Explore opportunities with Kelsey-Seybold Clinic, part of the Optum family of businesses. Work with one of the nation's leading health care organizations and build your career at one of our 40+ locations throughout Houston. Be part of a team that is nationally recognized for delivering coordinated and accountable care. As a multi-specialty clinic, we offer care from more than 900 medical providers in 65 medical specialties. Take on a rewarding opportunity to help drive higher quality, higher patient satisfaction and lower total costs. Join us and discover the meaning behind Caring. Connecting. Growing together.
Primary Responsibilities:
Join a 30+ radiologist group that is based at our Main Campus location with a possible rotation to an outlying satellite clinic. We are seeking a board-certified radiologist interested in general radiology to include:
Radiography
General fluoroscopy and procedures
Proficiency with interpretation of ultrasound and general body CT preferred.
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications:
Graduate of an approved radiology residency program in the United States.
Licensed in the State of Texas.
Board Certified and/or Board Eligible.
Preferred Qualifications:
Bilingual (English/Spanish) fluency
Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives.
Optum is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
Optum is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.
$128k-227k yearly est. 4d ago
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Body Imaging Radiologist (Remote-or-Onsite)
Kelsey-Seybold Clinic 4.7
Arlington, TX jobs
Explore opportunities with Kelsey-Seybold Clinic, part of the Optum family of businesses. Work with one of the nation's leading health care organizations and build your career at one of our 40+ locations throughout Houston. Be part of a team that is nationally recognized for delivering coordinated and accountable care. As a multi-specialty clinic, we offer care from more than 900 medical providers in 65 medical specialties. Take on a rewarding opportunity to help drive higher quality, higher patient satisfaction and lower total costs. Join us and discover the meaning behind Caring. Connecting. Growing together.
Primary Responsibilities:
Join a 30+ radiologist group that is based at our Main Campus location with a possible rotation to an outlying satellite clinic. We are seeking a board-certified radiologist interested in general radiology to include:
Radiography
General fluoroscopy and procedures
Proficiency with interpretation of ultrasound and general body CT preferred.
You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications:
Graduate of an approved radiology residency program in the United States.
Licensed in the State of Texas.
Board Certified and/or Board Eligible.
Preferred Qualifications:
Bilingual (English/Spanish) fluency
Total cash compensation includes base pay and bonus and is based on several factors including but not limited to local labor markets, education, work experience and may increase over time based on productivity and performance in the role. We comply with all minimum wage laws as applicable. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives.
Optum is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
Optum is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.
$128k-227k yearly est. 4d ago
Inside Sales Representative
Vetoquinol USA 4.0
Atlanta, GA jobs
The Inside Sales Representative is responsible for establishing and maintaining profitable relationships with customers on behalf of the company by taking personal and complete responsibility for each customer contact and by ensuring that all customer requirements are completely met. This position is 100% remote/virtual,
preferably based in the region to which the ISR is assigned.
Essential Functions
Sales and Marketing
Consult with current and potential customers in an assigned geographic area using phone, email, texts, videoconferencing, and other platforms to convert new business, maintain current customers, and grow market share.
Communicate daily with Territory Managers, Regional Manager, Marketing, and other company organizations and external partners as required.
Form long-standing customer relationships with assigned accounts.
Develop and implement sales plans to meet business goals.
Travel occasionally as needed for training, sales meetings, conferences, etc.
Utilize Vetoquinol's Sales Excellence program to engage with customers.
Customer Service
Assist customers in a timely manner.
Manage orders taken by phone, email, or other methods; ensure accurate entry into the Customer Relationship Management (CRM) system and communicate information to distribution partners.
Organize workflow to meet customer and company deadlines.
Present and discuss the products and services of the company in a way that conveys an image of quality, integrity, and superior understanding of customer needs.
Manage inbound and outbound phone calls professionally and efficiently, using good communication skills.
Attend to customer questions, complaints, and concerns immediately, and facilitate satisfactory resolution.
General/Administrative
Document all customer interactions with detailed notes in the CRM system.
Support the company vision and mission, and demonstrate the corporate core values in all professional activities.
Comply with all OSHA safety requirements, work rules, and regulations.
Compile and maintain all required records, documents, etc.
Follow systems and procedures outlined in company manuals.
Communicate out-of-office plans to manager and teammates to ensure uninterrupted customer coverage.
All other duties as requested by management.
Qualifications
Formal Education and Certification
Bachelor's Degree or 3+ years of inside sales experience preferred.
Knowledge and Experience
Inside sales experience highly preferred.
Experience in the animal health industry highly preferred.
Personal Attributes
Exceptional written, verbal, and interpersonal communication skills.
Ability to work under pressure and with shifting priorities.
Team player willing to participate in meetings and other team activities.
Ability to manage time efficiently and to multi-task.
Vetoquinol USA is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and that promotes diversity, inclusion, and fairness. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability. Join us and be a part of a great place to work!
$57k-93k yearly est. 3d ago
Manager, LMS Administration and Operations (Princeton, Hybrid)
Otsuka America Pharmaceutical Inc. 4.9
Phoenix, AZ jobs
The Manager, LMS Operations & Administration position works as part of the U.S. Ethics & Compliance Training & Documentation team to lead all components of our Learning Management System (LMS) including all non-GxP assignments and audience management, curriculum management, reporting, and tier one trouble shooting. The Manager, LMS Operations & Administration will partner with all levels of Management in both business and technology groups to advance and deliver a variety of planned and ad-hoc training initiatives. This position will have direct oversight of two Contracted Workers.
****
+ Responsible for the operational oversight of all LMS activities including but not limited to:
+ Partner with internal LMS Support Team to perform needs assessments and analysis on platform operations to ensure organizational needs are being met. Leads the incorporation, socialization, and training of resulting LMS improvements.
+ Owns all non-GxP LMS usage workflows and processes with business owners for suitability/fit; suggests and implements alternatives as needed
+ Regularly perform reviews of existing training curricula, identify gaps in course assignments and implement necessary changes.
+ Create, maintain, and run scheduled as well as custom reports, in a timely manner, as designated for analysis and decision making. Create new reports as requested.
+ Assist in managing external vendors, suppliers, and internal business partners as needed with a continuous improvement mindset.
+ Partner across departments as necessary to initiate timely and compliant learning initiatives
+ Continually enhance our methods and materials based on best practices in the industry, emerging technologies, vendor resources and products, business unit requirements and expectations, and feedback from customers, trainers and associates.
+ Ensure operational alignment across OAPI/OPDC learning community
+ Develop and deliver LMS platform training when required.
+ Oversee the work of two remote-based contracted resources.
+ Represent Field Training and Development's unique needs at governance and committee meetings/working groups
**Qualifications/ Required**
Knowledge/ Experience and Skills:
+ Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities
+ 5+ years of Learning Management System (LMS) experience
+ Advanced working knowledge of LearnShare LMS
+ Understanding of current approaches in applying technology in learning solutions and experience implementing e-Learning and web-based programs.
