical guidelines applied to the pharmaceutical industry is required.
Excellent interpersonal, communication, and presentation skills are required
Strategic mindset and ability to navigate complex healthcare landscape able to identify, network and partner with medical experts, including thought leaders, large group practices, medical directors, and pharmacy directors is required
Strong personal integrity, teamwork abilities (including ability to network) and a customer focus are necessary
Ability to prioritize, showcase agility, and work effectively in a constantly changing environment.
Ability to gain medical insights, uncover business opportunities for Novartis and leverage internal resources to meet customer needs aligned with Novartis strategy
Education:
Graduate degree in science or healthcare required; doctoral degree preferred (MD, PhD or PharmD
Novartis Compensation and Benefit Summary:
The pay range for this position at commencement of employment is expected to be between $145,600.00 and $270,400.00 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145,600.00 - $270,400.00
Skills Desired
Building Construction, Business Analysis, Business Networking, Clinical Practices, Clinical Research, Clinical Study Reports, Collaboration, Curious Mindset, Disease Management, Diversity & Inclusion, Drug Development, Epidemiology, Medical Information, Medical Research, Medical Writing, Microsoft Word, Phase Iv Clinical Trial, Product Placement, Scientific Support
Auto-ApplyAD, Compliance Inquiries & Audits
Remote
Band
Level 5 Novartis has an opportunity for an Associate Director, Compliance Inquiries & Audits, who will perform internal investigations and root cause analyses (RCA) of content generated by US Integrated Marketing, as part of the Compliance & Risk Operations team. This role is crucial for resolving deviations related to marketing content, communicating with stakeholders, and discreetly responding to audits and legal queries to ensure marketing compliance, confidentiality, integrity, and operational excellence.
The ideal location for this role is East Hanover, NJ but remote work may be possible (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. If associate is remote, all home office expenses and any travel/lodging to East Hanover, NJ for periodic live meetings will be at the employee's expense. This position will require 5-10% travel to various Novartis sites and external locations. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager.
Job Description
Key Responsibilities:
Intake and triage of identified content risks, gaining insights into circumstances, mitigators, and break downs for appropriate resiliency strategies
Assessing and validating potential policy or process breakdowns through comprehensive fact gathering, including conducting informal interviews and thorough document reviews.
Determining the root cause of confirmed breakdowns and mapping corrective actions to address these root causes effectively.
Identifying proactive measures to prevent policy or process breakdowns from reoccurring.
Ensuring the implementation and follow-through of corrective and preventative actions through necessary follow-up, in partnership with AD, Remediation.
Maintaining detailed documentation relevant to potential compliance breakdowns and reporting findings comprehensively, operating with discretion and confidentiality.
Identifying appropriate metrics to attach to remediations and measuring the potential effectiveness of these remediations.
Assessing data over time to identify trends and opportunities for large-scale remediations and organizational priorities
Project management and process ownership, being agile to drive optimization aligned to organizational priorities
Essential Requirements:
Bachelor's degree in a relevant field (e.g., Business Administration, Risk Management, Compliance, Enforcement). Advanced degree preferred.
Minimum of 7 years of experience in a similar role within the pharmaceutical or highly regulated industry, with a strong background in compliance, risk management, and investigations
Advanced understanding of how pharmaceutical marketing organization operates and the relevant controls they use to manage risk, including content review and production processes
Strong analytical and deductive reasoning skills with strong written communication skills
Approachable communication style that respects others and balances firmness with empathy
Awareness of the various types of biases and how to ensure they are not introduced into work product
Skilled in influencing without direct authority and capable of effectively communicating with individuals at various levels of the company
Purpose-driven, high-integrity, clear, and compassionate business partner, positively impacting associate and organizational success
Novartis Compensation Summary: The salary for this position is expected to range between $132,300 and $245,700 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
***************************************************************************************
Salary Range
$132,300.00 - $245,700.00
Skills Desired
Agility, Cross-Functional Collaboration, Customer Engagement, Customer Experience, Customer Insights, Data Analytics, Data Strategy, Digital Marketing, Marketing Strategy, Media Campaigns, Product Marketing, Stakeholder Engagement, Stakeholder Management, Waterfall Model
Auto-ApplyAutomation Engineer
Lebanon, TN jobs
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Lilly is currently constructing an advanced manufacturing facility for production of advanced therapy medicinal products (ATMPs) located in Lebanon, IN. This facility is intended to provide current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations.
Responsibilities:
As an Automation Engineer you will provide automation design and oversight to the delivery of Lilly's new Lebanon LP2 facility. Collaborate with system integrators to deliver all aspects of Automation. Support key corporate initiatives such as life cycle management, Engineering information management, and cyber security. Drive automation governance and replication Tier 1 equipment, architecture, and Automation/IT systems and solutions.
* Safety - Work safely and continually looks for improvements in personnel and equipment safety, ensure safe design and operation of new equipment, ensure automation design reflects safety concerns for operations and maintenance.
Automation Design
* Design and implement Automation Strategies that allow the operators to interact and manipulate the process in compliance with cGMP batch manufacturing requirements.
* Generate/Update Design SDLC documentation.
Automation/Control Discipline
* Partner with colleagues to properly support and enhance the Automated Systems and Equipment including the adjustments on PID Control Parameters.
* Perform solution assessment and performance reviews and verified the proper and efficient operation of the automated systems.
* Partner with colleagues to support the discipline through solution assessment, replication, and development.
* Manage tools, and implement engineering standards, master specifications and best practices.
* Provide technical coaching and consultation to other Lilly engineers and facilitate shared learning forums.
* Support Projects and the integration of new equipment/technologies to the manufacturing workflow.
* Support Automated System Commissioning and Qualifications.
* Technology and Innovation. Keep current on external trends and practices to evaluate technology for application within Lilly.
Basic Qualifications:
* Bachelor's Degree in Engineering or related field.
* 5+ years of experience in automation or process control.
Additional Skills and Preferences related to the roles we are recruiting:
* Experience with Emerson DeltaV Systems, Rockwell Automation, OSI/PI Historian, or related automation and control platform.
* Expertise in Rockwell Automation Platforms including FactoryTalk View SCADA and ControlLogix PLC's.
* Knowledge of Drug Product manufacturing processes including formulation, equipment preparation, and filling.
* Knowledge of Drug Substance manufacturing processes including large and/small molecule and Batch.
* Knowledge of plant utility systems including purified water, clean steam, process air, and recovery and environmental systems.
* Knowledge of building management systems (HVAC) and qualified building management systems for critical monitoring.
* Knowledge related to ISE S95 principles and IT/Automation integration.
* Experience in a pharmaceutical or GMP industry.
* Experience in OSI/PI Data Historians or related technology.
* Experience in Microsoft operating systems, virtual environments, and networking.
* Communicate effectively with internal customers, business partners, and leadership including written and visual presentations.
* Experience in Automation Project Delivery related to Major Capital delivery.
* Technical leadership on automation project delivery
Additional Information:
* This is an onsite position that requires onsite presence the majority of the time, with some flexibility for working from home depending on business need.
* This position is based in Lebanon, IN and is not a fully remote role. This would require relocation to Lebanon, IN area (within commuting distance).
* Some business travel will be required for this role including OUS. Business travel typically includes design review meetings at A&E firms and equipment OEM's, Factory Acceptance Testing, and training. Travel is not expected to exceed 10-20%.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-Apply2026 Summer Internship Program: Global Regulatory Project Management & Strategic Planning (RPM&SP)
Boston, MA jobs
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure global regulatory project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless execution of the GRT goals. Oversees and provides regulatory operational support for programs in the Therapeutic Area Unit (TAU). Expertly leads cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for highly complex, novel, and critical programs by providing expert and effective Project Management leadership, oversight, direction and planning
.
