- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver in… more
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Soleno (Redwood City, CA)
- …solutions to the PWS community. Summary of Job (brief description) The Associate Director/Director, Medical Affairs Strategy and Strategic Operations will manage ... medical & scientific strategic and operational input into core medical affairs activities. Internally, the Associate Director/Director will work… more
- Invivyd (New Haven, CT)
- …Work Instructions, and Safety Data Exchange Agreements. Work cross functionally with Regulatory Affairs and Quality Assurance functions to maintain current ... making a difference. Be part of Invivyd. Job Title: Senior Manager/ Associate Director, Drug Safety and Pharmacovigilance...knowledge of regulatory safety reporting guidelines and implementing relevant guidelines into… more
- BNP Paribas (New York, NY)
- …credit process jointly with the relevant Coverage team, and interface with Senior Credit Officers and Credit delegation holders to explain transactions. *Execution: ... notably in the transaction execution phase. *Comply with applicable laws, regulatory requirements, procedures, Group compliance standards, as well as with the… more
- Boehringer Ingelheim Pharmaceuticals, Inc (Ridgefield, CT)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director, Medical Customer Facing Excellence (MCFE) will ... & Responsibilities PEOPLE LEADERSHIP: Responsible for leading and collaborating with Medical Affairs and HP Ops personnel who may be aligned to multiple sub-pillars… more
- Stanford University (Stanford, CA)
- …of Obstetrics and Gynecology, with a secondary reporting relationship to the Associate Dean/Chief Financial Officer for the School of Medicine (SoM), which ensures ... and productivity management, hospital relationships, grant management, faculty and academic affairs , student affairs , external relations, and human resources.… more
- Urban Resource Institute (New York, NY)
- …all clinical notes are appropriately documented into the database In partnership with Associate Vice President of Justice Initiatives and Senior Director of ... DUTIES AND RESPONSIBILITIES CLINICAL LEADERSHIP Serves as a member of the Senior Program Leadership Team and works collaboratively across program leadership to… more
- Temple University (Philadelphia, PA)
- …development among departmental staff. Work with the Department Vice Chair of Academic Affairs , Department Chair, and Senior Associate Dean, Office of ... ensuring efficient allocation and compliance with institutional financial goals. Provide senior clinical leadership for the Hematology Section, fostering a culture… more
- Lifelancer (London, KY)
- … interactions. Cross-Functional Collaboration Partner closely with Clinical Operations, Regulatory Affairs , Program Management, CMC, and external CROs ... Type: Remote Job Contract Type: Full-time Job Seniority Level: Executive Senior Medical Director, Clinical Development (Oncology) Location: US Remote A global,… more
- University of Michigan (Ann Arbor, MI)
- …date, verifiable through the State of Michigan Department of Licensing and Regulatory Affairs Proficient communication, computer and basic mathematic skills are ... Fluency in reading, writing and speaking English. Pharmacy Technician Associate : High School Diploma or equivalent combination of education...through the State of Michigan Department of Licensing and Regulatory Affairs . One or more years of… more
- 3M (Austin, TX)
- **Job Description:** ** Senior Regulatory Affairs Associate ** **Collaborate with Innovative 3Mers Around the World** Choosing where to start and grow your ... environments to a 3M career.** **The Impact You'll Make in this Role** As a ** Senior Regulatory Affairs Associate ** , you will have the opportunity to… more
- Boehringer Ingelheim (Ridgefield, CT)
- …business impact. The Senior Associate Director, US Product CMC Regulatory Affairs is responsible for the direction, coordination and execution of all ... people. The Associate Director, US Product CMC Regulatory Affairs is responsible for the coordination...concerning assigned US investigational and marketed product interactions. The Senior Associate Director position is expected to… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs ...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