+ Strong technical acumen; proficiency in Microsoft Office 365, SCORM; experience with Tin Can/xAPI, LRS's, and general technical troubleshooting
+ Ability to work in a fast-paced environment and be comfortable with consistent change
+ Detail-oriented with strong organizational skills
+ Strong written and verbal communication skills
+ Ability to prioritize and manage multiple responsibilities at once
+ Positive can-do attitude; always willing to learn
+ Strong analytical/technical skills
+ Comfortable with data management/data manipulation
+ Resiliency and tolerance of ambiguity
**Preferred:**
+ Experience in pharmaceuticals/medical devices or other regulated industry
+ Embody a customer service mentality as you communicate and support field sales teams
+ Experience leading Contract Workers remotely
Educational Qualifications
+ Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka 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.
$104.6k yearly 16d ago
Senior Implementation Consultant
Eclinical Solutions 4.4
Remote
eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.
You will make an impact:
As a Senior Implementation Consultant, you will be responsible for liaising with our clients and internal stakeholders to align our client's clinical data strategy to tools and functionality within elluminate.
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare.
Your day to day:
Participate in elluminate implementations by providing business process and product best practices consulting services to support the technical and project management team members
Provide efficient and effective implementation services for clients, by ensuring appropriate requirements gathering through sound assessment of the clients' elluminate environment and expectations
Consult in a post-implementation capacity to measure and drive an increase in the ROI customers receive from elluminate
Steer productive elluminate implementation workshops through a consultative process, administer training sessions, if necessary, and provide high-quality support
Align client clinical data review objectives to functionality in elluminate and delivers gap analysis where applicable
Collaborate with Technical, Engineering, Product, and Project Management team members to develop new and enhanced product offerings in alignment with client objectives; drafts specifications and prototypes as needed
Configure elluminate software to meet the client requirements
Support elluminate training team in preparation of course materials and delivery of courses
Assist sales effort to drive new sales by delivering Proof of Concept, Prototypes/Pilots and targeted presentations that fulfill client expectations
Collaborate with Marketing to develop client specific case studies and share client success
Participate in the development of new processes, best practices, and recommend improvements to all procedures to ensure an optimal level of client satisfaction
Ensure compliance with eClinical Solutions and industry quality standards, guidelines, and procedures
Other duties as assigned
Take the first step towards your dream career. Here is what we are looking for in this role.
Qualifications:
Bachelor's degree or higher preferred, analytic discipline a plus and/or equivalent work experience
5+ years of experience Pharmaceutical/Biotechnology/CRO
Experience in a software development environment a plus
Knowledge of the drug development process and clinical trial execution as they relate to data collection, management, analytics, and reporting
Understanding database concepts and ability to use data to optimize reporting, data mapping and programming
Analytical and technical skills and experience with analytic software applications (i.e., Spotfire, J-Review, Qlik, Tableau)
Prior management and delivery of technical projects in a professional services environment is a plus
Proficiency with clinical data review and analytics solutions required
Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!
eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here: ******************************************************
eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!
We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.
Pay Range
US Pay Ranges $116,000-$145,000 USD
$116k-145k yearly Auto-Apply 15d ago
Senior Program Specialist
Parexel International 4.5
Remote
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Join Our Medical Communications Team at Parexel as a Senior Program Specialist
Are you a seasoned project manager or account manager with experience in medical communications-particularly in publications? We're seeking a Senior Program Specialist to lead the execution of complex, multidisciplinary publication programs while driving excellence across cross-functional teams. This is a full-time, remote position that may require occasional travel.
This is a full time remote position. Candidates need to work out of Canada or the continental United States.
What You'll Do
As a Senior Program Specialist, functioning as a program/project manager you will:
Lead and facilitate program/project kick-off meetings, establishing clear roles, responsibilities, and expectations across internal teams and external stakeholders.
Develop and manage comprehensive project plans, delivery schedules, and tracking systems to ensure timely, high-quality execution.
Maintain proactive communication with clients, faculty, and internal teams, serving as the key point of contact for project status updates and issue resolution.
Monitor budgets, timelines, and deliverables, identifying risks and resolving issues promptly to keep projects on track and within scope.
Collaborate cross-functionally to define project scope, staffing requirements, and implementation strategies, raising concerns and adjusting plans as needed.
Support proposal development and budgeting processes, contributing to program specifications, cost assessments, and implementation planning.
Champion best practices in communication, process efficiency, and team collaboration, continuously identifying opportunities for improvement and innovation.
Ensure alignment with strategic goals and product messaging, working closely with Account Managers/Directors and functional teams to deliver impactful solutions.
What You Bring
Must have 5+ years experience in medical communications project management, (Publications).
Proven ability to lead teams and deliver projects on time and within budget.
Strong organizational, negotiation, and interpersonal communication skills.
Advanced proficiency in Microsoft Word, PowerPoint, Excel, Outlook, and database tools.
iEnvision experience is required.
Familiarity with publication guidelines (e.g. ICMJE).
Bachelor's degree required; Master's preferred in Business or Life Sciences.
Why You'll Love Working Here
Be part of a collaborative and innovative team.
Work on impactful healthcare and scientific programs.
Enjoy a flexible work environment with growth opportunities.
Ready to make a difference?
Apply today and bring your expertise to a team that values excellence, innovation, and collaboration.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$90k-122k yearly est. Auto-Apply 60d+ ago
Oncology Data Specialist, CoC Casefinding & Tumor Conference Coordinator
Mary Bird Perkins Cancer Center 3.2
Baton Rouge, LA jobs
Mary Bird Perkins Cancer Center is Louisiana's leading cancer care organization, caring for more patients each year than any other facility in the region. And with strategic hospital and physician partnerships, we are delivering on our mission to improve survivorship and lessen the burden of cancer.
Mary Bird Perkins and its partners work together to provide state-of-the-art treatments and unparalleled collaborative, comprehensive cancer services. This culture of innovation helps attract the best cancer minds in the country, from expert physicians and highly specialized scientists to forward-thinking leaders in supportive care and other disciplines.
Together, with our hospital and physician partners, we are one-hundred percent focused on cancer care.
Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve.
Job Description:
POSITION TYPE: Full-time, 100% remote. Candidates must have reliable internet access and a suitable remote work environment
SCOPE: This position is required for routine regional registry operations of the Mary Bird Perkins Cancer Center. This pre-ODS-C position is for a candidate who has training in healthcare, medical terminology, and health information coding, which are prerequisites to be trained to become a certified oncology data specialist. Responsible for reviewing cancer registry software messages and initiating reportable cancer cases, performs case abstracting under supervision of a certified oncology data specialist, and coordinates tumor conference meetings.
