- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary 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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Eisai, Inc (Nutley, NJ)
- …a difference. 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 partners to deliver omnichannel and… more
- Merck & Co. (Rahway, NJ)
- …functional projects as appropriate.- Relevant projects may include Serialization, Labeling , Research Labs Hana S4 implementation, etc.Influencing individuals across ... a global matrixed organization (NA, EU, Asia- Pac and LA) to realize the above objectives.Communicating risks, issues, challenges and technical design and build status/progress.- Ensuring issues and risks are tracked and mitigation plans are in… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... and positive interactions with colleagues. Essential Functions Therapeutic Area: Assist Manager/ Director in review of labeling for marketed products and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Global Labeling Product Leader - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... + Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI)… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** 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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Sanofi Group (Cambridge, MA)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Bridgewater, NJ or Cambridge, MA **About the job** The ... Associate Director , US Advertising and Promotion serves...AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves...review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. + Develop solutions to complex… more
- J&J Family of Companies (Horsham, PA)
- Associate Director , Clinical Supply Integrator - 2406179836W **Description** Johnson & Johnson is recruiting for an ** Associate Director , Clinical Supply ... and profoundly impact health for humanity. Learn more at https://www.jnj.com/ . The Associate Director , is a matrix team leader responsible for the management… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Bristol Myers Squibb (Trenton, NJ)
- … of US Medical Oncology, Genitourinary (GU). The primary responsibility of this Associate Director is conducting strategic review of promotional materials and ... and objectives with the GU tumor portfolio. As a promotional review lead, this Associate Director role is a strategic partner who is solution oriented and… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Persons with a non-science degree having relevant professional experience may be considered. + Associate Director level: must have three to five (3-5) years of ... with Food Drug Cosmetic Act (FDCA) and for consistency with product labeling . Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… more
- University of Rochester (Rochester, NY)
- …Unity (CMSU), consisting of approximately 15 team members, with two Directors ( Director Operations and Director Quality Assurance) and the clinical trials ... licensing requirements, and professional standards pertaining to secondary packaging, labeling , blinding, distribution and return services of clinical supplies… more
- Merck (West Point, PA)
- …The successful candidate should have a working knowledge of clinical labeling , packaging and/or operations planning, including the understanding that all clinical ... label vendors. + Originate, design and verify label models in Clinical Supplies Labeling System + Initiate and implement process improvements with the aim of… more
- Bristol Myers Squibb (Summit, NJ)
- …careers.bms.com/working-with-us . **Position Summary** Bristol Myers Squibb is seeking an Associate Director , Principal Product Leader within the Cell Therapy ... teams + Act as QA approver for product specifications and product labeling + Provides supportive quality oversight and guidance during product launch +… more
