Boehringer Ingelheim 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.

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.

The U.S. Oncology business within our company is a growing and dynamic part of our company. We have an exciting opportunity to join our dynamic marketing team focusing on intismeran autogene, a cutting-edge individualized neoantigen therapy (INT), which represents a transformative approach to cancer treatment, as part of our alliance partnership. We are seeking a **Director, US Oncology Marketing, INT Treatment Site Strategy & Execution Lead** . This role will be pivotal in the development and execution of innovative strategic commercial plans to support the seamless **end-to-end patient journey** for intismeran autogene. This process begins with the acquisition of patient tumor and blood samples, genetic sequencing of the samples, customized manufacturing of the individualized therapy and subsequent delivery back to the health care provider for administration to the patient in combination with our immuno-oncology product. This role will also drive the strategy to develop the treatment site network and site readiness for the launch of intismeran autogene. This position will report to the **Executive Director, U.S. Oncology Marketing, Intismeran Autogene/Alliance** **Lead** and work cross-functionally with multiple teams across the organization to support the launch of this innovative therapy. **Key Responsibilities** : + Develop and implement orchestration systems and processes to support the seamless end-to-end patient journey at treatment sites and ensure alignment with several cross functional teams that are involved in intismeran autogene treatment process, including but not limited to global orchestration lead, manufacturing, supply chain, IT, legal/compliance, market access, marketing, precision medicine, and field commercial. + Lead and develop the treatment network strategy to identify intismeran autogene treatment sites, site readiness strategy to integrate INT operations into treatment sites, and address potential operational bottlenecks at sites, ensuring a smooth commercial ordering experience. + Provide guidance and input for the development of the customer-facing INT orchestration software based on US market strategic needs and customer insights. + Collaborate closely with the Precision Medicine team to facilitate a smooth patient tumor and blood sample collection process, securing a seamless path to therapy manufacturing. + Enable the development and execution of the customer-facing field role strategy, focused on designing an effective field customer engagement model that aligns with unique business needs for intismeran autogene, including treatment site readiness and INT operational needs. + Identify strengths and risks to customer experience in the end-to-end patient journey. Develop and implement risk-mitigation strategies and enhancement features to support optimal customer experience with INT. + Research and implement industry best practices, identifying potential risks and gaps specific for INT, based on insights from similar individualized complex therapies (e.g. cell therapy, gene therapy, radioligand therapy). **Required:** + Bachelor's Degree + Minimum of 8 years pharmaceutical business experience, including marketing, sales, and/or operations + Excellent project planning & management skills; strong analytical and problem-solving skills + Demonstrated track record of operational excellence, with comprehensive knowledge of commercial and/or clinical operations + In-depth understanding of healthcare hospital systems and community oncology practice operations. + Strong business acumen and ability to drive forward key initiatives in a fast-paced environment. Proven ability to drive execution across multiple cross-functional teams + Exceptional collaboration skills, both within commercial teams and cross divisional teams + Proven leadership skills with ability to influence without direct authority, navigating complex organizational structures **Preferred:** + Advanced degree in a relevant field + Demonstrated track record of operational excellence, with comprehensive knowledge of commercial and/or clinical operations + Broad cross-functional experience within the pharmaceutical industry, including exposure to teams in manufacturing, supply chain, IT, finance, and business planning + Expertise in process improvement, with a strong background in methodologies such as Lean Six Sigma + Demonstrated ability to embrace a flexible, growth-oriented mindset + People management experience with a track record of managing and developing high-performing teams + Proven ability to manage strategic alliance partnerships **Location** : Upper Gwynedd, PA, Rahway, NJ OR Remotely located **Required Skills:** Business Management, Communication, Customer Engagement, Data Analysis, Decision Making, Digital Marketing Campaigns, Gene Therapy, Healthcare Personnel (HCP) Marketing, Innovation, Leadership, Oncology Marketing, Risk Mitigation Strategies, Strategic Product Planning, Strategic Thinking, Team Management **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $187,000.00 - $294,400.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, 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. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 25% **Flexible Work Arrangements:** Remote **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** NA **Job Posting End Date:** 01/6/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R376296

#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

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

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.

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.