The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning (RPM&SP) group in advancing regulatory milestones. This role will provide hands-on experience in health authority meeting planning, developing submission timelines, and supporting scenario planning for key regulatory deliverables.
How You Will Contribute:
The RPM&SP intern will provide valuable support in developing timelines, scenario analyses, and health authority meeting logistics-activities that directly impact the group's ability to meet regulatory milestones efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational excellence. In addition, the intern's fresh perspective and analytical work will enhance the team's ability to anticipate challenges and optimize submission planning
Responsibilities:
Assist in planning and logistics for health authority (HA) meetings, including preparation of timelines, coordination of materials, and tracking key actions.
Support the development of submission timelines and scenario analyses to evaluate regulatory strategy options.
Contribute to the preparation of regulatory documentation and project tracking tools.
Internship Development Opportunities:
The intern will gain hands-on exposure to the regulatory strategy and operations function within Takeda's GI therapeutic area. By supporting health authority meeting preparation and submission planning, the intern will learn how cross-functional teams collaborate to advance innovative therapies through regulatory milestones. This role provides practical project management and regulatory operations experience that builds a strong foundation for a career in global drug development.
Job Requirements:
This position will be Fully Remote
Currently pursuing a Bachelor's or Master's degree in Life Sciences, Regulatory Affairs, Pharmacy, or related field.
Strong organizational, analytical, and communication skills.
Interest in regulatory strategy, drug development, and project management.
Proficiency with Microsoft Office (Excel, PowerPoint, Project/Timeline tools a plus).
Internship Eligibility
Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship
Must be currently enrolled in a degree program graduating December 2026 or later
The internship program is 10-12 weeks depending on the two start dates (May 26th-August 14th or June 15th- August 21st)
The intern must be able to commit to one of these time frames
Able to work full time 40 hours a week during internship dates
Takeda does not provide a housing stipend or relocation support for the U.S Summer Internship Program
Program Highlights:
Hands-on experience with real projects and responsibilities
Dedicated mentorship program pairing interns with experienced professionals
Networking opportunities with industry professionals and fellow interns
Internship events focused on professional and skills development
Exposure to multiple business areas or departments within a Pharmaceutical Organization
Applications will be accepted between November 7th - January 2nd
Takeda Compensation and Benefits Summary
We understand compensation may be an important factor as you consider an internship opportunity. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Hourly Wage Range:
$21.00 - $46.00
The estimated hourly range reflects an anticipated range for this position. The actual hourly wage offered will depend on the candidate's school year/level to be entered following completion of internship. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. internship benefits vary by location and may include:
Paid sick time
Civic Duty paid time off
Participation at company volunteer events
Participation at company sponsored special events
Access to on-site fitness center (where available)
Commuter Benefit: To offset your work-commute expenses, Takeda provides U.S. employees with a fixed monthly subsidy to be used for either public transportation (transit) or parking.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypePaid Intern (Fixed Term) (Trainee) Time TypeFull time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Auto-ApplyAD, Access & Reimbursement RLT - Los Angeles, CA - Remote
Remote
The Associate Director, Access & Reimbursement, RLT (Radioligand Therapy) is a remote/field-based role that covers the following states but not limited to, Los Angeles, Orange, Thousand Oaks, Santa Clarita & Ridgecrest, CA. Candidate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border.
The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care.
ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects.
ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates).
Job Description
Key Responsibilities:
Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows.
Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices.
Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products.
Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement issues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines
Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments.
Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay).
Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed).
Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education.
Collaborate with aligned cross-functional associates within NPC (see above) to share insights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement.
Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (understand and ensure compliance with HIPAA and other privacy laws and regulations and internal Company compliance guidelines).
Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes.
Buy and Bill Specific
Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel.
Responsible for educating HCPs using approved materials regarding acquisition pathways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and decentralized acquisition, and use of alternative channels such as white bagging, clear bagging, brown bagging, and alternate site of care for administration.
Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement.
Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams.
Accountable for engagement with non-prescribers in regard to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, revenue cycle managers, etc.
Radioligand Therapies Specific
The ADAR will be a critical partner to the Novartis Patient Support (NPS) customer engagement team on supply capacity, site procurement eligibility, as well as a customer facing resource for communications on orders and logistics.
Understand RLT key priorities in core disease areas, financial goals, and site initiatives to influence overall account and regional business strategies.
Assess and understand site and/or other appropriate organizations' level of readiness for procurement of nuclear medicines and billing to facilitate orders for products and so that they can engage and educate on procurement systems and processes, access, and reimbursement. Be able to understand where gaps in procurement exist and work with Cross-Functional partners to resolve.
Partner with the customer engagement teams to assist the communication and facilitation of procurement and logistics with both the site and the local field teams. (e.g., procurement, logistics processes and timing, and education regarding available rebate offerings, as appropriate) as well as patient-specific support (benefit verification, PA, appeals, copay programs and applicable rebate offerings)
Partner with Market Access to support follow up to help ensure completion of purchase agreements & GPO forms by acting as liaison for RLT Access Lead (RAL) for new site onboarding.
Responsible for supporting treatment site onboarding to include RAM license, W9, & PRD preferences
Major accountabilities apply to therapy, diagnostic and theragnostic treatment centers.
What You'll Bring to the Role:
Education: Bachelor's degree required; Business and/or biological science education preferred. Advanced degree preferred.
Essential Requirements:
5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s).
Experience working with highly complex practices and/or health systems to establish access and acquisition pathways.
Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access.
Deep expertise and experience integrating manufacturer-sponsored patient support programs.
Experience with specialty products acquired through Specialty Pharmacy networks
Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail)
Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region.
Must live within assigned territory.
Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up.
Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated.
Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role.
The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
Desirable Requirements:
Experience leading and delivering presentations to C-level account executives.
Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates.
Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs.
Strong capabilities in the areas of customer focus, collaboration, business acumen, communication, and presentation skills.
This position requires significant use of a company provided vehicle and maintaining good driving record
This is a field-based customer engaging position
Control business expenses related to field activities (i.e. travel, customer meetings) and provide timely expense reports to manager.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $160,300.00 and $297,700.00/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$160,300.00 - $297,700.00
Skills Desired
Access And Reimbursement Strategy, Agility, Analytical Skill, Analytical Thinking, Cross-Functional Collaboration, Customer-Centric Mindset, Employee Development, Finance, Go-To-Market Strategy, Healthcare Sector Understanding, Health Economics, Health Policy, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategy, Negotiation Skills, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Value Propositions, Waterfall Model
Auto-ApplyDesign + Human Factors Engineering Senior Director
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Position Title: Design + Human Factors Engineering Senior Director -DDCS
Department Name: Delivery, Device and Connected Solutions
Purpose:
In 1992, Eli Lilly and Company established the Delivery Device business to create, develop, launch and continuously improve proprietary delivery device systems. This business is unique to the broader Lilly Research Labs organization due to its focus on patient-centered delivery system solutions, its innovative approach to delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery, Device and Connected Solutions (DDCS) organization leverages many alliances in design and manufacturing to rapidly convert proprietary product concepts into products that meet the users' needs and intended uses. This business enables over $30 billion in pharmaceutical sales and is projected to drive company growth in the coming years.
In response to this growing portfolio and increasing global regulatory expectations, the DDCS organization requires a Design and Human Factors Engineering Senior Director to provide leadership to support product innovation and product development for delivery and device systems at Eli Lilly and Company. This position is responsible for providing strategic direction, execution and reporting of design and human factors activities across all medical device, combination product and packaging programs, according to current regulations and appropriate guidelines within the medical device and biopharmaceutical industries.
Position responsibilities:
Design and Human Factors:
Lead and grow a top-tier engineering and science organization, which includes expertise in design and human factors engineering that is applied across the portfolio.