FUNCTIONS:
1. Casefinding
2. Coordinates Tumor Conference
3. Abstracting, Coding, and Staging
4. Education/Quality Control
5. Productivity
QUALIFICATIONS:
High school diploma or equivalent required.
Associate's degree in an allied health field or post-secondary coursework in human anatomy & physiology highly preferred.
Active ODS-C (Oncology Data Specialist-C) Certification through the NCRA highly preferred.
1-3 years' experience in either regional tumor registry, hospital tumor registry, or applicable healthcare environment.
$49k-81k yearly est. Auto-Apply 21d ago
Site Contract & Budget Lead II
Astellas Pharma 4.9
Northbrook, IL jobs
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Coordination and execution of work within the Site Contract, Budget support function in support of both early and late-stage Clinical Operations and may include support for other functions (Medical Affairs).
This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant regulatory, legal requirement and global data privacy requirements in the support of clinical trial execution that adhere to Astellas and GCP/ICH requirements.
This position will collaborate with Astellas Legal/Data Privacy Organizations, Ethics & Compliance and other external stakeholders as required.
This position will contribute to project level timelines and will report on performance timelines both during feasibility and throughout the lifecycle of contract/budget negotiation.
This position is accountable for the efficient delivery of core and country templates for clinical site operational documents that maintain regulatory and corporate compliance, operational and legal standards, while ensuring contracts are delivered to meet study/project timelines.
This position may be responsible for managing direct reports and may additionally include oversight of contractors.
Responsibilities and Accountabilities:
Responsible for development of final processes, standards and tools for utilization within either both Site Contracts and Site Budget or a specific area of focus (e.g. Site Contract or Site Budget, including global implementation with the project team.
Draft of guidance documentation(s) and training.
Manages the changes of the documents, templates or training under their purview.
Serves as primary liaison to collaborate between business and designated legal partners (as needed) to support development of global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business.
Participates in strategic improvement/innovation projects as requested.
Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies related to these positions.
Support for Industry Best Practice investigation and implementation.
Support for development of related metrics for functional area, including measurement, and monitoring including recommendations to enhance performance of study start up.
Management of any CRO resources necessary for study delivery.
$48k-107k yearly est. 1d ago
Summer Intern - Analytical Data Analyst
Karyopharm Therapeutics 4.4
Newton, MA jobs
Role Overview & Key Functions: If you want to do something that matters, this work matters. Patients drive our passion to pioneer novel cancer therapies. That's why we've built an environment centered around support, flexibility, and a shared mission. Creating and delivering medicine for cancer can only be done through focus, dedication, and heart. We hire exceptional people and trust each other to work in whatever way lets us, be us - whether that's onsite, from home, or anywhere in between.
Our summer intern program, which will run from May 25th - Aug 7th, allows students to gain real world work experience in a high energy, collaborative work culture.
Role Overview & Key functions:
We are seeking a motivated and detail-oriented Analytical Data Analyst Summer Intern to be part of our Analytical team. This internship offers hands-on experience in analytical data analysis, trending, and generating reports/dashboards to support business decision-making. This experience will enhance the Intern's career prospects in Analytical and related fields.
* Transfer data between Smartsheet and excel worksheets/workbooks. Ensuring data integrity and correct formatting in the new destination file.
* Develop complex spreadsheets including creating formulas, functions, PivotTables, Power Query, and data visualization tools to generate reports/dashboards for reporting metrics to be used for annual Quality Management Review (QMR) of XPOVIO products.
* Improve filtering techniques for data queries.
* Participate and collaborate in cross-functional meetings with Quality and Pharmaceutical Sciences to understand data requirements and deliver analytical support.
* Perform administrative tasks related to documentation to standardize formats, ensuring version control and gap assessments for missing values or duplicates as needed.
Candidate Profile & Qualifications
* Enrolled in a full-time pharmaceutical science, or statistical degree program
* Proficiency with Microsoft Office including Word, Excel, PowerPoint, and Teams
* Proficiency with PowerBI, JMP or excel statistical add-on packages a plus
* Strong organization skills with the ability to handle multiple projects simultaneously and effectively
* Strong communication and time management skills capable of working independently and cross-functionally in a remote work environment
* Familiar with data analytics and trending including excel for graphing and hyperlinking source documents
* Analytical or quality control experience in small or large molecules or oral drug products a plus for exposure to different types of data
* Interest in understanding FDA regulatory commitments in commercial programs
* Familiar with cGMP, USP, FDA, and ICH requirements a plus
* You have a strong interest in life sciences and are passionate about giving patients with cancer a chance to enjoy more of life's precious moments.
* You feel a strong connection with our ICARE values (Innovation, Courage, Alignment & Accountability, Resilience, and Energy)
* You demonstrate enthusiasm for learnin
Candidate Profile & Requirements:
* Must be able to complete the Karyopharm Internship Program 27 May - 08 Aug 2025
* Currently enrolled high school or college (bachelor's program) student
* Student must be returning to school in the Fall Term.
* Must have a minimum GPA of 3.0
* Must be highly organized and have the ability to work in independently and collaboratively as a team
* Clear, concise verbal & written communication
Pay for internships ranges from $22 to $30 per hour, depending on the student's academic level (e.g., Bachelor's, Master's) and year in school.
Our Value Proposition:
At Karyopharm, we live and demonstrate our ICARE values every day! Check out our Culture Video!
$22-30 hourly Auto-Apply 9d ago
Executive Director, ExpMed Global Medical Writing
Boehringer Ingelheim 4.6
Remote
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.
$220k-350k yearly 40d ago
Project Leadership - Biotech (clinical trials) - Oncology - Home Based - (Future Needs)
Parexel 4.5
North Carolina jobs
When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve.
Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients.
Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine
Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations
Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director.
To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
$89k-126k yearly est. 5d ago
Senior Field Specialist, Clinical Research (Remote/National Travel)
Cordis 4.2
Irvine, CA jobs
Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.
**Responsibilities**
The **Field Specialist, Clinical Research** position that provides case support to physicians within a given territory. Case support provided on peripheral and coronary interventional procedures in pre-market and post-market phases of product development with SELUTION-SLR. The CFS plays a critical role in clinical studies including device training, case support and ensuring timely data collection for clinical programs.
