- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for ... CMC regulatory compliance activities for portfolio biologics to meet US , International Conference on Harmonization (ICH), and other applicable regulations. This… more
- Insmed Incorporated (Bridgewater, NJ)
- …and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed ... in preclinical study design and documentation as needed.Contribute to regulatory document writing (eg IB, IND, Integrated Summary of Immunogenicity).Engage… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... 2023, we became Great Place to Work-certified in the US for the third year in a row. We...our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director of Biostatistics is responsible for the statistical ... and our employees agree. In July 2023, we became Great Place to Work-certified in the US for the third year in a row. We are also honored to have been listed… more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs ( US RA AdPromo) as a...to the promotion of prescription drugs in the Uniteed States + The individual will require strong verbal and… more
- Bausch Health (Bridgewater, NJ)
- …mission of improving people's lives with our health care products. he Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, ... product advertising and promotional labeling pieces for compliance with regulatory agency requirements. **KEY ACTIVITIES/RESPONSIBILITIES:** + Provides regulatory… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US or EU. Preparation of updated Core Data Sheets, and EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, ... industry experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience required + Experience with ex- US … more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively ... of prescription drugs, biologics, and devices. **ESSENTIAL FUNCTIONS** + Provide regulatory leadership and guidance to Commercial teams during the development,… more
- Sanofi Group (Bridgewater, NJ)
- …time to prepare care plans for a later diagnosis. **Main responsibilities:** + Leads the US regulatory post-marketing activities. + As a key member of the Global ... Biology, Life Science, or related field) preferred **Experience/Professional requirements:** + US regulatory expertise in post-marketing activities required + At… more
- Sanofi Group (Bridgewater, NJ)
- **Main responsibilities:** + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... Life Science, or related field) preferred **Experience/Professional** **requirements:** + US regulatory expertise in pre-marketing/development activities required… more
- AbbVie (Branchburg, NJ)
- …with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director , Director , or ... Director ), in the development and execution of the regulatory strategy. Assigned matters may have a moderate impact...Key contributor responsible for the preparation and review of regulatory submissions consistent within US and Canada… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Project Scientist (Oncology) - 2406181923W **Description** At Johnson & Johnson, we believe health is everything. Our strength in ... https://www.jnj.com/ . Johnson & Johnson is recruiting for an Associate Director , Clinical Project Scientist, Oncology. The...Beerse, Belgium; Breda, Netherlands. Remote work options within the United States , United Kingdom and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the ... of study data of a clinical development program. The Associate Director leads in a matrix environment...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Clinical Pharmacology and Pharmacometrics - 2306103445W **Description** Janssen Research & Development, LLC is recruiting for an Associate ... patient population, and treatment paradigm. + Working knowledge of US , European, and Asian regulatory requirements and...Working knowledge of US , European, and Asian regulatory requirements and guidelines. + Good oral and written… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …role will support out Biostatistics Early Clinical Development Group. **As the Associate Director , Biostatistics, a typical day might include the following:** ... representing the company in professional associations, conferences, and publications. As an Associate Director , the incumbent will be responsible for mentoring… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Associate Director , Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures ... to manage one or more clinical scientists. As an Associate Director , a typical day may include...Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. **Summary** The Associate Director , RACMC Portfolio Products, will be responsible for ... CMC regulatory compliance activities for portfolio biologics to meet US , International Conference on Harmonization (ICH), and other applicable regulations. This… more
- Lilly (Branchburg, NJ)
- …Lilly and Active Pharmaceutical Ingredient (API) Contract Manufacturer representatives. The JPT Associate Director is the key business relationship owner and is ... materials are delivered on time and within downstream customer expectations. The JPT Associate Director will partner with Lilly's Process Research & Development… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are looking for an Associate Director , within our Clinical Pharmacology group. Providing strategic and scientific expertise, as well as representing Clinical ... Ridge, NJ location.** **A day in the life an Associate Director may look like:** + Develop...sections into clinical study reports. + Work closely with Regulatory to provide clinical pharmacology support of regulatory… more