Ensures that:
Human capabilities and limitations are adequately reflected in the system requirements
Human performance characteristics and their associated cost, benefits, and risks assist in deciding among alternatives (especially since lifecycle operation and support costs are often largely dependent upon personnel-related costs)
Human performance and safety risks are appropriately addressed in planning.
The staff is highly trained in Human Factors processes, relevant standards (IEC 62366, ANSI/AAMI HE75) and FDA guidance.
Human Factors Standards are appropriately documented in the Design Control Quality System.
Project milestones are met by identifying and managing risks and escalating as appropriate.
Functional budgets and project forecasts are maintained in compliance with P&L
People:
Responsible for developing and managing the Design + Human Factors Engineering team.
Provides leadership, feedback, coaching, performance and career development support to direct reports.
Ensures career development discussions, talent assessment, and succession planning are in place for employees.
Builds and executes a comprehensive long-range recruiting strategy and technical succession plan to maintain a highly competitive cross-functional technical organization.
Strategy / Corporate Integration:
Given the anticipated growth in the delivery business both in terms of the existing base of business and future ventures, the Design & Human Factors Engineering Senior Director will be accountable for the execution of a Delivery and Device Strategy with other members of the management team.
The delivery strategy and project workload are closely linked to that of the Business Units, Sales Affiliates, Medical, Manufacturing and Marketing. The position would work closely with the above groups to consistently align the strategies and projects.
Partner with Regulatory to serve as an opinion leader in the drug delivery device and pharma industry on human factors and help draft policy positions across Lilly and the industry
Relationship Management:
Ensure compliance with external collaborations
Create and maintain effective relationships and alignment with Lilly partners external to DDCS (e.g. Quality, Manufacturing, Regulatory, Digital Health, Business Units)
Build strong relationships with external vendors and lead external collaboration efforts to support development strategies as they may evolve
Minimum requirements:
MS in Engineering with 10+ years or PhD in Engineering with 5+ years of delivery device design and development experience.
Experience with regulatory agencies interactions and/or regulatory submissions of delivery devices and combination products.
Experience working within a Sponsor organization
Working knowledge of HF regulatory requirements, protocols, IRBs, Usability studies and reporting.
Human subjects research bioethics and study design
Prior supervisory experience of team organization
Ability to work effectively across boundaries
Demonstrated quality mindset, ability to influence and leadership capabilities
Additional Skills and Preferences:
Understanding of and experience with device/drug regulations, standards and guidances as they pertain to specific functional responsibilities (e.g. CFR 820.30, ISO 13485, ISO 14971, IEC 62366, ANSI/AAMI HE75)
Business skills (capital and expense differentiation and impact on COGS and variance).
Communication and interpersonal skills necessary for broad interactions at all levels of the corporation.
Broad integrated technical knowledge of system and design engineering, product development, and commercialization (device, container closure, packaging, etc.).
Experience working in a diverse networked technical organization with proven skills in managing suppliers and alliance partners.
Leadership skills with previous experience managing technical personnel and alliance partnerships
Demonstrated ability to lead cross-functional teams
Additional Information
Position Location: Indianapolis, IN
Ability to travel ~10-20% of the time, both domestic and international
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$163,500 - $264,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplySenior Associate Director, Regulatory Excellence Team Lead (Remote)
Remote
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Senior Associate Director, Regulatory Excellence Team Lead directs, leads, and manages the Regulatory Affairs (RA) capability leads. The incumbent thinks beyond the RA function and constantly identifies areas for improvement in a patient-centric, forward-looking way to enable current and future processes which result in excellence of RA. This will be combined with efficient processes to allow for compliant operations in RA. The incumbent is a critical driver of RA excellence within BI. This role is managing the capability leads for RA and will be an important contributor to drive the regulatory excellence and operations function.
The SR AD, Regulatory Excellence Team Lead is responsible for the development of capability roadmaps, standards and capability strategy following the guardrails of the ever-changing regulatory environment and the global department strategy which is provided by the GRA Leadership Team. This role ensures capability governance, alignment of standards, deliveries and cross-capability exchange within GRA and beyond. The incumbent provides leadership and expertise to cross-functional teams working around Regulatory Affairs and beyond (e.g., HPQ, PSPV, CD&O, xTA, IT...).
Duties & Responsibilities
Leads and manages the Capability Leads in GRA.
Coaches/directs/oversees team members to design, develop, and implement projects, on time and in budget. Performance of established processes is monitored and subject to process improvement as necessary.
Develops overall vision for the GRA Excellence and the GRA Capability strategy and creates a roadmap and prioritization, that anticipates the demands of pipeline and the changing Regulatory Environment while keeping patients, regulatory needs, priorities and resources at front of mind.
Oversees and seeks for alignment across capabilities in GRA and beyond.
Strongly considers external trends in health authorities and the competitive environment.
Steers as necessary strategic external partnerships/engagements that are part of a global process environment and system implementation for Regulatory Operations / Regulatory Affairs.
Requires connectivity and understanding of the internal and the external environment, alignment with other Capability areas in GRA, end users and key stakeholders demands and needs, cross-functional and vendor systems and collaboration models. Focus is across Capabilities and standalone Projects/Programs.
Ultimately accountable for alignment of GRA capability roadmaps, the capability framework/standards, definition of over-all process-landscape, implementation of quality parameters in GRA-processes and for continuous process improvement for GRA capabilities.
Oversees overall framework with regards to Processes and Capabilities for GRA.
Ensures cross-capability impact of process-changes, projects and implementation of IT solutions are taken care of.
Ensures capability development and deliverables for GRA which includes:
Stakeholder feedback and commitment.
AS-IS process analyses.
Process governance and documentation / Process architecture.
Designed IT solutions aligned with the process goals and business case.
Process monitoring plans which appropriately depict process performance.
Process measures/metrics and technical feasibility.
Architectural integrity during each life cycle development stage.
Participation, contribution to the inspections/audits for the defined capability area.
Oversight of process NCs/CAPAs, roadmaps, identifies problems, gaps and opportunities for process improvement.
Contributes to the development of personnel, with a focus on GRA-Capability Leads. This is done through:
Coaching/directing (as appropriate based on individual and situation) of Capability team members.
Optimizing capability development flow.
Awareness and introduction of latest functional and regulatory developments in the pharma industry.
Supporting consistency and compliance.
Establishing area-relevant standards.
Encouraging innovation.
Requirements
Master's degree (e.g., MBA, MSc) or comparable professional education, preferably in medicine / science, paramedical science, computer science, business management or related experience.
Five to seven (5-7) years' experience in Regulatory Affairs, business/process consulting, project management, external relationship management, business architecture management, and/or implementation of systems in the GxP area, ideally in a global setting.
Demonstrates the ability to obtain maximum results from meetings in which interests conflict both in terms of content and maintaining good relations.
Solution-oriented and collaborative ways of working.
Visionary: Ability to step back from one's daily routine, explore ideas for the future, regard the facts from a distance and see them in a broader context or in the longer term.
Develops (& discovers) individuals & builds effective teams.
Customer orientation: Ability to engage with customers, building strong customer relationships and delivering customer-centric solutions actively and truly.
Stakeholder management: Ability to effectively build and manage relationships with many different (internal & external) stakeholders, engaging with them in a planned and meaningful way in pursuit of our strategic objectives, and feeding intelligence back across BI to deliver maximum.
(Agile) Project Management: Ability to initiating, plan, executing, controlling and closing projects including reporting on results and/or lessons learned.
Effective Communication & Influencing Skills: Ability to have a positive impact on others, to persuade or convince them to gain their support. Excellent public speaking and presentation to large audiences, fluent in written and spoken English.
Solid Medical/Scientific understanding, incl. general understanding of Pharma industry, rules and regulations.
