- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions ... difference? The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational medicines.… more
- Genmab (Plainsboro, NJ)
- …oversight activities for safety related tasks, process invoices, and ensure regulatory compliance (including regulatory reporting requirements) for assigned ... assess the impact on drug safety processes at Genmab. Ensure compliance with regulatory guidelines and internal processes and procedures in order to be prepared for… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Genmab (Plainsboro, NJ)
- …be our best, and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert supporting the clinical development ... as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... Partnerships and Engagement, Customer Experience and Marketing Enablement, Employee Experience, Regulatory , PRB, PSP, FRM, Conventions, Global Marketing, Launch… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of ensuring successful program execution. Relationships Reports to the Director , Commercial Communications. The position will interact with cross-functional ... all programming is done compliantly, with close partnerships with legal, regulatory , compliance and medical Oversees project budget and accountable for staying… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.Reports to: Senior Director , Commercialization and Enabling Function Data ProductsJob Type: Full-TimePosition ... Medical Affairs and enabling functions.At Genmab, IT & Digital follows a global , product-based operating model; the PO, Commercial & Enterprise Data Products will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Global Safety Lead(s), Global Safety Lead(s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential Functions Innovation and ... the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and...external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical Programming team ... making and reporting to health authorities. You will report to the Director , Programming, and work closely with Data Management, Clinical Programming, Statistics,… 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… more
- Lilly (Philadelphia, PA)
- …around the world. **Position Overview:** The Associate Director - CMC Regulatory is responsible for leading global CMC regulatory activities for ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Merck (Upper Gwynedd, PA)
- …shortest time to approval by global regulatory agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in the General ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can… 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,** ... vital contributor to our inspiring, bold mission. As an Associate Director in the Nonclinical Regulatory...members (Clinical, Global Patient Safety, Program Management, Global Regulatory , Regulatory Operations, Drug… more
- Merck (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible for the review and approval of all US ... standards and policies and business objectives. Actively participate in labeling and global regulatory team meetings to ensure support for anticipated… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… 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, ... of clinical trial and Pharmacovigilance methodologies including detailed comprehension of global regulatory requirements. + Good cross-cultural understanding and… more
- Wolters Kluwer (Princeton, NJ)
- …to market for products and applications. We have an amazing opportunity for a ** Associate Director of Global Information Security Identity & Access ... within our Global Business Services division! The Associate Director of Global Information...5+ years of experience working with national and international regulatory compliance frameworks such as ISO 27001, SOX, BASEL… more
- Merck (North Wales, PA)
- …Description** We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... product labeling and obtain shortest time to approval by global regulatory agencies. You will independently manage...external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Bristol Myers Squibb (Princeton, NJ)
- …Lead , this role 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 compliance program into...their decisions. + Under the direction of the Senior Director , US and Above Market Medical and Market Access C&E… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …lead writer for important regulatory response documents and key components of regulatory submissions. + The Associate Director , Medical Writing is seen ... in order to bring life-changing therapies to patients worldwide. Join Takeda as a Associate Director Medical Writing where you will be responsible for medical… more
