- 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
- Aequor (Newbury Park, CA)
- …requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities ... Utilize the Six Sigma method to support team processes. As the Global Labeling Lead product lead for marketed products, leads product-specific global labeling … 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
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… more
- Ascendis Pharma (Palo Alto, CA)
- 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
- AbbVie (Lake Bluff, IL)
- …Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , Regulatory Affairs, Strategic Global Labeling - Combination Products and ... other documentation for healthcare providers and end user. Under the Director of Strategic Labeling , they establish combination product and device labeling … more
- 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
- 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 positioning ... to Commercial teams during the development, review and approval of product labeling and advertising materials. + Work directly with Commercial teams from concept… more
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.… 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
- Abbott (Abbott Park, IL)
- …generic medicines. Our 114,000 colleagues serve people in more than 160 countries. ** Associate Director of Regulatory Affairs** **About Abbott** Abbott is a ... Lake County, IL currently has an opportunity for an ** Associate Director Manager of Regulatory Affairs** in...etc). + Principles and requirements of promotion, advertising and labeling . + Communication skills and ability to: + Communicate… 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
- 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
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director of Study Management? The job is located in the King of ... Prussia office. This is a hybrid position. You will report to the Director of CTS Study Management. **The Opportunity:** You will develop the clinical supply… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …application is true to the best of my knowledge. **Job Description** The Associate Director , US Medical Ad/Promo Regulatory serves as an internal expert ... development of marketing materials, including representation on global regulatory and labeling teams. + Provide leadership related to issues of importance; provide… more
- Abbott (Alameda, CA)
- …way patients and professionals measure, track and analyze glucose levels. As an Associate Director , project leadership, you will be responsible for Managing one ... budget and on strategy. These activities include coordination of artwork and labeling , in-house and third-party manufacturing, inventory phase in and phase out,… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs, you will be responsible for managing a team that develops and executes the strategy and ... supervision of individuals. + Provides guidance on development and review of labeling and promotional material for compliance with regulations; works closely with… more
- Astellas Pharma (Northbrook, IL)
- …further consideration. + Collaborates within Regulatory Affairs with RA liaison and labeling groups to ensure that contents of promotional and sales training ... in development. **Organizational Context:** Position will report to a Sr Director or Director of Promotion Review within US Regulatory Affairs. This individual… more