Financial acumen: Ability to interpret and apply understanding of key financial indicators to make better business decisions.
Effective cross-functional collaboration: Ability to develop and maintain relations, alliances and coalitions within and outside the organization and to use them to obtain information, support and cooperation.
Curiosity, innovative thinking: Ability and a strong desire to know or learn something, inquisitiveness, interest, curiousness.
Digital savviness: Displays the ability to use technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
Integrity and Compliance Mindset: Adherence to the standards, values and rules of conduct associated with one's position and the culture in which one operates.
Pro-active result driven behavior: The ability to take direct action to attain or exceed objectives.
Outcome orientation: is driven by outcomes and results.
Data-driven insights generation: Ability to take decisions based on data analysis and interpretation.
Efficiency: Discipline & accountability.
Demonstrated competencies in Agility, Accountability and Intrapreneurship: fast decision-making, flexibility, ownership, outcome-based thinking, purpose orientation, smart risk-taking.
Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.
Compensation
This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.
TA Training, Medical - ILD (Remote)
Ridgefield, CT jobs
**Compensation Data** This position offers a base salary typically between $170,000 and $269,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. **Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunities for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Customer Facing Trainer (CFT) will lead the alignment, development and delivery of Therapeutic Area/Commercial, Business Area or Medicine related training curriculum and content in support of their assigned primary business area of focus to support new hire on boarding, ongoing product and engagement skills training, and collaboration with cross-functional teams to ensure alignment with strategy and compliance standards.
The CFT will act as point person for their assigned client group, working closely with Medical. The incumbent will also be responsible to learn and maintain cross business area knowledge to ensure scalable support to all client groups based on business needs of Human Pharma.
Responsibilities for this role will include the strategy, design, development, approval, creation, execution, delivery, and evaluation of Business Area/Product/Therapeutic Area/Medicine Training, and engagement skills for therapeutic franchise(s), including all in-line and/or launch product(s), when necessary. In addition, this role is responsible for the oversight of a training vendor when engaged for additional resourcing.
The CFT will be responsible for defining need and budget allocation for use of vendor/contract resources alone or in conjunction with Leader for resources for the area in which they are assigned.
**Duties & Responsibilities**
+ Ensures that comprehensive content including business, product or therapeutic area training and curricula development is created, approved, delivered, and measured to support and align with Franchise /Company goals and priorities.
+ Proactively provides strategic recommendations. Includes working diligently to influence outcomes across entirety of their assigned business team, inclusive of Brand Partners, Executive Director, Sales leadership, and Franchise lead. Recommendations should incorporate both global organization initiatives as well as the specific needs of the local business area to ensure a holistic approach to all employees training
+ Appropriately inquires and challenges key stakeholders (including Area VPs, Marketing TA VPs), customers and vendors on training requests and clearly communicates risks and benefits as part of determination for implementation.
+ Works closely with collaborative partners, such as Marketing, Sales, Customer Facing Excellence, and HP Operations to develop strategies and incorporate these into training programs/deliverables.
+ Accountable for cross-functional project management and application of knowledge of beyond-assigned therapeutic area / brand's clinical profile, disease state, and competition/marketplace as part of curriculum development.
+ For training materials, ensures that they have independent ownership, leads the MLR review process cross-functionally by partnering with other HPT&D members (if applicable), Medical, Legal, and Regulatory reviewers, the HP Review Committee Operations Team, and applicable vendor partners.
+ Delivers virtual or live classroom facilitation as well as live coaching to trainees, with written feedback to Sales, Marketing, Managed Markets and/or Field Based Medicine Leadership, addressing strengths and developmental areas when increased demand requires.
+ Manages training content across all learning platforms (i.e. Learning System, BI Edge, Mobile, Pedagogue)
+ Develops a solid network of internal customers and stakeholders and uses this network to advance training initiatives and overcome challenges/barriers to training execution.
**Requirements**
+ Bachelor's degree required.
+ Seven-plus (7+) years' experience in US pharmaceutical industry, including five-plus (5+) years of US pharmaceutical sales and two (2) years training or relevant experiences preferred.
+ Leadership Experience is preferred, not required.
+ Demonstrated high energy level, positive attitude, output driven and team orientated.
+ Experience in ADDIE/Instruction Design (analysis, design, development, implementation, evaluation) preferred.
+ Exceptional project management skills.
+ Facilitation experience and strong presentation skills required.
+ Demonstrated coaching experience.
+ Experience working with cross functional partners preferred.
+ Proven ability to lead without authority.
+ Understanding of medical, legal and regulatory review process is desired.
+ Excellent organizational, communication and interpersonal skills, ability to access and influence various functional areas, and motivate groups to action.
+ Demonstrated ability to achieve results in a highly matrixed organization.
+ History of successful performance.
+ Thorough understanding of both the franchise model and/or specialty business environments.
+ BI Regional Training Lead experience preferred.
+ Proficiency in MSOffice, Outlook, PowerPoint and BIPI computer applications.
+ Ability to travel - Assumes ~25%-75% travel (including overnight travel).
+ Affinity for working with Technology Platforms/Applications:
+ Mobile Apps & PC Software and/or systems.
+ Learning Management System (LMS).
+ Advanced degrees in health sciences up to doctorate degrees are strongly preferred.
+ Minimum three-plus (3+) years' experience in Medical Affairs roles strongly preferred.
+ Demonstrated strategic mindset in translating Medical Affairs priorities into actionable training strategies, adapting approaches based on scientific advancements and market dynamics.
**Eligibility Requirements** :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
**Additional Duties & Responsibilities:**
+ Creates and maintains training content and TA specific learning curriculum across all applicable CDMA roles aligned with Medical Affairs strategy and scientific narrative.
+ Conducts field visits with MSLs in coordination with MSL Managers to support role performance and to stay abreast of how scientific narratives are communicated/supported in the field.
+ Develops/conducts scientific knowledge training, support insight gathering training and review sessions for Field Medical, CCC and SA team members at all experience levels.
+ Co-develops the scientific learning journey and curriculum for respective TA across all experience levels (new hire and existing employees).
+ Conducts customer engagement and business acumen training for field medical respective to TAs.
+ Serves as primary touchpoint for scientific knowledge training and development for onboarding, exam review and final verbalization preparation for field.
+ Liaises between field teams, Corporate & local TA content owners, and the CX team for content needs.
+ Aligns with Directors of MSL, MCFE, CCC, and SA teams regarding needs & priorities, onboarding processes, and training protocols. Coordinate with CDMA team members to build and maintain therapy area specific LOS curriculum.
+ Supports scientific knowledge curriculum development for other medical teams/contractors.
+ Stays updated on scientific advancements & industry trends, and communicates updates to supported teams.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Senior Specialist - Account Management (Remote)
Plymouth Meeting, PA jobs
The Trade Operations Senior Specialist - US Market Access Operations is responsible for managing and optimizing the end-to-end order to cash process, with a focus on overseeing accuracy of third-party logistics (3PL) providers. This role involves overseeing the timely and accurate processing of customer orders, ensuring effective invoicing, managing accounts receivable, and maintaining strong relationships with customers and internal stakeholders. The Senior Specialist will also be tasked with analyzing and improving current processes, implementing best practices, and ensuring compliance with company policies and regulations.
The ideal candidate should possess advanced proficiency in SAP, strong analytical, problem-solving, and organizational skills, meticulous attention to detail, and proficiency in ERP systems and Microsoft Office Suite. They will be responsible for supporting data integrity between the Cardinal 3PL Elite ERP system and Athena SAP. Exceptional communication and interpersonal abilities allow them to build and maintain robust relationships with customers, internal stakeholders, and 3PL partners. They are proactive, self-motivated, and capable of working both independently and collaboratively to optimize the order to cash process and enhance customer satisfaction.
