- Corcept Therapeutics (Redwood City, CA)
- …with scientific background or advanced scientific degree (MS, PhD or PharmD) Regulatory medical writing experience in the pharmaceutical industry/CRO environment ... the way we understand and treat disease. The Associate Director, Medical Writing ( Regulatory ) will provide strategic and operational medical writing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and… more
- Genmab (NJ)
- …will drive the development of high-quality clinical documents to support operational, medical , and regulatory activities across the Genmab portfolio. You will ... Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story...the story of our science through compelling clinical and regulatory documents. You'll be at the heart of a… more
- Merck & Co. (Rahway, NJ)
- …Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, ... of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …industry required Proven knowledge of the pharmaceutical industry, including medical , regulatory , clinical processes and market dynamics, especially ... in NNI KOL strategies, set high standards, and cultivate KOL and Medical Society relationships. This role will drive collaboration across functions to optimize… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ED&AA, IT, Ethics and Compliance, Commercial, Patient Services, CMR (Clinical, Medical , Regulatory ), Finance, and Novo Nordisk global colleagues. Externally, ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Novo Nordisk Inc. (WA)
- …and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical , Regulatory , Legal, etc) Assigned policy areas may include, but ... Tax, as well as other Market Access & Public Affairs teams, Medical , Legal, Compliance, Communications and other key stakeholders locally and globally. External… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and individuals in other NNI departments, including but not limited to Medical , Regulatory , Marketing, Sales, Commercial Operations, and Ethics, Compliance & ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including but not limited to - Commercial, Patient Services, CMR (Clinical, Medical , Regulatory ), Finance, and Novo Nordisk global colleagues, to deliver ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... 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)
- …project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, Regulatory , Medical , PR, agencies, actively soliciting team expertise ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of...Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... electronic records, validation processes, and regulated applications meet strict regulatory requirements, industry best practices, and internal quality standards.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs, finance, NNGlobal, and other relevant ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Alura Workforce Solutions (Princeton, NJ)
- Position Summary The primary responsibility for the WW/US Medical Communications Manager is the development and execution of a comprehensive, globally aligned ... strategic WW/US medical publications and content plans to support the effective...effective use of Client medicines. Develop and update WW/US medical content per clinical development program, publications, data presentations,… more