**Job Functions:**
+ Perform Physician and hospital staff training and procedural case coverage to ensure safe and effective use of the device
+ Present clinical study training materials based on investigational plans including study protocol, IFU, core lab manuals and case report forms
+ Provide field support for clinical studies by participating in site selection, site initiation and activation, supporting cases, ensuring quality data acquisition throughout follow up and performing study closure activities
+ Address clinical research site needs by maintaining frequent contact via email/phone/on-site visits with PI's and research coordinators
+ Responsible for gaining and maintaining knowledge of clinical sites in a given geographical area to best understand and assess investigators interests and capabilities
+ Manage key study sites (investigators and research staff) and serve as 'live' point of contact with the site for communication with SELUTION CSM, CRA, and CRO team
+ Partner with SELUTION clinical research teammates to meet business needs in the field including site CIP questions, re-training, case coverage, data entry/query resolution and escalation of critical issues
+ Administrative activities including evaluating metrics, data entry into trackers, documentation of activities and site feedback to SELUTION study teams
+ Assist with overall successful conduct of assigned clinical studies consistent with applicable regulations, guidelines and policies
+ Identify and mitigate quality risks and issues for assigned clinical studies with oversight from study management team
+ Assist with oversight of activities performed by CRO
+ Maintain in-depth knowledge of current study protocols, process and procedures to assist sites and facilitate study management team efforts
**Role Expectations:**
+ Ability to travel **75%+** within designated geographic territory to facilitate on-site visits to assigned clinical sites
+ Be available to cross-cover sites as back up for other CFS territories, including holding necessary credentialing
+ Attend and lead SIV and site activation activities at assigned sites (in-person priority) for duration of the event
+ Attend start-up phase enrollments and clinical follow up visits at each assigned site to ensure site protocol compliance, image upload and readability and quality data collection
Prioritize regular communication with study management team and CRO
**Qualifications**
Qualifications
+ Ability to travel **75%+** within designated geographic territory
+ Bachelor's Degree in life sciences, nursing, engineering, or healthcare related field (preferred)
+ Minimum 3 years' experience with cardiovascular procedures in clinical research in this same role or as a nurse or tech as radiology tech or Cath lab tech
+ Minimum 3 years' experience working directly with physicians and healthcare professionals
+ Prior experience with clinical trials (preferred)
+ Experience in coronary or peripheral interventions
+ Ability to travel (at least 75%) to company and clinical trial sites
Pay / Compensation
The expected pre-tax pay rate for this position is $76,450 - $145,000 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.
US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.
**Preferred Qualifications**
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one-s identity. All our teammate-s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.
**JOIN OUR TALENT COMMUNITY**
Joining our Talent Community is a great way to receive company news and updates, as well notifications on career opportunities and events that interest you! Please tell us more about yourself so we can align you with future opportunities that match your background, skills and interests.
**Job Locations** _US-CA-Irvine_
**ID** _2025-12332_
**Category** _Clinical_
**Position Type** _Regular Full-Time_
CORDIS is proud to be an equal opportunity employer, values diversity in all its forms is and committed to fostering an inclusive work environment. We are committed to advancing our culture of belonging, where all teammates feel seen, heard, and appreciated and encouraged to be their authentic selves. Our team is invested in attracting, retaining and growing top talent. Our Teammates are the core of our innovation and success. Cordis is an inclusive, engaging place to work and grow a career. CORDIS is committed to offering reasonable accommodations, upon request, to job applicants with disabilities. If you need assistance or an accommodation due to a disability, please contact *******************
$76.5k-145k yearly 27d ago
Patient Enrollment Coordinator (Remote)
Wake Research 3.7
Raleigh, NC jobs
M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance.
Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data.
Due to our continued growth, we are hiring a Patient Enrollment Coordinator at Wake Research, an M3 company. This is a remote role.
The Patient Enrollment Coordinator position is an entry level position within the Patient Enrollment Department at Wake Research and enjoys significant opportunities for career development and growth. The ideal candidate is a highly engaged professional with a positive attitude and growth mindset, who is looking for a long-term career in patient enrollment/study participant recruitment and/or clinical research.
The Patient Enrollment Coordinator has primary responsibility and accountability for the timely enrollment of patients/study participants for all clinical research studies at their assigned site.
Essential Duties and Responsibilities:
Maintain full ownership and accountability for initiating phone contact to potential study participants from all lead sources including internal marketing campaigns, outbound database call lists, EHR/provider practice databases, central campaigns, and community outreach efforts.
Conduct phone-based pre-screening interviews for potential study participants to determine pre-qualification status and eligibility for onsite screening visits.
Provide detailed study information and answer patient inquiries regarding eligibility criteria, study visits and procedures, time commitments, logistics, etc.
Consistently provide outstanding customer service with every patient interaction.
In the case of patient disqualification from initial study of interest, conduct live assessment of patient eligibility for other enrolling or upcoming research studies within appropriate therapeutic areas and conduct additional pre-screening interviews as necessary.
Schedule onsite screening visits for eligible patients within established scheduling guidelines.
Input and record patient information and call notes into CTMS database and other portals and systems in compliance with standardized patient enrollment processes and procedures.
Track information and report data such as call outcomes, limiting factors, etc.; as directed.
Attend and participate in regularly scheduled and ad-hoc patient enrollment and M3 Wake Research staff meetings, as directed.
Maintain compliance with all standardized patient enrollment processes and procedures.
Maintain compliance with HIPAA regulations, FDA, GCP, and IRB guidelines, local regulations, and M3 Wake Research SOPs and Work Instructions.
Qualifications
High school diploma (or equivalent) required. Professional medical certification, associates, or bachelor's degree preferred.
At least 1 year of inbound/outbound call center, phone-based, and/or public-facing customer service experience required. Candidates with transferable skills and strong track records of success in other industries are strongly encouraged to apply.
Previous experience as a medical assistant, nurse or EMT is strongly preferred.
Prior clinical research, healthcare, or medical terminology experience preferred, but not required.
Highly developed skills in communication clarity, accuracy, and attention to detail.
Demonstrated capacity to learn and comprehend new complex information and communicate new knowledge to the public in easy-to-understand terms.
Demonstrated capacity to learn and utilize new software and technology.
Additional Information
About M3:
M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems.
Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements.
Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA.
Benefits:
A career opportunity with M3 Wake Research offers competitive wages, and benefits such as:
401(k), 401(k) matching
Dental insurance
Disability insurance
Employee assistance program
Flexible spending account
Health insurance
Life insurance
Paid time off
Vision insurance
*M3 reserves the right to change this job description to meet the business needs of the organization
#LI-Remote
#LI-LB1
$30k-40k yearly est. 14d ago
Associate Compensation & Benefits Tax Counsel
Johnson & Johnson 4.7
New Brunswick, NJ jobs
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Finance
Job Sub Function:
Tax
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
Johnson & Johnson is seeking an experienced Associate Compensation & Benefits Tax Counsel. This role is located in New Brunswick, New Jersey.
This position reports to the VP Compensation & Benefits Tax Counsel. The candidate will provide high level technical tax and legal advice to management in the administration of the company's worldwide employee compensation and benefit plans.
Incumbent is responsible for ensuring compliance with laws and regulations applicable to employee compensation and benefits. Specifically, incumbent will advise management regarding tax and legal requirements in areas including qualified retirement plans, stock based compensation, employee welfare benefit plans, employee fringe benefits, mergers, acquisitions & divestitures, plan asset investments, and executive compensation matters. The Associate Compensation & Benefits Tax Counsel will also advise on payroll withholding and reporting matters and other global employee compensation and benefits matters.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Position Requirements:
* A Juris doctor degree from an accredited law school is required.