Responsibilities
• Oversee the order to cash process, including order management, invoicing, collections, and cash application, in coordination with 3PL providers.
• Ensure timely and accurate processing of customer orders and invoices, working closely with 3PL partners to manage inventory and fulfillment.
• Manage accounts receivable, including monitoring aging reports and following up on outstanding payments.
• Utilize SAP for order to cash activities, including data entry, reporting, and process optimization, ensuring effective integration with 3PL systems.
• Serve as the primary point of contact for group mailbox, responding to customer inquiries related to order monitoring, damage claims, product shortages, and other service needs.
• Perform monthly audit responsibilities in cooperation with finance partners.
• Ensure compliance with company policies, procedures, regulatory requirements, and 3PL agreements.
• Collaborate with cross-functional teams and 3PL partners to optimize the order to cash cycle and enhance customer satisfaction.
• Develop and maintain strong relationships with customers, internal stakeholders, and 3PL partners to resolve issues, improve processes, and collaborate with closely-related teams.
Required Education, Experience and Skills
• Bachelor's degree in Finance, Accounting, Business Administration, Supply Chain Management, or related field.
• Minimum of three years of experience in order to cash, accounts receivable, or related roles, with experience in managing 3PL partnerships.
• Strong understanding of order to cash processes, 3PL integration, and best practices.
• Excellent analytical, problem-solving, and organizational skills.
• Strong communication and interpersonal skills, with the ability to manage relationships with 3PL partners.
• Proficiency in ERP systems, 3PL management systems, and Microsoft Office Suite (particularly Excel).
• Ability to work independently and as part of a team.
Preferred Experience and Skills
• Experience with wholesaler/distributors and specialty pharmacies is highly desirable.
• Order to Cash (OtC) experience with customers is desirable.
• Previous experience with Cardinal 3Plink data is desirable
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$103,100.00 - $175,300.00
Please Note: Pay Ranges are Specific to local market and therefore vary from country to country
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Auto-ApplySecOps Engineer - Identity Operations Tech Lead
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Are you eager to make a significant impact in the cybersecurity field? We are seeking a Technical Lead role to infuse our team with innovative ideas and daring solutions. In this position, you will play a crucial role in delivering how our organization ensures secure, appropriate, and timely access to enterprise resources, while also supporting the capabilities that help us achieve and sustain our Identity and Access Management strategy.
What You'll Be Doing
The SecOps Engineer- Identity Operations Tech Lead role of Identity and Access Management (IAM) is a technical leadership role responsible for the delivery and support for the company's 24/7 identity platforms and services.
This role plays a critical part in ensuring the secure and efficient support of identity and access services within our organization. The responsibilities will encompass day-to-day operations, incident management, change management, and problem resolution related to IAM focusing on Authentication services. This role will also collaborate with cross-functional teams to maintain compliance, address risks, and enhance our IAM program. This includes working closely with the Operation Manager, the Service Leads and other Technical leads to ensure alignment of priorities, allocating resources effectively, and driving operational excellence.
What You'll Bring:
Team and Technical Leadership:
Recruit, hire and develop a high-performing identity operation engineers.
Provide coaching, career development, performance management and professional growth opportunities.
Foster a culture focused on innovation, continuous learning, and operational discipline.
Cultivate a diverse and inclusive team fostering different perspectives and backgrounds.
Keep abreast of the latest developments in IAM technologies, security threats, and regulatory changes.
Drive the adoption of innovative and creative solutions to address complex, global IAM problems.
Serve as technical lead and an escalation point for team members.
Operational Excellence:
Provide technical leadership in the execution and processes for escalations, incident management, change management, problem resolution and continuous improvement that enable the support of 24/7 services.
Continuously monitor IAM systems performance and health to ensure optimal operation. Perform regular maintenance tasks to prevent issues.
Respond promptly to system alerts and incidents, troubleshoot issues, and implement solutions to restore services as quickly as possible.
Manage and maintain all components of IAM systems. Ensure that all systems are up-to-date with the latest patches and security updates.
Analyze system performance metrics and make recommendations for improvements. Implement changes to enhance system efficiency and reduce downtime.
Maintain detailed documentation of system configurations, procedures, and incident reports. Provide regular status updates and reports to management.
Work closely with other IT teams, developers, and stakeholders to ensure seamless operation of services. Communicate effectively to resolve issues and implement changes.
Assess current system capacity and plan for future growth. Ensure that resources are allocated efficiently to meet demand.
Provide technical support to users as it pertains to issues and requests on Identity services.
Support response to audit and compliance requests pertaining to Identity services.
Develop and implement solutions to resolve identified problems. Ensure that solutions are tested and validated before deployment.
Perform detailed root cause analysis and document findings. Develop and implement corrective actions to prevent recurrence.
Proactively identify opportunities for process improvements and implement best practices to enhance problem management processes.
Your Basic Qualifications:
Bachelor's degree in Computer Science, Engineering or related technical field.
5+ years of proven experience in supporting, delivering and securing Identity and Access Management services.
5+ years technical experience with Entra ID and/or Active Directory.
5+ years of experience with authentication and authorization technologies and federated identity standards and protocols (multifactor authentication, certificate-based authentication, LDAP Kerberos, OAuth, SAML, OpenID Connect).
Additional Preferences:
Experience in privileged access management including CyberArk.
Experience with encryption, secrets management. internal certificate authority, public certificate provisioning, enabling certificate management, and/or digital signatures.
Experience with Microsoft Identity Manager.
Experience with IT service management (ITIL).
Effective collaboration with other technical counterparts, Leaders and Stakeholders, to deliver and support IAM solutions.
Ability to work with a distributed and virtual team.
Critical thinking, analytical skills, and thought leadership.
Excellent communication and presentation skills, and ability to adapt messaging for diverse audiences.
An understanding of common services used in cloud-based architecture, with experience in AWS and/or Azure, and awareness of cloud platform security and controls.
Relevant certifications such as CISSP, CISM, or similar.
Additional Information:
Remote or Hybrid Onsite if in Indianapolis, IN
Expected Shift Hours: 9:00 am - 6:00 pm US Eastern Standard Time (EST)
Participate in weekend on-call once per month
Travel 10-15 %
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,750 - $198,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyAssoc Director-Imaging Portfolio Project Management
Remote
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.
Organization Overview:
This position will support delivery of Lilly Imaging's molecular imaging agents and biomarkers portfolios by
leading cross-functional teams to develop and drive robust, integrated project plans
continuously optimizing processes through tools and capabilities; and,
supporting modernization of the Lilly Imaging infrastructure and business operations reporting
Responsibilities:
Support Portfolio Delivery through Project Leadership
Work with cross-functional teams in Lilly Imaging (Research & Discovery, clinical development, Imaging Operations, Medical, Regulatory) and key business partners such as Tech@Lilly, CMC, Clinical Design & Delivery, Radioligand Therapy (RLT) to develop and deliver project plans that encompasses all project management knowledge areas (timeline, scope, risks, communications; budget where applicable)
Hold project teams accountable for achievement of key deliverables in alignment with the project plan and corporate quality standards
Develop and implement team communication plans, decisions, risks / issues to stakeholders; maintain documentation and create visualizations and messaging upward and across organization
Help manage the organization's various portfolios of work (clinical, non-clinical, data and digital) for different therapeutic areas (Neuroscience, Oncology, Immunology, Diabetes) to identify and communicate integration risks and impacts across projects, and create milestone roadmaps
Continuously Improve PM Capabilities, Competencies, and Business Processes
Support the expansion of PM capabilities and competencies throughout Lilly Imaging and key business partnerships through applied PM tools and techniques, and shared learning
Lead special projects as needed to optimize business processes; expertise in Smartsheet portfolio management and reporting capabilities a plus
Support Imaging Infrastructure and Business Reporting Modernization Efforts
Partner with peers and functional leaders to identify modernization and optimization opportunities
Liaise with Tech@Lilly and Lilly business functions to identify and build implementation plans that leverage needed capabilities and tools
Create and implement change management plans to support adoption of new processes and tools
Basic Requirements:
Bachelor's degree with at least 10 years of project management experience in the radiopharmaceutical or pharmaceutical industry, with a proven track record of leading complex projects within Clinical Development
Proficiency with various project management tools (e.g., MS Project, Smartsheet, Jira) and methodologies (e.g., Waterfall, Agile)
Proficiency with Microsoft Word, Excel, PowerPoint, Project and working in O365 platform
Strong problem-solving skills; able to anticipate and recognize issues and barriers, diagnose root causes, validate/confirm, and propose creative alternatives to influence corrective actions
Excellent verbal and written communication skills, with the ability to engage effectively with technical and non-technical audiences, and communicate clearly and concisely with leadership
Ability to work in a fast-paced, dynamic environment and adapt to changing priorities.
