- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …leadership while driving results.Collaborate with internal and external stakeholdersInteract with senior CSPV/ Medical Affairs leadership teams to ensure Quality ... centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to...key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. ... with the VP Medical/Scientific Development, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams… more
- Eisai, Inc (Nutley, NJ)
- …hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics mainly for GU therapeutic area. This ... working with key stakeholders to develop and execute the medical affairs plan, including data generations (including RWE), post-marketing research, medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . Relationships The Senior Medical Writer reports to a Director of ... personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and Non-clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III clinical… more
- Tris Pharma (Monmouth Junction, NJ)
- …experienced MD with expertise in the Pain therapeutic area to serve as Senior or Executive Medical Director. Title and salary commensurate with experience. The ... Executive/ Senior Medical Director provides leadership, direction and medical expertise...programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD, etc.); Designs… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program . The...and global project teams. This role will be a senior member of the Regulatory , Quality and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science...(CS) Group Lead will be responsible for overseeing multiple program -level CS Asset Leads who are managing a team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and will work regularly with all business areas (Sales, Marketing, Clinical, TMPC, Med Affairs , and Regulatory Affairs ) and support functions (IT, Finance, ... responsible for creating and assisting in the development of compliance program trainings and communications, including developing eLearning modules. This position… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional teams, including analytics, therapeutic area marketing leads, sales, medical affairs , market access and policy/advocacy (MAPA), and channel leads to ... profitability and understands return on investment (ROI) concepts to ensure program effectiveness Data-Driven Insights and Optimizations: Within the HCP experience… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... reinforcement and ongoing growth of our culture. This position will report to the Senior Director, HCP and Payer Lead. This position does not have any direct… more
- Baystate Health (Springfield, MA)
- …Health, including all licensed sites. The Senior Director, Regulatory Affairs develops a comprehensive accreditation program to ensure: 1) BH complies ... Under the direction of the Chief Quality Officer, the Senior Director, Regulatory Affairs directs the strategic management and planning for the Joint… more
- Veterans Affairs, Veterans Health Administration (Memphis, TN)
- …large health care system. Provides feedback to senior management on public affairs trends and stakeholder attitudes to assess program effectiveness and make ... are not limited to: Experience designing, planning, and executing a public affairs program . Knowledge of graphic, audiovisual, and photographic theories,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the ... pertain primarily to marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs , in collaboration with Head,… more
- STERIS (St. Paul, MN)
- …required documents. Utilizes electronic record-keeping tools according to departmental policy. The Senior Regulatory Affairs Manager is expected to have ... Senior Manager, International Regulatory Affairs...401k plan. Employees are covered by an employee assistance program (also available to household members) and long-term disability.… more
- GE Vernova (Wilmington, NC)
- **Job Description Summary** The US Senior Licensing Engineer, Regulatory Affairs , based in the US, will complete various regulatory work scopes in the US ... teams on major projects. **Job Description** **Roles and Responsibilities** + As the US Senior Licensing Engineer, Regulatory Affairs , you will perform the… more
- Magna (Troy, MI)
- Senior Manager, Regulatory Affairs ...Data Access + Safety Labeling (eg, New Car Assessment Program ) + Measure and report on the effectiveness of ... on this journey. **Role Summary** **About the Role:** The Senior Manager, Regulatory Affairs assists...(k) plan with employer matching + An extensive training program and exciting internal development opportunities + Cafe +… more
- Stryker (Fremont, CA)
- …about our award-winning organization by visiting stryker.com We are currently seeking a ** Senior Staff Regulatory Affairs Specialist** to join our ... Great desire to learn and looks to continuously improve. **What you will do** As the ** Senior Staff Regulatory Affairs Specialist** , you will be core team… more
- STERIS (Mentor, OH)
- Senior Regulatory Affairs Specialist Req ID: 44311 Job Category: Regulatory Affairs Mentor, OH, US, 44060 Description: At STERIS, we help our ... the globe. Position Summary The mission of the STERIS Regulatory Affairs function is to standardize and...activities that impact business in the Canadian market, updating senior leaders on key regulatory developments that… more
- Catalent Pharma Solutions (Bloomington, IN)
- **We're hiring for a Senior Regulatory Affairs Specialist to support compliance and regulatory affairs in Bloomington, Indiana!** Catalent is a ... mission: to help people live better, healthier lives. The ** Senior Regulatory Affairs Specialist** serves...+ Competitive salary with bonus potential. + Tuition reimbursement program . + Diverse, inclusive culture. + Generous 401K match.… more