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

Director OR Senior Associate Director has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on a global level. In additional to reporting to US line management, this position may matrix reports to a Lead Patient Safety 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 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** + Develop or support proactive risk management strategies for assigned key marketed and/or investigational compounds. + Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including: + Chair or support the BI-internal Asset Benefit Risk Team, consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate + Depending on the status of development of the compound, may be required to lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound or product including project-specific training and coaching of team members, review of team output. + Provide updates of the assigned drug´s safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV. + Represent PSPV in internal and external committees & bodies. + Contribute to the further development of pharmacovigilance within BI by staying abreast of state of the art methodology, changes in the regulatory environment and developments and trends in healthcare system and society + Contribute to strategic projects within PSPV (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment). + In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that require Patient Safety support. May serve as liaison from team to VP, PSPV-US and provide regular updates to US teams and leadership as needed. + Represent PSPV during global health authority interactions. **Requirements** + US MD or DO degree or international equivalent from an accredited institution required. + In addition, the following are strongly preferred: + Completion of a US residency or ex-US equivalent. + Active or inactive US license to practice medicine, or international equivalent. + Board certification / experience in a medicine subspecialty would be an asset. + People leadership potential required. Senior Associate Director: + Total applicable experience (incl. clinical practice, plus research or relevant industry) of greater than three (3) years required. Director: + Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (5) years, and a minimum of two (2) years of experience in the pharmaceutical industry or equivalent (preferably pharmacovigilance) required. + One to three (1-3) years of leadership experience (e.g. projects, teams, initiative) and influencing teams required. Additional: + Excellent interpersonal and communication skills (both written and oral) required. + Ability to attend key meetings in person required. + Highly ethical personality putting patient safety first. + Self-starter and driving personality, willingness to take on responsibilities. + Sound medical-scientific and clinical knowledge and judgement. + Ability to synthesize large amounts of medical data, draw medical conclusions, and clearly communicate the conclusions. + Good understanding (based on experience) of Pharmacovigilance and Risk Management in a major pharmaceutical company on a global / corporate level, including safety in clinical development and post-marketing safety. + Understanding of pharmacovigilance regulation in major markets and respective need for compliance. **Compensation** This position offers a base salary typically between $220,000 and $394,000. 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.

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us. This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role: At MilliporeSigma, as the Manufacturing Supervisor you are responsible for the supervision of a group of operators for the commercial GMP production on site. This site works with the gas distillation process to produce chemical products for commercial use. Develop team members knowledge and skills to improve performance and expand abilities. Coordinate the group's efforts to assist meeting department and company objectives. Schedule tasks and processes to meet department and company objectives, which include scheduling personnel, equipment, and ordering raw materials. Maintain awareness of general area operations to ensure that resources (personnel and facility/equipment) are used towards maximizing our overall effectiveness. Providing assistance and guidance. Prioritize and delegate critical tasks according to the impact on the project/process and compliance. Enhance the knowledge and capacity for GMP operations across the site's team. Who You Are Minimum Qualifications: Bachelor's Degree in a science discipline (e.g., Chemistry, Chemical Engineering, Biochemistry, etc. ) 3+ years of GMP related experience in the chemical, speciality chemical and/or pharmaceutical industry Preferred Qualifications: 2+ years Supervisory experience. Demonstrated experience leading, training and/or motivating people. Project management, planning and scheduling experience. Experience using SAP. Strong leadership, problem-solving skills, and organizational ability. Effective communicator, both written and verbal, across all levels of the organization. Strong technical skills - ability to interpret and evaluate information regarding the processes. Thorough understanding of Quality System Regulations (e.g., 21 CFR Part 211 and ICH Q7) Good computer and data analysis skills, including proficiency in MS Word, Excel, and Access. Pay Range for this position - $86,600k - $130,000k The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!

**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.

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

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

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

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.

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.