Additional Skills/Preferences:
PMP certification / Applied knowledge of project management processes
Proficient in self-management and organizational skills; able to manage workload, set personal, team priorities, and adjust as needed
Strong interpersonal and teambuilding skills; able to develop effective teamwork between team members with diverse styles
Technical project / system implementation incorporating change management for business adoption
Additional Information:
Travel 0- 10%, depending on location - team presence primarily in Philadelphia, PA and Indianapolis, IN offices
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (******************************************************** for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), en Able (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$115,500 - $187,000
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Auto-ApplyStudy Physician - Oncology (Remote)
Ridgefield, CT jobs
The Study Physician (SP) is a critical role within Clinical Development Oncology (CD Onc) to establish readily available medical support and consultancy for clinical trials within CD Onc by a qualified and clinically experienced physician. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
**Duties & Responsibilities**
+ Responsible for medical content of Clinical Trial Protocols (CTPs), in line with TDO, in collaboration with CTL, CPL, Patient Safety Physician, Medical Writer and other trial and evidence team members to ensure high medical quality CTP.
+ Responsible for medical input into CTP updates.
+ Strong contribution to trial risk-based quality management from medical perspective, by defining medically relevant critical data/processes, related risks, and its mitigation/monitoring strategies in the Integrated Quality and Risk Management Plan (IQRMP) as well as in risk discussions during trial conduct.
+ Medical responsibility as co-author for development of a robust Clinical Quality Monitoring Plan (CQMP) in line with the critical data, medical quality risks and related monitoring/ mitigations identified in IQRMP.
+ Responsible for providing medical input into definition of important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and support trial team in deciding on iPDs from identified potential iPDs.
+ Responsible for execution of relevant clinical quality monitoring for Study Physician using aggregated data outputs as per trial CQMP, timely mitigation & escalation of identified risks & quality issues.
+ Takes medical responsibility for agile & adaptive risk based Clinical Quality Monitoring of critical data.
+ Supports close to real time clinical data medical oversight by using advanced technologies and systems.
+ Proactively addresses/communicates clinical quality issues in a collaborative environment.
+ Contributes to the timely preparation of medically relevant core trial documents and timely milestones.
+ Responsible for medical input into Data Management documentation for the trial, such as eCRF design by efficient translation of medical questions into electronic data capturing.
+ Responsible for "Information for CRF completion" (ICC), Data Review Plan (e.g., propose items such as data screening rules for automated data queries, automated or manual data checks for clinical data consistency), laboratory parameters specifications for the project, Data Transfer Agreement, central laboratory alerts etc.
+ Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, Trial Statistical Analysis Plan (TSAP) etc.
+ Responsible for medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report.
+ Contributes to the medical content of responses to questions from regulators and Ethic Committees/IRBs.
+ Responsible for medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans.
+ Responds to medical queries from Investigators, CROs and/or Sponsor team representatives and contributes to maintenance of trial FAQ log/list.
+ Builds network with experts and active contribution to site engagement.
+ Supports Endpoint Adjudication (EA), Data Monitoring Committee (DMC), Data Safety Monitoring Boards (DSMB) and Steering Committees (SC) (as applicable), by presenting medical content of study to the respective committees, responding to medical questions and by ensuring good quality of data from CQM perspective.
+ Provision of medical training at Country feasibility training, Trial Investigators Meetings or to Sponsor staff.
+ Responsible for medical review of and contribution to the content of Trial Newsletters.
+ Contributes to the scientific publication of trial data (If applicable).
**Requirements**
+ Physician (MD) (ideally with medical thesis), trained in a clinical setting, and minimum of four (4) years of active clinical practice experience; specialization in internal medicine or general practice is desirable. MD in Oncology is preferred.
+ Experience specifically in Oncology Clinical Development is preferred.
+ Experience in pharma industry or CRO in medical or project management functions (ideally in Clinical Development) is desirable
+ Ability to communicate directly and concisely while collaborating with key stakeholders.
+ Pronounced analytical skills and systematic and well-structured working style.
+ Pronounced presentation and training skills.
+ Capability to work proactively and with team spirit in an international environment and team.
+ Displays the ability to use digital technologies to access information, be creative, innovative, solve problems, communicate, navigate, learn & apply in a digital environment.
+ Excellent interpersonal, active listening, influencing skills and fluency in English, both written and spoken.
**Eligibility Requirements** :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
**Compensation**
This position offers a base salary typically between $220,000 and $350,000. The position may be eligible for a role specific variable or performance-based bonus and or other compensation elements. For an overview of our benefits, please click here.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
SR AD/ AD, Principal Clinical Data Scientist -Early Oncology Drug Development (Remote)
Ridgefield, CT jobs
Support the early Oncology clinical drug research and development process by providing strategic planning and execution, including clinical trial design and all aspects of descriptive, diagnostic, predictive and prescriptive analytics of data related to clinical projects like actual trial data, registries and real-world data bases. Represent biostatistics and coordinate the inputs from programing and data management at a substance/asset level regarding data science related aspects. Collaborate with cross-functional teams to design, evaluate, and optimize clinical trial strategies and development scenarios.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
**Duties & Responsibilities**
+ Lead and oversee designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects with established BI experience .
+ Lead and oversee for designing, transforming, analyzing and reporting of other data from research and development like registries and real-world data bases with respect to a specific use case or project/asset.
+ Develop and implement fit-for-purpose statistical designs and Go/NoGo decision frameworks through simulations and scenario planning to ensure high-quality evidence generation.
+ Keep abreast of data science within and outside BI. Apply advanced statistical methodologies and turn derived insights into new data science approaches for early Oncology clinical development.
+ Support fostering innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.
+ Present compelling validated stories regarding complex data science aspects to Biostatistics colleagues and other professionals within and outside of BI.
+ If applicable, supports the clinical drug development process up to the level of substance/assets.
+ Guide and/or lead other colleagues, internal and external customer and external providers on data science related tasks.
+ Coordinate cross-functional working with programming and data management.
+ Be a team player and contribute to cross-functional collaborations.
+ Supports regulatory interactions by ensuring statistical rigor in evidence strategies.
+ Participate in cross-functional BI internal working-groups and drive/plan relevant data science aspects. Participate in external working groups.
+ Liaise with late phase Oncology Biostatistics and Data Science team to leverage synergies and share knowledge.
**SR AD:**
In addition to what is listed above, you will also be responsible for the following:
+ Subject Matter Expert (SME) / Process Lead for designing, transforming, analyzing and reporting complex early Oncology clinical trials or projects, that represent new challenges and for which project and therapeutic knowledge is not given.
