- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/ Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Aequor (Thousand Oaks, CA)
- …submission/documents experience Or Bachelor's degree and 5 years of Writing Regulatory or scientific submission/documents experience Or Associate 's degree and ... FULLY REMOTE final BR - / hour Regulatory Writing Manager In this vital role you...role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory… more
- Merck & Co. (North Wales, PA)
- …the Director/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director, Omnichannel Marketing and Media position reports to the Senior Director, Omnichannel ... Marketing (HCP and Patient). The associate director will also partner closely with key internal...and strategies across target audiences as well as ensure regulatory /legal and compliance requirements are met.This role requires strong… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... collaborate to discover the next medical breakthrough.Position Description: The Associate Principal Scientist Statistical Programming leads the statistical programming… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Catalent (San Diego, CA)
- Quality Assurance Associate II - Manufacturing Catalent Pharma Solutions in San Diego is currently hiring a Manufacturing Quality Assurance (MQA) Associate II ... maintaining, and assuring compliance with quality systems requirements and applicable regulatory requirements; to advance the development and manufacture of drug… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- 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 ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager's (CRMs) and/or ... HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs, Global Medical and Scientific Affairs to align on key… more
- Merck & Co. (Rahway, NJ)
- …DescriptionAssociate Principal Scientist, Small Molecule Research & DevelopmentIn your role as Associate Principal Scientist, you will be part of a team developing ... imaging tools, and data analysis. You would also contribute towards regulatory submissions to enable clinical trials. Your main responsibilities, which are… more
- Eisai, Inc (NJ)
- …this is your profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... outsourcing.In-depth understanding of GCP/GLP guidelines, audit processes and agency regulatory requirements.Excellent verbal, written and interpersonal skills and ability… more
- Eisai, Inc (Nutley, NJ)
- …be primarily responsible for providing counsel specific to Eisai's pharmaceutical regulatory needs, including sales and marketing, scientific exchange and other ... Anti-Kickback Statute, False Claims Act, PhRMA Code and FDA regulatory guidelines. Serves as the legal representative on promotional...standing of a state bar. Strong knowledge of FDA regulatory and fraud and abuse law. Ability to learn… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Merck & Co. (Millsboro, DE)
- …Delaware seeks to add an Attending Veterinarian in the role of Associate Director.This position will have overall responsibility for oversight and administration of ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …cross functional assistance for PGC, Learning Management System (LMS) and Regulatory , as needed. ResponsibilitiesEditorial Review of Materials Review and consult ... projectsProvide cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved promotional material… 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
- Novo Nordisk Inc. (Atlanta, GA)
- 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
- 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 ... within budget and adhering to digital governance, legal, compliance and regulatory standards. Requirements Bachelors in science or related field; advanced degree… more
- Merck & Co. (North Wales, PA)
- …Hybrid work model (combination of in-office and work from home abilities).The- Associate Director, Digital & Omnichannel Innovation for US Oncology-focuses on digital ... build partnerships and trust with Commercial Legal, Compliance, Privacy and Regulatory colleagues to effectively alleviate concerns and mitigate real/perceived risk… more
