- Daiichi Sankyo, Inc. (Bernards, NJ)
- …across all Medical Affairs programs. This role involves deputizing for the Sr . Director, representing the Quality organization at senior levels. The Director ... and working toward building a quality mindset with Medical Affairs .Support the Sr . Director's Medical Affairs Quality strategy by partnering with members… more
- Insmed Incorporated (San Diego, CA)
- … Affairs , lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product developmentMonitor ... for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader… more
- Merck & Co. (North Wales, PA)
- …acumen and expertise in data and data standards across Clinical Development, Medical Affairs , and Regulatory Affairs domains. Apply domain knowledge to ... Clinical Development and Digital Solutions (CDDS) value team, - the Business Strategy Partnership (BSP) organization is seeking a highly motivated Senior … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … impact including execution, leading and lagging metrics that tie to the medical affairs strategy . Update the metrics in a regular cadence based on feedback ... from HCP interactions, patient outcomes and evolution of medical affairs strategy .- Pilot Analytics projects: Evaluate technologies and platforms that support a… more
- Merck & Co. (Rahway, NJ)
- …innovation and leveraging it for how we operationalize CMC. This individual will be a senior member of the Regulatory Affairs CMC organization and will also ... lead a team of CMC professionals, ensuring rigorous CMC regulatory strategy and delivery of high-quality submissions...strategy , risk, mitigation, and overall plan to the Regulatory Affairs , R&D, Manufacturing and GHH management… more
- Merck & Co. (Upper Gwynedd, PA)
- …--Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... Management Process, Medical Research, Mentorship, Plan of Action and Milestones (POA&M), Regulatory Affairs Compliance, Regulatory Compliance {+ 5… more
- Merck & Co. (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx ... primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Merck & Co. (Rahway, NJ)
- …, Multiple Therapeutic Areas, People Leadership, Pharmaceutical Medical Affairs , Relationship Building, Scientific Communications, Scientific Exchange, Strategic ... Job DescriptionThe Regional Medical Scientific Senior Director - Team Lead (RMSD TL) is a credentialed therapeutic and disease expert (MD, PhD, PharmD, DNP, or DO)… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Senior Manager, PCP Marketing, will lead the development and implementation of primary care ... Functions /Key Responsibilities: Assist the development of the PCP go-to-market strategy Partner closely with cross-functional teams to develop and execute all… more
- Merck & Co. (Millsboro, DE)
- …SOPs, Quality Notifications and technical documentation; collaborate cross-functionally with QA, Regulatory Affairs , EHS, Engineering, BTS, ATS and HR.Direct ... Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated...safety, delivery, cost of goods, and budget forecasts.Translate site strategy into IPT annual plans and priorities (hoshin kanri… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …Washington, DC. **This position does not offer relocation assistance** **About the role:** The Senior Regulatory Affairs Strategy Specialist will work in ... Affairs at BD Explore innovative solutions in BD Central Regulatory Affairs (RA) - Regulatory Strategy Team. Develop expertise across medical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory ... product development activities/meetings + Perform research to support the development of regulatory strategy for the assigned clinical development program +… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular ... impact of decisions across functional areas. As a strategic leader within the Regulatory Affairs organization the incumbent will be instrumental in the evolution… more
- Sumitomo Pharma (Nashville, TN)
- …CNS assets. **Job Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain approval for ... and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads... regulatory strategy to meet the Company's objectives. + Oversee the… more
- ThermoFisher Scientific (Grand Island, NY)
- …Good Manufacturing Practices (GMP) Safety Standards, Office **Job Description** The Sr . Manager, Regulatory Affairs - Drug Support Strategy is a new role ... collaborate with and lead all aspects of professionals in regulatory affairs to develop detailed drug support...strategies, as well as customer and employee needs. The Sr . Manager will develop and pursue world-class regulatory… more
- FirstEnergy (Columbus, OH)
- …initiatives that are important to the company and/or its stakeholders. + Partner with Regulatory Affairs on statewide strategy and positions. + Prepare ... as needed, less than 20% of the time. The Sr . Advisor, State Government Affairs - Ohio...technology resources. + Advanced administrative principles and skills, including strategy development and analysis. + Strong planning and project… more
- Clean Harbors (Norwell, MA)
- …disciplinary actions, and performance evaluations related to health and safety compliance. **Government Affairs & Regulatory Strategy ** + Monitor, track, and ... in two key areas: environmental and facility compliance, and government and regulatory affairs . This executive leader ensures operational alignment with… more
- Danaher Corporation (Deer Park, IL)
- …which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for regulatory strategy development and execution ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...with BioPharma partners on key projects, engaging with global regulatory agencies, and steering regulatory strategy… more
- Medtronic (Lafayette, CO)
- …professional development to build a high-performing and scalable organization. Mentor and coach senior regulatory affairs managers to enhance their skills ... with a track record of building and managing high-performing teams and departmental strategy . ** Regulatory Affairs :** Deep and comprehensive knowledge of the… more