+ Subject Matter Expert (SME) / Process Lead for designing as well as transforming, analyzing and reporting of other data that represent new challenges from research and development like registries and real-world databases.
+ Identify trends in data science within and outside BI.
+ Lead cross-functional BI internal working-groups and drive/plan relevant data science aspects.
+ Foster innovative digital approaches to produce sophisticated, intelligent optimization solutions, innovative processes and predictive models.
+ If applicable, supports the clinical drug development process up to the level of Therapeutic Area/assets.
**Requirements**
**AD Requirements:**
+ Bachelor of Science with a minimum of **seven (7) years** ; Or Master of Science with **six (6) years** of experience OR Doctoral Degree (PhD) with **three (3) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.
+ Working experience might be partially compensated by broad and deep topic-specific knowledge.
+ Broad knowledge and advanced experience in software languages relevant for business needs and understanding of clinical trial development process required.
+ Advanced project lead experience required.
+ Understanding and applying key of principles of data science.
+ In-depth understanding of advanced statistical concepts related to Data Science.
+ Demonstrated broad knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex clinical trials, in projects with established BI experience or data from other sources in clinical research and development.
+ Thorough knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.
+ Advanced working knowledge of broad variety of aspects of relevant software languages.
+ Abilitiy to lead and facitlitate meetings as well as develop and deliver trainings related to data science.
+ Language skills: English: fluent (Read/Write/Speak).Know, understand, and implement:
+ International regulations and guidelines for good clinical and statistical practice from all ICH regions,
+ The various international guidelines on clinical development, including statistical methodology, for TA-related disease areas, and
+ BI processes and SOPs that govern clinical development in particular with respect to strategic areas (e.g. Clinical Development Plan).
**SR AD Requirements:**
+ Bachelor of Science with a minimum of **ten (10) years** ; Or Master of Science with **ten (10) years** of experience OR Doctoral Degree (PhD) with **six (6) years,** all must befrom an accredited institution in Statistics, Mathematics, Computer Science or related field (Psychology, Data Science, Finance, etc.). Experience can be from within the pharmaceutical industry, CROs, regulatory authorities or academic institutions.
In addition to what is listed above, the following is required:
+ Demonstrated comprehensive knowledge in planning, transforming, analyzing, interpreting, and reporting data in complex situations that represent new challenges and for which project and therapeutic knowledge is not given.
+ Excellent knowledge of statistical methodology, design of clinical trials or clinical experiments, basic medical terminology and on processing clinical trial information.
+ Advanced understanding of cutting-edge statistical concepts related to Data Science.
+ Comprehensive working knowledge of broad variety of aspects of relevant software languages.
**Desired Skills, Experience and Abilities**
+ Basic medical understanding of Oncology disease areas, including familiarity with clinical endpoints, RECIST criteria, cancer-related terminology, and therapeutic strategies.
+ Familiarity with Oncology translational endpoints (e.g., exploratory or early surrogate markers) and statistical modeling for translational research.
**Compensation:**
This position, AD, Principal Clinical Data Scientist, offers a base salary typically between $140,000.00 and $222,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. (*****************************************************************
**Eligibility Requirements** :
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Executive Director, ExpMed Global Medical Writing - Remote
Ridgefield, CT jobs
**Compensation Data** This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** .
**Description**
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.
The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas.
The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy.
The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization.
**Duties & Responsibilities**
- Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas.
- As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team.
- Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase.
- Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO.
- Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system.
- Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression.
- Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers.
- Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs.
- Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions.
- Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders.
**Requirements**
- Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred.
- 10+ years of professional experience in a scientific, clinical, and/or medical space.
- Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team.
- Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers.
- Experience in (at least passion for) storytelling.
- Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements.
- Demonstrated experience presenting to scientific and non-scientific audiences.
- Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings.
- Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments.
- Expertise in globalizing functions to operate in a standardized fashion.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors.
- Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position
- Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development.
- Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team.
- **Remote*:** this position is considered remote based.
**Eligibility Requirements:**
+ Must be legally authorized to work in the United States without restriction.
+ Must be willing to take a drug test and post-offer physical (if required).
+ Must be 18 years of age or older.
All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
AD, Access & Reimbursement (ADAR) NPS CV -Remote- Las Vegas, NV
Remote
The Associate Director, Access & Reimbursement, NPS (Novartis Patient Support) Cardiovascular, Las Vegas, NV is a remote & field-based role that covers the following, but not limited to: Las Vegas,, NV, Salt Lake City, UT Flagstaff, AZ. Associate must reside within territory, or within a reasonable daily commuting distance of 60 miles from territory border.
The Associate Director, Access & Reimbursement (ADAR) is a field-based role that proactively provides in person (or virtual as needed) education to defined accounts within their assigned geographies on a wide range of access and reimbursement topics and needs (see below) in support of aligned product(s) strategy. ADARs primarily focus on accounts with increased process and workflow complexity, typically including centralized and decentralized systems of care, integrated delivery networks, academic medical institutions, large multi-provider specialty practices, and alternate sites of care.
ADARs will serve as the patient access and reimbursement lead in business-to-business conversations with account executives. The ADAR role is responsible for managing the pull-through of access and reimbursement strategy and downstream operations within their aligned accounts. ADARs are expected to have deep expertise in communicating requirements and addressing barriers associated with local payer policy coverage, multi-channel acquisition pathways, billing and coding education (as needed), claims processing, reimbursement, and integration of manufacturer support programs into a range of account workflows. ADAR will continually need to demonstrate a keen ability to problem solve and manage multiple projects.
ADARs partner closely with other Novartis Pharmaceuticals Corporation (NPC) field associates, including Customer Engagement (Sales) and Market Access, representing NPC with the highest integrity in accordance with NPC Values and Behaviors. ADARs will also be required to coordinate and communicate cross-functionally within NPC (e.g., Patient Support Center, Customer Engagement, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management, and other applicable third party affiliates).
Job Description
Major Accountabilities:
Interact with large, complex accounts to support patient access within their aligned therapeutic area product(s), proactively provide face-to-face education on programs to providers and staff in order to support integration of those products into office processes and workflows.
· Address customer questions for issues related to NPC policies on therapeutic area products ordering, payment, inventorying, and product returns & replacement in offices.
· Work with key members of therapeutic area offices (e.g., executives, providers, administrators, billing and coding staff, claims departments, revenue cycle managers) in order to appropriately support patient access to products.
· Ability to analyze problems and offer solutions. Understand specifics and support questions associated with patient reimbursement and provide support on reimbursement is-sues with third party payers at the provider-level. Analyze account reimbursement issues (as needed). Identifies trends at a local, regional and national level and partner with purpose internally and externally to support patient access to Novartis medicines
· Supports pull through on local coverage decisions to enable meaningful patient access within the system. Proactively communicate policy changes or issues that could potentially affect other departments.
· Accountable for informing customers on NVS-sponsored patient support programs to help enable patients starting and staying on therapy (i.e., Co-pay).
· Maintain expertise in regional and local access landscape, anticipating changes in the healthcare landscape, and act as their aligned therapeutic area product(s) reimbursement expert (as needed).
· Interface with Patient Support Center (hub) and Access & Reimbursement Managers on important matters related to patient case management, including tracking cases, issue resolution, reimbursement support, and appropriate office staff education.
· Collaborate with aligned cross-functional associates within NPC (see above) to share in-sights on customer needs and barriers for their aligned therapeutic area product(s) related to access and reimbursement.
· Maintain a deep understanding of NPC policies and requirements and perform all responsibilities with integrity and in a manner consistent with company guidance and prescribed Values and Behaviors. Handle Patient Identifiable Information (PII) appropriately (under-stand and ensure compliance with HIPAA and other privacy laws and regulations and in-ternal Company compliance guidelines).
· Responsible for identifying and reporting adverse events via the established Novartis systems as per applicable processes.