The Cardiovascular-Renal Sales Consultant is responsible for partnering in developing and implementing a plan for brand sales growth of BIPI and co-promoted cardio-renal-metabolic (CRM) products that aligns with direction from BIPI commercial leadership and with BIPI guidelines, policies, and directives. The Cardiovascular-Renal Sales Consultant will conduct their business with key targeted healthcare providers (Cardiology specialists/Nephrology specialists/Advanced Practice Clinicians and Allied Healthcare Professionals). The consultant will have additional responsibilities for sales activities in teaching and community hospitals, federal and military hospitals, heart failure clinics, managed health care facilities, and integrated delivery networks, etc. utilizing in-person and/or digital/virtual platforms. The CR consultant is also responsible for generating advocacy for BI products with Key Decision Makers in the hospital accounts they are responsible for. 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 Executes brand strategies to ensure that company sales and marketing messages are delivered appropriately to customers. Leverages knowledge of cardiology, nephrology, diabetes, and the marketplace to anticipate and effectively manage business opportunities and challenges. Demonstrates knowledge of the disease state, key drivers, influencers, and prescribing patterns in territory. Establishes and maintains effective communication/cooperation/coordination with co-promotion partners and BIPI employees. Works effectively with all customer-facing roles (i.e.. account teams, medical teams, etc.) in each geography to meet customer needs and deliver net sales objectives. Demonstrates knowledge of BIPI cardio-renal-metabolic (CRM) products and related marketplace, effective translation of product knowledge into the sales presentation and is customer focused with a priority directed towards providing solutions-based customer interactions. Delivers high level of clinical and technical value to his/her customers, assisting the health care customer in meeting their unique patient care needs, all within BI regulatory guidelines. As a trusted CR Consultant, encourages and receives requests from customers for technical information outside of standard visits. Through all these endeavors, develops trust and subsequent value with customers. Drives appropriate utilization of approved Cardiovascular-Renal products. Uses appropriate BIPI Sales Training techniques to facilitate the customer decision making process. CR Consultant works closely with other commercial associates to generate pull-through within local payers, hospitals, community Health Care Providers. Fosters cardio-renal customer network development and communication. Coordinates the engagement of healthcare providers through a range of personal and non-personal channels, according to customer preferences. The CR consultant must demonstrate the ability to engage with customers through a variety of digital media and platforms (live, remote video conference, marketing email etc.) and integrate digital assets and strategies into broader territory-level business plans. Delivers on "continuation of care" model, including discharge protocol, treatment algorithms, disease management, etc. Supports the efforts in various care settings to include appropriate pull through of protocols, pathways, order sets, formularies, treatment algorithms, transition of care, and population health management initiatives to assist with the delivery of optimal care. Requirements This is a dual level posting. Candidates will be hired at the level commensurate with their experience and business need. Cardiovascular-Renal Sales Consultant Requirements: Bachelor's degree preferred. At least three (3) years of experience in pharmaceutical sales of which one-plus (1+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. Hospital and/or Account Management experience preferred. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. Executive Cardiovascular-Renal Sales Consultant I Requirements: Bachelor's degree preferred. At least five (5) years of experience in pharmaceutical sales of which two-plus (2+) years of experience in the promotion of cardiovascular and/or diabetes and/or nephrology pharmaceuticals. At least one-plus (1+) Hospital and/or Account Management experience required. History of successful performance. Meets expectations for the key competencies required for this role. Proficiency in Excel, Word, Outlook, and database applications. Ability to travel (may include overnight travel). Should reside in territory geography or be willing to relocate. Valid driver's license and an acceptable driving record. Authorization and ability to drive a company leased vehicle or authorized rental vehicle. 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 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.

In the role of Director of Business Development & Key Account Management (BD&KAM) you will primarily execute on the contract manufacturing business strategy of Boehringer Ingelheim BioXcellence, with focus on Mammalian Technology in the US market. You will drive the mammalian customer and product portfolio refreshment and expansion by screening, developing, and managing new accounts in the mammalian arena from a defined US territory. Moreover, you will represent the business externally at global conferences and events via direct company contacts. 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. **Requirements** + Requires a minimum of a Bachelor´s Degree in Business or Science / Engineering; advanced degrees or MBA preferred. + Requires a minimum of eight (8) years´ experience in new business development and / or sales and marketing within Pharmaceutical or related industry preferred. + Must have Biologics and / or US governmental CMO Industry experience. + Four (4) to six (6) years project management experience + Must have excellent communication skills (written and oral communication incl. public speaking and presentation skills) + Excellent analytical skills + Strong interpersonal skills + Comfortable working in a fast paced, emerging market segment + Innovative thinker (´out of the box´) with strong creative skills + Entrepreneurial drive + Financial skills + Physical Demands / Surroundings - Works in an office setting under desirable conditions with few or no disagreeable features. Duties do not require incumbent to exert physical effort beyond normal office conditions. Some domestic and international travel may be required. + Visual Demands - Must be able to read and see clearly. Vision clarity with or without correction to read handwritten as well as computer generated documents. + Attendance / Schedule - Attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager. + Will require frequent travel as needed to serve the needs of the client and meet with key counterparts within the BI network. + Desired Experience, Skills and Abilities: + Extensive and up-to-date knowledge of US Biopharma market, pharmaceutical industry, regulations and competitor companies / brands + Proven record in identifying and capitalizing on market opportunities to drive revenue and growth + Experience in working with multi-cultural interdisciplinary teams + Additional know-how in finance and marketing desirable + Existing network among peers in other national and international pharmaceutical companies **Desired Skills:** + PhD/Master's degree with at least 5 years' experience in the (bio)pharmaceutical industry in a business function, or in technical operations preferred biomanufacturing. + Understanding of the Biotech/Pharma market, products, players, and technologies is a Must. + Strong business acumen, solid financial, analytical, and problem-solving skills. + Strong communication and presentation skills and excellent command of English (verbally and written). + Must-haves are strong networking and relationship skills with clear account focus. + Willingness to travel internationally, around 40%. **Duties & Responsibilities** This role is working in a global BDKAM & Marketing team closely together with other BioXcellence Functions and the global Biopharma network. + You will scout and screen potential new potential US customers and products involving high level of company contact and extensive networking across various channels. + As a Business Development & Key Account Manager, you are the primary contact for new and established accounts. You will lead through the BioXcellence acquisition process. + You will also serve as an Account Manager for selected accounts and products by leading account business teams. + In general, you manage account relationships, understand their needs and act as account ambassador towards the internal organization. **Compensation Data** This position offers a base salary typically between (200,000) and (316,000). There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skills. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. Please reach out Talent Acquisition or your HR Business Partner for more information. 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.