- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director , Global Oncology Medical Affairs , Medical Analytics ... of related experience working in data analytics in commercial, regulatory , market access or medical affairs function in a healthcare industry required- 4 or More… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the ... (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk integration to… 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 ... trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and...strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs,… more
- Ascendis Pharma (Princeton, NJ)
- …and committed to working together as one team to achieve extraordinary results. The Associate Director Regulatory Affairs , Advertising and Promotion will ... trends governing the promotion of prescription drug and biologic products. The Associate Director Regulatory Affairs , Advertising and Promotion is… more
- Sumitomo Pharma (Trenton, NJ)
- …currently seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director , Regulatory Affairs (Oncology).** The ... Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily function as a regional regulatory leader… more
- United Therapeutics (Trenton, NJ)
- …or pharma regulatory experience with a Bachelor's Degree in life sciences, quality, regulatory affairs or a related area of study or 10+ years of biologic ... pharma regulatory experience with a Master's Degree in life sciences, quality, regulatory affairs or a related area of study or 7+ years of biologic or… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: Regulatory expert in the area of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject ... and company goals and objectives. Essential Functions: + Develop and Execute Global Regulatory Strategies: Formulate and lead global CMC and clinical regulatory … more
- Bristol Myers Squibb (Princeton, NJ)
- …brings an expertise in regulatory affairs and related policy. The Associate Director , Regulatory Policy is responsible for driving regulatory ... careers.bms.com/working-with-us . **Job Purpose:** This position is focused on regulatory policy to ensure appropriate and effective regulatory...team, the Associate Director Regulatory Policy… more
- J&J Family of Companies (Titusville, NJ)
- …America, Titusville, New Jersey, United States of America **Job Description:** **Senior Manager/ Associate Director , Regulatory Medical Writing X-TA** At ... We are searching for the best talent for a **Senior Manager** **/ Associate Director ** , ** Regulatory Medical Writing** within our… more
- J&J Family of Companies (Raritan, NJ)
- …and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory ... a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a hybrid… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director , Head, ICSR ... create Corrective Action and Preventative action (CAPA) as applicable. + Oversee regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position ... PhD, PharmD, BSN, etc.) with at least 3+ years of Regulatory Affairs experience in the pharmaceutical industry. **Key Competency Requirements** + Understanding… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- ** Associate Director , Small Molecule Analytical Development** + Lead and oversee phase appropriate method development and optimization for drug substance and ... cross-functionally with analytical team members, process chemistry, formulation development, regulatory affairs , quality assurance, and other departments to… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical Neuropsychiatry position works in the US ... manage integration points across US functional and commercialization areas to ensure alignment. The Associate Director will report to the Senior Director , US… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …data scientists and data programmers, and external stakeholders including Medical Affairs , Value and Real World Evidence to provide end-to-end statistical expertise ... approve tables, listings and graphs specifications. + Closely work with Medical Affairs to support statistical design, conduct secondary analyses of clinical and… more
- Grifols Shared Services North America, Inc (Lehigh Valley, PA)
- …for the therapeutic area(s). + Partners with the Medical Directors, National MSL Sr Director , and North America Medical Affairs Sr Director to develop ... and regions. The primary responsibility of the MSL Field Director is the management, performance, and coaching of a...of field medical plans, strategy, and activities within Medical Affairs , as aligned with goals and objectives. This position… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …to address strategic objectives to business partners. + Work closely with medical affairs , marketing, and IT teams to ensure alignment and integration of omnichannel ... Research, Analytics, Otsuka Information Technology (OIT), Sales Operations, and Medical/ Regulatory /Legal integrated business partners. **Minimum Qualification:** + Bachelor's degree… more
- System One (Bridgewater, NJ)
- …and enhancing product quality and regulatory compliance. Reporting to the Associate Director of Quality, this position partners cross-functionally with teams ... Title: Regulatory /QA Sr. Associate Type: Direct Hire...documentation. + Execute additional responsibilities as assigned by the Associate Director , Quality or Vice President, Quality.… more
- J&J Family of Companies (Titusville, NJ)
- …Job Duties and Responsibilities The overall purpose of the Commercial Quality, Senior Manager/QA Associate Director for the US LOC is to ensure high quality ... nurture strong, positive relationships with business partners in IT, Manufacturing, Regulatory Affairs , Commercial and Quality functional groups. + Demonstrated… more