Buy and Bill Specific
· Assess access situation within the assigned geography and develop appropriate Plan of Action (POA). Communicate POA to appropriate personnel.
· Responsible for educating HCPs using approved materials regarding acquisition path-ways for Novartis products. Educate on buy-and-bill end-to-end processes, workflows, and facility pull-through in complex accounts, including scenarios of centralized and de-centralized acquisition, and use of alternative channels such as white bagging, clear bag-ging, brown bagging, and alternate site of care for administration.
· Educates relevant stakeholders on logistics related to ordering, payment, inventory, and product returns & replacement.
· Analyze reimbursement issues, anticipating changes in the healthcare landscape, and act as the designated reimbursement expert for offices and field teams.
· Accountable for engagement with non-prescribers in regards to Novartis medicines, for example pharmacy, system leadership, financial counselors, office administrators, reve-nue cycle managers, etc.
Key Performance Indicators
• Overall customer satisfaction and awareness related to designated therapeutic area products programs and reimbursement support.
• Education of key customers in therapeutic area offices (i.e. specialists, billing staff, reimbursement staff) in order to assist with therapeutic area products integration and improve patient access in a manner consistent and compliant with company policies and requirements.
• Ensure customers on assigned target list and within assigned geography are aware of and know how to utilize available programs to support therapeutic area products access for patients.
• Adherence with NPC policies, laws and regulations.
Education
Bachelor's Degree required. Business and/or biological science education preferred. Advanced degree preferred.
Minimum Requirements
· 5+ Years of experience in pharmaceuticals / biotech industry focused in Patient Services, Market Access, Sales, and/or account management. With 2 of those years being in a Patient Services practice support role for a specialty product(s).
· Experience working with highly complex practices and/or health systems to establish access and acquisition pathways.
· Strategic account management experience using a proactive approach to anticipate access hurdles impacting accounts and patient access.
· Deep expertise and experience integrating manufacturer-sponsored patient support pro-grams.
· Experience with specialty products acquired through Specialty Pharmacy networks
· Knowledge of reimbursement pathways (specialty pharmacy, buy-and-bill, retail)
· Possess a strong understanding of Commercial payers, Medicare plans and state Medicaid in geographic region.
· Must live within assigned territory.
· Ability to travel and cover geography, at least 50% travel required, based on geography and territory / targeting make up.
· Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated.
· Because driving is an essential function of the role, you must have a fully valid and unre-stricted driver's license to be qualified for this role.
· The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
Preferred Qualifications:
· Experience leading and delivering presentations to C-level account executives.
· Strong ability to work cross functionally with such functions as Field Sales, Marketing, Market Access, Public Affairs, State & Government Affairs, Trade, Specialty Pharmacy Account Management and applicable third-party affiliates.
· Expertise in therapeutic area practice dynamics and common reimbursement and product program support-related needs.
· Strong capabilities in the areas of customer focus, collaboration, business acumen, commu-nication, and presentation skills.
· This position requires significant use of a company provided vehicle and maintaining good driving record
· This is a field-based customer engaging position
· Control business expenses related to field activities (i.e. travel, customer meetings) and pro-vide timely expense reports to manager.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $160,300.00 and $297,700.00/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call *************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$160,300.00 - $297,700.00
Skills Desired
Access And Reimbursement Strategy, Analytical Skill, Analytical Thinking, Cross-Functional Work, Customer-Centric Mindset, Employee Development, Finance, Go-to-Market Strategies, Healthcare Policies, Healthcare Sector Understanding, Health Economics, Health Technology Assessment (HTA), Innovation, Inspirational Leadership, Market Access Strategies, Negotiation, People Management, Process Management, Public Affairs, Real World Evidence (RWE), Regulatory Compliance, Risk Management, Speed and Agility Training (Inactive), Value Propositions, Waterfall Model
Auto-ApplyAD, CART Account Management - New York City Territory - Remote (MD, DE, PA, NJ, Greater NYC)
Remote
Band
Level 5 Experienced managers in a key account management function, responsible for agreed upon targets for the assigned accounts. Primarily responsible for key stakeholder relationships within targeted accounts, develop deep understanding of individual customer needs and identify mutually beneficial solutions for both Novartis and customers through creation and execution of account business plans. Cellular Therapy Strategic Account Manager - New York City Territory - Remote (MD, DE, PA, NJ, Greater NYC)
Please note that this role would not provide relocation and only local candidates will be considered.
Job Description
Major accountabilities:
Responsible for complete ownership of assigned Key Accounts; develop product specific and portfolio strategies in line with goals and customer needs; align Account strategy with other key Sales, Marketing, Patient Access, Medical and Managed Care functions and ensures cross-functional resources and support.
Delivers the Account plans and required financial results for own Key Accounts; works effectively with colleagues in other functions (e.g. Primary Care and Specialty Sales, Marketing etc.) to achieve account sales.
Responsible for contract optimization, access and reimbursement across the specific customer groups that are relevant to the role or business unit.
Leads negotiations, contracting, pull-through and formulary management with assigned Key Accounts -Creates and implements programs designed to build long-term relationships with Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities -Builds and sustains long-term customer partnerships with assigned Key Accounts, based on deep understanding of the customer organization, structure, business strategy and priorities.
Leads cross-functional Account teams and other assigned resources to develop and deliver Account business plans.
Acts as mentor to other Key Account Managers by sharing best practices on contracting, Account plan development and execution and knowledge of product/disease states, customer segments, and healthcare environment and regulations.
Communicates customer insights and Account-related activities to internal stakeholders, and engages with them to pursue business opportunities within assigned Accounts.
Plays a key role in negotations at the regional level and provide strategic inputs and support to the team (as applicable) -May be responsible for leading the tender business and team within the country by coordinating all related activities and stakeholders at local/regional levels -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
Key performance indicators:
Sales revenue and revenue growth in assigned accounts -Portfolio and strategic customer development
Minimum Requirements:
Education:
Bachelor's Degree Required
Experience:
Minimum of 5 years pharmaceutical experience and 3 years of total experience in one or a combination of the following areas: Key Account Management, Reimbursement, Medical Device or sales management required.
Demonstrated record of success in Oncology, Hematology, or Transplantation within an Academic Institutional setting strongly preferred
Proven ability to establish and cultivate key customer relationships
Strong Strategic and Business Acumen skills
Strong negotiating skills
In depth knowledge of healthcare industry, environment and
IDNs/ACOs/Government Accts preferred
NOTE: Above level experience criteria are not an exhaustive list
Skills:
Account Management.
Accountability
Matrixed Collaboration
Commercial Excellence
Competitive Intelligence
Complexity Management
Compliance
Crm (Customer Relationship Management).
Customer Engagement
Enterprise Sales
Ethics
Heathcare Sector
Integrated Marketing.
Market Development.
Problem Solving Skills
Revenue Growth
Sales Strategy.
Selling Skills
Strategic Leadership
Value Propositions
Process Education
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Field roles with a dedicated training period only:
The individual hired for this role will be required to successfully complete certain initial training, including home study, in eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Field roles with a company car: Driving is an essential function of this role, meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions, if an accommodation can be provided without eliminating the essential function of driving.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: **********************************************************
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to ************************ call **************** and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
***************************************************************************************
Salary Range
$160,300.00 - $297,700.00
Skills Desired
5G Technology, Account Management, B2B (Business To Business), Building Constructions, Business-To-Business (B2B) Sales, C (Programming Language), Communication, Customer Care, Customer Experience (CX), Customer Marketing, Customer Relationship Management (CRM), Diversity and Inclusion (D&I), Integrated Marketing, Internet, Key Account Management, Market Development, Small Businesses, Strategic Selling, Windows, Wireless Communications
Auto-Apply