* A minimum of one active state (or District of Columbia) bar admission is required.
* A minimum of 10 years of experience at a law firm, accounting firm and/or major corporation advising clients or management on a wide variety of employee compensation & benefits tax and legal matters is required.
* Working knowledge of the provisions of the Internal Revenue Code applicable to the taxation of employee compensation and benefits and of the Employee Retirement and Security Act of 1974 (ERISA) is required.
* Experience advising on compensation and benefits matters in mergers, acquisition, and divestiture transactions is required.
* Experience advising on plan asset investment matters is required.
* Incumbent will also require excellent business partnering and communication skills - specifically the ability to communicate highly technical matters to management whose knowledge may be more general.
Preferred Requirements/Competencies:
* Exposure to and general knowledge of the laws of some major non-U.S. jurisdictions with respect to employee compensation and benefit matters, reporting and withholding, and employee location compliance are preferred.
The expected base pay range for this position is $173,000 to $300,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program. 6
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
Required Skills:
Preferred Skills:
Agility Jumps, Audit Management, Consulting, Critical Thinking, Fiduciary Liability, Financial Analysis, Financial Reports, Financial Risk Management (FRM), Financial Trends, Leadership, Organizing, Process Optimization, Program Management, Tax Advising, Tax Compliance, Tax Management, Transparency Reporting
The anticipated base pay range for this position is :
173000-300000
Additional Description for Pay Transparency:
$77k-97k yearly est. Auto-Apply 42d ago
Sales Director - Midmarket
New Era Technologies Inc. 3.5
Remote
Join New Era Technology, where
People First
is at the heart of everything we do. With a global team of over 4,500 professionals, we're committed to creating a workplace where everyone feels valued, empowered, and inspired to grow. Our mission is to securely connect people, places, and information with end-to-end technology solutions at scale.
At New Era, you'll join a team-oriented culture that prioritizes your personal and professional development. Work alongside industry-certified experts, access continuous training, and enjoy competitive benefits. Driven by values like Community, Integrity, Agility, and Commitment, we nurture our people to deliver exceptional customer service.
If you want to make an impact in a supportive, growth-oriented environment, New Era is the place for you. Apply today and help us shape the future of work-together.
Great Benefits Including:
Medical
Dental
Vision
401k with a fully vested match
Flexible Time Off (FTO) policy. This reflects our continued commitment to supporting work-life balance, simplifying our time-off programs, and trusting our employees to manage their time responsibly while meeting business needs. No accruals or balances, as time off is not tracked or banked.
5 different Flexible Spending account options
SUMMARY:
New Era Technology Is a trusted global digital systems integration partner, delivering innovative solutions to help clients achieve mission critical business outcomes. We collaborate with our customers across three solution pillars:
Digital Transformation - Enabling organizations to modernize applications, optimize business processes, and leverage data-driven innovation.
Modern Infrastructure & Workspaces - Designing and delivering resilient, scalable infrastructure and empowering employees with secure, productive digital workspaces.
End-to-End Security - Protecting the enterprise across devices, networks, applications, and cloud environments with a comprehensive security approach.
The foundation of our differentiation are the thousands of New Era employees, industry experts, around the globe delivering against our portfolio of global lifecycle services capabilities in:
Field Services
Professional Services
Managed Services
Program Office / Program Services
This integrated services model allows us to deliver consistent, scalable outcomes from planning and deployment through ongoing optimization and support-anywhere in the world.
We deliver innovative solutions to achieve mission critical business outcomes by bringing to bear an eco-system of strategic industry partnerships with the likes of Microsoft, Cisco, and Genesys just to name a few.
The
Sales Director, Mid-market
will be responsible for the performance and development of all sales related activities. The Sales
Director
manages a diverse team of portfolio sellers to provide constant leadership, mentoring and support - aligning sales team objectives with New Era's overall strategy, vision and goals. The Sales
Director
will evaluate and lead existing teams while developing, recruiting and hiring additional talented Account
Executives
to support continued growth. This role is accountable for team performance, pipeline health, territory coverage, and supporting a team culture across the assigned territory and the overall New Era sales organization. The Sales
Director
is a key member of the Mid-market Leadership team and will strive to meet both personal and team goals.
The ideal candidate has experience leading services led portfolio sellers across verticals, geographies, leveraging multiple OEM relationships to deliver outcome-based solutions to clients.
We are seeking a highly motivated, data-driven sales leader who excels at coaching, team development, and GTM execution. Someone who is a self-starter, possesses a strong work ethic, and is committed to the growth & success of New Era and its customers.
HIERARCHY:
The Sales Director, Mid-market reports directly to the Senior Sales Vice President, Mid-market, who reports to the Chief Revenue Officer. The Sales Director will also work closely with the Operational and Finance Leadership across New Era.
PRIMARY DUTIES:
Responsible for the overall management, mentoring, leadership, and strategic development of the sales team.
Lead
Account Executives
across multiple locations - as a single sales team - promoting a high-performance, accountable sales culture.
Implement sales and support strategies, techniques, and tactics based on customer feedback, senior management teams and market environment.
Ensure
Account Executives
are trained to understand and identify opportunities & be able to present all New Era solution offerings.
Responsible for the development of the sales team to include CRM adoption, process improvements, employee skill enhancement, and motivation techniques.
Regularly monitor & communicate sales performance metrics to identify specific areas of improvement for the sales team or individual Account Executive(s).
Coordinate weekly, monthly, and quarterly team sales meetings to review forecasts, discuss strategy and provide training for Sales team, to include product and industry updates, sales strategies, selling skills, etc.
Collaborate with internal business leaders and marketing team to develop sales and marketing collateral for new services and offerings.
Collaborate with and support New Era's Alliances team to leverage manufacturer and distributor relationships to drive sales, while partnering and building relationships to do joint account planning and demand creation.
Collaborates with other local senior managers, regional management and national management to continuously improvement processes and initiatives.
Actively participates in management team functions including offering ideas, insights and recommendations on the presentation of New Era service offerings, new business and other topics that ultimately impact the overall quality of the Company.
Conduct performance reviews, provide frequent feedback, individualized mentoring and address performance issues when necessary.
Ownership and accountability for sales planning, forecasting, and reporting to ensure alignment with regional and national goals.
Work well with and demonstrate respect for colleagues at all levels and consistently contribute to a positive work environment for the entire staff.
Identify wallet-share expansion and new business opportunities, participate in new business pitches and assist in drafting new business proposals.
Maintain relationships with key accounts for direct and/or indirect support and escalation.
Assists in strategic sales efforts as needed.
Leverage existing networks including customers, manufacturers, distributors, consultants, etc. to drive pipeline and sales growth.
Champion a team culture, fostering collaboration, trust, and a customer-centric mindset across the New Era sales organization.
Ensure compliance with all GTM processes, reporting, and cadences.
