- J&J Family of Companies (Raritan, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for an Associate Director , Global Labeling Product Leader. This position is a ... and can be located in Raritan, NJ; Titusville, NJ; Horsham, PA. The Associate Director , Global Labeling Product Leader will be responsible for the following:… 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
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be ... reviews, revises, and approves content and context required of promotional labeling materials for prescription drug and medical device products. Must be… more
- Bausch Health (Bridgewater, NJ)
- …skills and values drive our collective progress and impact. The Associate Director , Regulatory Affairs handles regulatory development and ... key regulatory milestone, and activities for agency filing + Coordinate with the Labeling Lead for the development/maintenance of product labels + Ensure labeling… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Princeton, NJ, USA Req #444 Thursday, February 27, 2025 Looking for a chance to make a meaningful difference in the oncology ... 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 (Princeton, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . ** Associate Director , Global Regulatory Strategy, Neuroscience** **Position Summary:** ... plans with commercial and development plans + Develop target labeling and co-lead the cross-functional labeling team....Develop target labeling and co-lead the cross-functional labeling team. + Ensure consistent positions are presented in… more
- Endo International (Woodcliff Lake, NJ)
- …everyone we serve live their best life. **Job Description Summary** The Associate Director , Commercial Counsel provides timely legal counsel on commercial ... commercial and regulatory counsel and support on commercial initiatives and promotional labeling through the MARC review process. All incumbents are responsible for… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Global Patient Safety Medical Science reports to Head of GPS ... Assists in the preparation and revision of company product labeling as appropriate. + Assists in the preparation and...team (specifically from: Talent Acquisition Partner or Human Resources Director ) is not allowed. If this occurs your ownership… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director (AD) for US Medical Pulmonary will provide deep disease ... including promotional review, disease/brand and launch planning, access challenges, labeling changes, business reviews, etc. + Establish clear and challenging… more
- Integra LifeSciences (Princeton, NJ)
- …pathways to advance patient outcomes and set new standards of care. This Associate Director (ADGM) role has a global Downstream concentration and involves ... and/or line trimming, forecasting, pricing strategies, literature/video/sales support materials, labeling revisions, clinical studies, manufacturing and customer service/operations support… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …You will oversee preparation and maintenance of regulatory submissions, regulatory labeling and packaging for assigned products or projects; guiding and advising ... Module 1 documents for original IND, etc. + Oversees and guides labeling , packaging and associated information updates and maintenance in accordance with the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …strategic and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related ... RA Ad/Promo at Regulatory Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and… more
- Merck (Rahway, NJ)
- …ISS clinical trials (300+). GCS is accountable for the planning, sourcing, labeling , packaging and delivery of clinical supplies to clinical sites across more ... than 60+countries, all in accordance with US and WW regulations, company policies and Standard operating procedures. This individual will be responsible for managing external vendor(s)/partner(s) who provide resources and services that are critical to the… more
- Bristol Myers Squibb (Princeton, NJ)
- …with HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required; advanced scientific ... degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to broadly represent the… more
- J&J Family of Companies (Raritan, NJ)
- …**Team Leadership:** + Lead a team including Compound Market Access Leaders (CMALs) and/or Associate CMALs. + Develop, coach and train team members on own team as ... hypotheses to test primary versus secondary endpoints and implications for labeling . + Strong written and oral communication skills **Preferred Education &… more
- Kelly Services (Bridgewater, NJ)
- …and review for INDs, NDAs, and ANDAs, including annual reports and labeling . + Collaborate with Regulatory Management to ensure documentation meets regulatory ... eCTD format. + Communicate directly with and support Regulatory Product Leads and/or Director on assigned tasks. + Advise Regulatory Product Leads and/or Director… more
- Union County College (Cranford, NJ)
- …clean, and esthetically pleasant, physical environment. Under the direction of the Associate Director of Maintenance and Facilities, the Custodial Site assists ... custodial personnel. * Identifies staff opportunities and keeps the Associate Director informed. * Prepares requests for...records of equipment and supplies to ensure compliance with labeling and the requirements of the Right to Know… more