- Catalent (Manassas, VA)
- Associate Director, Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical ... of every patient, consumer and Catalent employee. The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for… more
- DivIHN Integration Inc (Lake Forest, IL)
- …following opportunity, please contact one of our Talent Specialists Rashi at ### Title: Regulatory Affairs Associate Jr Location: Lake Forest, IL Duration: 7 ... Months Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory approval of medical devices. Monitor… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product… more
- Aequor (Newbury Park, CA)
- …requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... maintain positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and headquarter departments to accomplish… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Digital Innovation and Omnichannel Engagement will be responsible for the direction ... management of digital strategy, effectiveness and innovation initiatives supporting US Medical Affairs and Research & Development. The person in this role will drive… more
- Merck & Co. (Rahway, NJ)
- …a critical role in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within ... with cross functional teams across multiple geographies and functions.Exposure to Medical Affairs function within a reputed Pharma would be a plusStrong strategic… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- DivIHN Integration Inc (Columbus, OH)
- …product experiences, in-depth investigation of medical adverse events and works with Medical Affairs , Clinical, and Regulatory Affairs in the preparation of ... in a compliant and timely manner in order to meet applicable regulatory requirements. Coding cases using appropriate dictionaries, searching and inputting data in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with cross functional teams and various departments to include Marketing, Medical Affairs , Regulatory Affairs , Supply Chain Technical Operations, ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the Product Material Review Team (PMRT) with the Legal, and Medical Affairs departments, ensuring consistency of materials across brands and departments, adherence ... cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical trials is required Demonstrates technical expertise within Clinical Development, Medical Affairs , and Regulatory Affairs (CMR), staying up-to-date ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial insights and analytics, sales, medical/CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term plans,… more
- Merck & Co. (Rahway, NJ)
- …as needed.Works in partnership internally with GCTO country operations, finance, regulatory affairs , pharmacovigilance, legal and regional operations, HQ ... appropriately in a timely manner.Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological, and analytic… more
- Insmed Incorporated (Bridgewater, NJ)
- …of Record and media agencyWork closely with cross-functional partners including Legal, Regulatory , Compliance, and Medical Affairs , to align and compliantly ... Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director, HCP Marketing will be a key member of the Brand… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit. The ideal candidate will possess a ... and resource strategies within a VP Functional area of Clinical Development, Medical & Regulatory Affairs Works with business partners inside and outside of CMR… more
- Merck & Co. (North Wales, PA)
- …studiesWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... of clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be responsible… more
- Boehringer Ingelheim (St. Joseph, MO)
- …benefit programs reflect Boehringer Ingelheim's high regard for our employees. As the Manager/ Associate Director, Regulatory Affairs Pharma Safety & Efficacy ... you will: Act as Regulatory Affairs (RA) team member in projects...to handle high workloads and understanding of cultural differences. ** Associate Director - Additional Requirements** + Advanced degree (Doctor… more
- Catalent Pharma Solutions (Hillside, NJ)
- ** Associate Director, Regulatory Affairs ** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the ... every patient, consumer and Catalent employee. The primary duty of the ** Associate Director, Regulatory Affairs ** is to support regulatory strategy for… more