COMPETENCY:
Superior written and verbal communications skills.
Proficient with Hubspot CRM, Co-Pilot, Microsoft Excel, Word, Power Point, and other productivity tools.
Strong, proven supervisory and employee/team development skills.
Demonstrated ability to lead others in the achievement of business and/or sales targets.
Ability to motivate others and inspire high performance, loyalty, and customer satisfaction.
Strong team work ethic and ability to motivate others to inspire accountable, high performing, collaborative teams.
Strong OEM relationships with New Era Strategic Partners.
Ability to successfully work under pressure, multi-task, prioritize and effectively manage one's time.
Commitment to maintain pace with evolving technologies and products.
Ability to interact at all levels of the organization.
Demonstrated ability to develop and successfully implement strategies.
Ability to pass a comprehensive background screening process.
EXPERIENCE:
At least five years of Technology Industry Sales Management experience, with proven success of meeting / exceeding goals.
Demonstrated success in services-led sales, including Field Services, Professional Services, Managed Services, and Program Services, with the ability to position and sell complex service offerings to executive-level buyers. xperience managing multi-vertical market, multi-technology, multi-manufacturer. environments sales team.
Strong management, coaching, and mentoring skills.
Forecasting sales and pipeline management.
CRM Management.
Experience leading teams remotely across large geographic areas.
Experience working with Mid-market accounts is desirable.
Experience working within state and local government space is desirable.
QUALIFICATIONS:
To perform the job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
REQUIRED EDUCATION: Bachelor's Degree or equivalent experience
LANGUAGE SKILLS: English
PHYSICAL DEMANDS:
Regularly spend long hours sitting and using office equipment and computers.
Regularly use hands and fingers to operate a computer keyboard, mouse and other office equipment.
Regular, repetitive movements such as typing, mouse movements and scrolling. Ability to hear and understand spoken communications, both in person and via remote communication tools (e.g., phone, video conferencing).
Ability to see and read computer screens and printed documents, as well as adjust focus. This includes prolonged periods of looking at a computer screen.
Regularly see details of objects that are less than a few feet away.
Regularly speak clearly so listeners can understand.
Regularly understand the speech of another person.
Frequently work on projects that require deadlines.
WORK ENVIRONMNET: Hybrid work model including New Era offices and client sites within the designated geographic region.
EXPECTED HOURS OF WORK:
Business hours are Monday through Friday 8:00 AM to 5:00 PM. However, required work hours may vary depending on business needs.
TRAVEL: Estimated 50%+ US Based travel required
QUALIFICATIONS:
To perform the job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Other duties, responsibilities and activities may change or be assigned at any time with or without notice.
EEO/AA Statement
New Era Technology provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, national origin, religion, pregnancy, marital status, gender identity, age, physical or mental disability, or covered veteran status.
In addition to federal law requirements, New Era Technology complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
New Era Technology, Inc., and its subsidiaries (“New Era” “we”, “us”, or “our”) in its operating regions worldwide are committed to respecting your privacy and recognize the need for appropriate protection and management of any Personal Data that you may provide us. In this, we are also committed to providing you with a positive experience on our websites and while using our products, services and solutions (“Solutions”).
View our Privacy Policy here *********************************************
We never ask candidates to pay any fees at any point in our hiring process. If you are ever asked to provide payment for training, certification, equipment, or any other purpose, it is not from our company. Only communications from our official company channels should be trusted. Please note our official email domain is @neweratech.com. If you suspect fraudulent activity, please contact us immediately at privacy@neweratech.com .
$95k-172k yearly est. Auto-Apply 1d ago
Ambulatory Service Representative II - Clinic Support
Kelsey-Seybold Clinic 4.7
Remote
Responsibilities
The ASR II is responsible for providing assistance to patients in a friendly and courteous manner. The ASR II is responsible for check-in and check-out functions, including registration and cashiering. The ASR II must maintain a neat and professional appearance and an organized work area.
Job Title: Ambulatory Service Representative II - Clinic Support
Location: Main Campus
Department: Clinic Support
Job Type: Full Time
Salary Range: $39,179 - $48,397 (Pay is based on several factors including but not limited to education, work experience, certifications, etc.)
Qualifications
Education
Required: High School diploma or G.E.D.
Preferred: Associate or bachelor's Degree in related field
Experience
Required: 1+ years of direct face to face customer service experience.
1+ years of cash handling or collections experience.
6 months experience in a customer facing role within a medical office, healthcare setting or other service-
related industry.
OR
1+ years KSC ASR I with 6 months ASR II cross-training experience and the successful completion of Epic Front
Desk Training
OR
1+ years KSC CBO, Managed Care or Contact Center experience.
Preferred: 2+ years of working in a physician, hospital, or medical office environment to include patient
registration, appointment scheduling or medical billing.
2+ years of insurance and /or managed care experience to include insurance verification and the ability to
identify, understand and communicate plan details to patients with HMO, PPO, EPO, Medicare Advantage and
other plans.
1+ years of cash handling or collections experience in a medical office setting.
2+ years of direct face to face customer service experience.
License(s)
Required: N/A
Preferred: N/A
Special Skills
Required: Experience with computers and Windows-based software including Word and Excel. Excellent verbal
and written communication skills. Basic Math ability. Knowledge of customer service principles and practices.
Able to maintain strict confidentiality of all personal/health sensitive information. Ability to effectively handle
challenging situations and to balance multiple priorities.
Preferred: EMR/Epic experience.
Basic calculator skills.
Other
Required: Fluent in English, verbal and written. Professional demeanor, appearance, and grooming.
Preferred: Bilingual- English/Spanish
Working Environment: Office
About Us
Start your career journey and become a part of a community of renowned Healthcare professionals. Kelsey-Seybold Clinic is Houston's fastest growing, multispecialty organization with more than 40 premier locations and over 65 specialties. Our clinics are comprised of more than 600 physicians and as we continue to grow, our focus is providing quality patient care by adding to our team of clinical and non-clinical professionals that work together in a convenient, coordinated, and collaborative manner. Enjoy the rewards of a successful career while maintaining a work/life balance by joining our team today and changing the way health cares.
Why Kelsey-Seybold Clinic?
Medical, Vision, and Dental
Tuition Reimbursement
Company Matching 401K
Employee Reward and Recognition Program
Paid time off for vacation, sick, and holidays
Employee Assistance Program
Continuing Medical Education allowance
$39.2k-48.4k yearly Auto-Apply 60d+ ago
Pork Technical Services Veterinarian
Zoetis 4.9
Remote
will provide technical support for the assigned accounts within Zoetis Pork.
The Pork Technical Services Veterinarian is responsible for providing technical expertise for assigned Strategic Pork Producer Accounts, Veterinary Accounts, and prospect accounts. The Pork Technical Services Veterinarian works with the account manager to help develop a strategic account plan designed to maximize Zoetis sales with assigned account(s). The Pork Technical Services Veterinarian is a leader and trusted business partner responsible for developing intimate knowledge of the Customer's business model.
