- 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
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …More Years in the pharmaceutical industry preferred + 1 or More Years in regulatory affairs required + Experience in (s)NDA/BLA filing to FDA preferred ... with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development...will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …pharmaceutical industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- …The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... Director of Regulatory Affairs / Clinical Affairs in managing, coordinating, tracking and follow-up on FDA Communications and ANDA status for assigned… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …company that will inspire you and empower you to shine? Join us as an Associate Director , Global Regulatory Project Management and Strategic Planning - GI2 ... TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs)… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …true to the best of my knowledge. **Job Description** **About the role:** ** Associate Director , Nonclinical Regulatory Writing and Submission Support,** ... Here, you will be a vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory Writing and Systems (NRWS)… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …treatment of bipolar depression in adults as monotherapy and as adjunctive therapy. ** Associate Director / Director , Data Management** will oversee and provide ... Provide direction to study team to maximize compliance with regulatory requirements; review and suggest improvements to operating procedures...health related fields or closely related field + For Associate Director : Minimum of 7 years of… more
- Bristol Myers Squibb (Princeton, NJ)
- …partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory , IT, Audit, Finance and HR to build and integrate one global ... Include : + Conduct risk assessments specific to medical affairs and clinical trial /research activities, utilizing a combination...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Outsourcing & Vendor Management Pleasanton, CA, USA * Princeton, NJ, USA Req #385 Friday, August 16, 2024 Looking for a chance to make a ... dynamic and expanding mid-size company in the role of Associate Director , Outsourcing and Vendor Management. Your...clinical operations, data management, Pharmacovigilance Operations, Medical Writing and Regulatory Affairs is a plus. + CPM… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position: Associate Director , WW Medical Neuropsychiatry Strategy, Schizophrenia** ... **Location: Princeton Pike or Madison, NJ** The Associate Director of Medical Strategy, Schizophrenia will...WW Commercial, Research and Development, Global Drug Development, HEOR, Regulatory Affairs , and other global medical stakeholders.… more
- Novo Nordisk (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare...of the pharmaceutical industry including marketing, medical, access, public affairs , compliance, legal and regulatory as well… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... and assures that Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Patient Safety Clinical Operations in Cambridge, MA, ... Liaise with and advise study teams including Clinical Science, Data Management, Regulatory Affairs , and other functional areas locally/globally on matters… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Regional Marketing Conventions & Field Programs will be ... and more, while ensuring adherence to DS policies and procedures. The Associate Director , Regional Marketing Conventions & Field Programs is responsible… more
- Daiichi Sankyo Inc. (Basking Ridge, 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
- Novo Nordisk (Plainsboro, NJ)
- …of ensuring successful program execution. Relationships Reports to the Director , Commercial Communications. The position will interact with cross-functional ... including Commercial Strategy and Marketing, Market Access, CMR, Legal and Public Affairs . This position will also engage with various functions within NN/AS. Key… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Liaisons to ensure successful implementation of CDx and data collection + Supports Regulatory affairs in providing content and providing review of documents ... under the direction of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and by tracking and… more
- Sanofi Group (Bridgewater, NJ)
- …clinical care. We curate patient and scientific evidence and partner with commercial, regulatory , R&D, market access, and external affairs teams to develop ... and gastrointestinal diseases. **Main Responsibilities:** The Early Pipeline Gastroenterology Associate Medical Director reports to the Global Medical… more
- Novo Nordisk (Plainsboro, NJ)
- …Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical ... Senior Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential Functions + Innovation and change… more
- Edwards Lifesciences (Trenton, NJ)
- …their span of influence/control The Sr Manager, Biostatistics Level is lateral to Associate Director , Biostatistics (" Associate Director Biostatistics") ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more