POSITION RESPONSIBILITIES
The Pork Technical Services field colleague, under general supervision, is responsible for:
Calling on pork producers, veterinarians, dealers, consultants and distributor representatives to provide scientific support so Zoetis may achieve a sustainable competitive advantage.
Providing technical training and education to colleagues within the Zoetis pork business unit.
Providing sound technical advice on routine inquiries, acting as a resource to assist other team members with inquiries.
Providing solutions to a broad array of animal health and production issues that are based upon a sales approach that identifies the customer's needs.
Applying existing veterinary solutions to meet the needs of individual customers based on their needs and promoting a long-term relationship with Zoetis.
Building and maintaining relationships with key industry leaders including veterinarians, nutritionists, extension, university personnel, pork processors and other consultants to our customer base.
Collaborating and building strong partnerships with Area Business Manager(s) to develop and execute the Area Operations Plan.
Partnering with field colleagues to develop appropriate strategies that focus efforts on targeted accounts critical to the success of the business unit or area.
Working with field sales colleagues to create, maintain and execute customer-focused business development plans that clearly identify current and future growth opportunities and allocates expense budget and resources for all high potential customers.
Contributing to team selling efforts by planning call cycles with others to maximize the use of the team's time and resources and ensuring appropriate account follow-up.
Utilizing excellent presentation skills and appropriate tools (e.g. PowerPoint) to conduct educational training on products, programs and services to both internal and external audiences.
Advising and assisting Learning and Development on the technical content of training programs, as required. Providing specialty support to other Areas or businesses as directed by management.
Participating, as required, on special projects and tactical implementation that aligns with key stakeholders to effectively position products and the portfolio (e.g., reviewing sales material, participating on new product launch teams, providing assistance and support to Veterinary Medical Investigations and Product Support and others).
Providing accurate and timely documentation of activities and customer interactions to specified management levels.
Manage STOMP diagnostic budget and timely reporting of diagnostic outcomes to stakeholders.
EDUCATION AND EXPERIENCE
Required Qualifications:
Doctor of Veterinary Medicine degree or equivalent
Two (2) years post-doctoral experience in clinical practice, academia, research or industry
Strong analytical thinking, problem solving skills, and attention to detail
Current in assigned areas of veterinary medicine and pork production management
Strong oral, written, and interpersonal communication skills
Proficient computer skills (MS Office and the ability to learn Zoetis's internal systems)
Preferred Qualifications:
Two (2) years or more private practice experience
Proven record of accomplishments, demonstrating successful veterinary practice management, strategy execution experience and leadership
Ability to exercise good judgment; make thoughtful and fair decisions based on relevant information
Research experience, published scientific papers
Ability to think and act strategically
Extensive knowledge of Zoetis pork products and the animal health industry or ability to learn quickly
Ability to interact with and influence senior management, peers, and other functions
Multilingual, particularly Spanish and English
PHYSICAL POSITION REQUIREMENTS
The position will require a valid driver's license
Willingness to drive to customer locations across the defined geography - Producer, Clinic & Processing Facilities
The US base salary range for this full-time position is $104,000.00 - $168,000.00. Our salary ranges are
determined by role, level, and location. The range displayed on each job posting reflects the base pay target range
for new hire salaries for the position. Within the range, individual pay is determined by work location and additional
factors, including job-related skills, experience, and relevant education or training.
This position is also eligible for long-term incentives
In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional
and the financial well-being of our colleagues and their families, including healthcare and insurance benefits, beginning
on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.
Visit zoetisbenefits.com to learn more
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
$58k-75k yearly est. Auto-Apply 59d ago
Clinical Intern - Pharmacy
Navitus 4.7
Remote
Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $17.78 - USD $20.91 /Hr. STAR Bonus % (At Risk Maximum) 0.00 - Ineligible Work Schedule Description (e.g. M-F 8am to 5pm) M-Th between 8:30am to 7pm and F 8:30am-5pm Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Navitus Health Solutions is seeking a Clinical Intern to join our team! The Clinical Intern will be a key contributor to the success of our Clinical Engagement Center focused on improving member's health and wellness via tele-pharmacy and wellness coaching. Under the supervision of a clinician, this individual is responsible for the delivery of the Medication Therapy Management (MTM) services for commercial and Medicare members. In addition, the Clinical Intern will assist in the development and execution of additional clinical outreach programs to exceed client expectations. The MTM program will include telephonic and/or video chat outreach with members to complete an analysis of a member's medication regimen for prescription, OTC, herbal and supplement medications. The assessment will include the development of a personalized Medication Action Plan in partnership with the member as required by CMS.
Is this you? Find out more below!
Responsibilities
How do I make an impact on my team?
Conduct medication therapy management (MTM) and expanded clinical programs in accordance with the Centers for Medicare & Medicaid Services (CMS).
Develop appropriate clinical algorithms, pathways and call scripts to support pharmacy staff in delivering MTM services.
Review and update all algorithms and call scripts with updated clinical guidelines.
Develop documentation standards for clinical outreach.
Collaborate with other CEC staff to develop and maintain a high quality and consistent MTM product.
Assist CEC leadership to develop programs to support STAR ratings outreach.
Provide clinical outreach to members, prescribers, and pharmacy providers in order to enhance care coordination.
Develop a full understanding of Navitus' Clients' member experience and how the engagement center contributes to improved health and wellness.
Adhere to compliance and HIPAA regulations.
Participate in, adhere to and support compliance and diversity, equity, and inclusion program objectives.
Other duties as assigned
Qualifications
What our team expects from you?
Education:
In DPH-2 or DPH-3 year. CPhT Preferred.
Experience:
Must be 18 years or older.
Experience working in Microsoft Office suite, particularly Word, Excel, and PowerPoint preferred.
The intern role is considered a learning opportunity and as such, no specific experience is required. Preference may be given to candidates with work experience or education paths determined desirable by the department each intern supports.
Participate in, adhere to, and support compliance program objectives.
The ability to consistently interact cooperatively and respectfully with other employees.
Participate in, adhere to, and support compliance program objectives
The ability to consistently interact cooperatively and respectfully with other employees
What can you expect from Navitus?
Top of the industry benefits for Health, Dental, and Vision insurance
20 days paid time off
4 weeks paid parental leave
9 paid holidays
401K company match of up to 5% - No vesting requirement
Adoption Assistance Program
Flexible Spending Account
Educational Assistance Plan and Professional Membership assistance
Referral Bonus Program - up to $750!
#LI-Remote
Location : Address Remote Location : Country US
$17.8-20.9 hourly Auto-Apply 20d ago
Manager Reimbursement Systems Configuration (Telecommute)
Texas Children's Hospital 4.7
Houston, TX jobs
We're hunting for a Manager of Reimbursement Systems Configuration (telecommuter/remote), someone who's ready to be part of the best ranked children's hospital in Texas, and among the best in the nation. In this position, you will be responsible the for the day-to-day Operations of a Production driven team(s), maintaining State and Regulatory requirements along with departmental SLAs. Establishes, implements, and monitors quality control measures. Develops, tracks and reports performance, productivity metrics, proactively identifying trends and refocusing the direction of the team(s). Independently accesses workflows and processes for potential improvements and efficiencies. Works collaboratively with leadership and others from various areas across the health plan to evaluate and work cross functionally to implement new ideas and new strategies.
Think you've got what it takes?
Job Duties & Responsibilities
Manages Business Operations Team
Manage the work and the direction of the team
Direct the Department standards to meet and then exceed any State Requirements
Manages cross function work groups to create and implement best practices across multiple Departments
Report out to Leadership and Executive Leadership with quantifiable metrics on the quality of the data
Define the Department scope and review and sign off on policies and procedures
Educate other departments on provider data use in all systems
Establishes, implements, and monitors quality control measures related to process and/or system changes impacting reimbursement & benefits
Applies regulatory and systems knowledge to ensure regulatory adherence for provider reimbursement
Applies reimbursement, regulatory, payment integrity, and systems functional knowledge to ensure regulatory adherence for provider reimbursement
Quality Management
Coaching and developing
Skills & Requirements
Bachelor's Degree required
Other Medical Coding Certificate preferred
5 years Project management experience required
3 years Management/Leadership experience required
3 years Healthcare industry or MCO environment required
Four (4) years configuration, payment integrity, reimbursement experience can substitute a bachelor's degree
Required skill - prior hands-on experience with configuration (setting up) of the system for one of the following: Provider contracts, Fee Schedules or benefit engine
Required prior management experience
$52k-96k yearly est. Auto-Apply 13d ago
Lead, Regulatory Affairs CMC (Director)
Astellas Pharma 4.9
Northbrook, IL jobs
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at *****************
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
We are seeking an experienced CMC Regulatory Affairs Director with deep expertise in the United States regulatory frameworks and global CMC strategy. This role will lead the development and execution of innovative regulatory strategies for small molecule products (primarily) and biologics or other new modalities (secondary) across all phases of development and commercialization. The ideal candidate will be a recognized thought leader who can influence regulatory policy, drive strategic initiatives, and represent the company in key external forums.
This position plays a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing and Controls (CMC) aspects of regulatory documents and submissions. Responsible for multiple regulatory activities in collaboration with local and global stakeholders (e.g., Product Development & Manufacturing, Regulatory Affairs, Quality Assurance, Business Partners).
Responsible for developing regional/global CMC regulatory strategy (e.g., CMC strategy/planning for new products), driving CMC submission related activities and successfully executing regional/global regulatory strategies in collaboration with local and global stakeholders.
Responsible for supporting business critical interactions inside and outside of Astellas Regulatory Affairs on complex CMC issues and questions in collaboration with local and global stakeholders.
Leads and/or coaches a team or individual team member of regulatory CMC professionals.
The ideal candidate brings deep expertise in designing and executing innovative, accelerated CMC regulatory strategies across oncology and rare disease portfolios. This includes demonstrated experience navigating global expedited pathways such as FDA Breakthrough Therapy, PRIME, Project Orbis, and other rapid-review designations. The candidate will lead the development and implementation of forward-leaning CMC approaches that enable faster patient access while ensuring robust quality, compliance, and lifecycle readiness. Success in this role requires strong strategic acumen, cross-functional leadership, and a proven ability to partner with health authorities to shape regulatory solutions that support program acceleration and long-term product sustainability.
Responsibilities and Accountabilities:
Strategic Leadership:
Define and implement global CMC regulatory strategies with a strong focus on North American requirements.
Provide expert guidance on US FDA regulations, while also ensuring compliance and proactive risk management across major markets including Japan, China, and EU.
Policy & Advocacy:
Represent the company in industry associations, ICH working groups, and industry forums to influence regulatory policy and harmonization efforts.
Monitor evolving regulatory landscapes in the US and other global countries, translating changes into actionable strategies for internal teams.
Cross-Functional Collaboration:
Partner with Product Development & Manufacturing, Quality Assurance and Regulatory Affairs teams to ensure alignment on CMC strategies.
Serve as a scientific and regulatory resource for complex technical issues, enabling science and risk-based solutions.
External Engagement:
Build and maintain strong relationships with FDA, PhRMA, ICH, other regulatory authorities and industry collaborations.
Lead advocacy initiatives for innovative technologies and precedent-setting projects.
Operational Excellence:
Oversee preparation and review of CMC sections for regulatory submissions (IND, NDA, BLA, post-approval changes).
Ensure consistency and quality in dossier preparation across regions.
Expected Key Accountabilities from Global Regulatory Aspects
Acts as CMC regulatory expert and is accountable for recommending global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with regional and global stakeholders to ensure consistency and to identify options for risk discussions.
Member of global teams/task forces which require expert interpretation of applicable EMA/FDA/ICH/Global regulations to ensure CMC compliance within the organization. Sets direction for key operations and new initiatives in collaboration with regional and global stakeholders.
Provides CMC regulatory expertise for New Product Planning and Licensing including during due diligence activities.
Provides oversight on the preparation and review of complex global registration packages to ensure effective data presentation and quality scientific data against applicable regulatory requirements. In collaboration with regional and global stakeholders, determines the best way to present information in assigned regulatory submissions to maximize reviewability by global health authorities. Defines and implements regulatory strategies and priorities for; global registrations, supplemental submissions/variations, response documents to health authority questions including Agency meeting planning and preparation, and global change control issues in collaboration with local and global stakeholders.
Reviews global regulatory submissions for consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and marketing authorization registration filings and DMFs.
Actively seeks out knowledge of overall corporate/global strategy and other general factors that affect the regulatory positions taken within the company, and with global health authorities, and incorporates this knowledge in interactions with others. Will also impact global strategy directly by participating in strategic planning in therapeutic area and with global stakeholders for chemistry, manufacturing and controls aspects.
Provides regulatory guidance for compendial issues (Ph.Eur., USP and JP etc.) and monograph preparation.
Provides support to the CMC RA Modality Head to develop an environment to enable CMC RA professionals to optimally operate in the matrix environment of RA, R&D, Product Development & Manufacturing within Astellas.
Leads and/or coach a small team or individual team member of (regulatory) CMC professionals, provides training.
Interacts with executive level on routine and serious matters; internally and externally to influence policy and strategy; with development partners; with global health authorities at review, management and senior staff, including negotiations on controversial areas. Established rapport with global health authorities that enables constructive exploratory discussions.
Facilitator role in health authority meetings. Works on complex and diverse problems with decision making that has functional or corporate impact. Actions may have serious implications for operations, revenue, and/or credibility.