- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the ... party collaborators The position may manage a team of Global Labeling Leads (GLLs) and/or serve as...or a team of GLLs to ensure alignment of labeling content and strategy and to optimize… more
- Merck & Co. (North Wales, PA)
- Job DescriptionJob Description:The Associate Director , Marketing, HPV Scientific Strategy plays a critical role in supporting the HPV vaccine franchise.- The HPV ... with Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), Center for Observational and Real-world Evidence (CORE),… more
- Merck & Co. (Rahway, NJ)
- … global point of contact on those projects.Develops global regulatory strategy for their assigned products, to optimize labeling and obtain shortest time ... Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs...labeling and obtain shortest time to approval by global regulatory agencies.Reports to Associate Vice President, Executive … more
- Merck & Co. (North Wales, PA)
- …regulations, corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support ... Job DescriptionReports to the Director /Senior Director in the Office of...for anticipated promotional messages and claims (aligned with marketing strategy ) in clinical trial design and product labeling… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... product labeling and obtain shortest time to approval by global regulatory agencies.You will independently manage projects, functioning as the single,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable, ... Director , Clinical Development Join a Legacy of Innovation...diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... coding of AEs, medical history, and medications when needed- Clinical Development Expertise Strategy - In collaboration with the Global Clinical Lead (GCL), if… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... team and serves as ad hoc member to the Global Project Team for late stage projects. This position...working with contract manufacturing organizations CMO. This position develops strategy , prepares content templates and leads technical teams in… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director , Global Labeling Strategy Lead is a key ... to foster cross-functional collaboration and driving alignment of the labeling strategy and labeling content....approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight Committee - GLOC) providing… more
- Bristol Myers Squibb (Princeton, NJ)
- …of a team of Global Labeling Strategists responsible for driving labeling strategy and label development as well as managing cross-functional labeling ... global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities...the New Product Portfolio (NPP) responsible for driving early labeling strategy and label development + Proactively… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be responsible for ... Labeling cross-functional teams driving cross-functional collaboration and alignment of the labeling strategy and labeling content. Interface with Senior… more
- AbbVie (Florham Park, NJ)
- …and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for setting strategy and leading cross-functional, ... assigned therapeutic area(s). Responsibilities + Develops and directs regulatory labeling strategy planning for or across assigned...strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global … more
- AbbVie (Irvine, CA)
- …pipeline and considered for future opportunities. The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for ... TA knowledge and ensures strategic messaging and content of global regulatory dossiers. + May lead the Labeling Regulatory Strategy Team (LRST), and serve as… more
- AbbVie (Chicago, IL)
- …Operations, Biostatistics, Regulatory Affairs, Medical Affairs, and the Commercial organization. The Director represents HEOR at global regulatory and payer / ... negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies.… more
- Merck (Boston, MA)
- … point of contact on those projects. + Develops global regulatory strategy for their assigned products, to optimize labeling and obtain shortest time ... **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs...labeling and obtain shortest time to approval by global regulatory agencies. + Reports to Associate Vice President,… more
- AbbVie (Mettawa, IL)
- …consortiums, key opinion leaders, research organizations, patient advocacy groups). The Associate Director represents HEOR at global regulatory and payer / HTA ... negotiations in collaboration with cross-functional team members to drive internal strategy and alignment with global regulatory & reimbursement agencies.… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Regulatory Affairs Director - Global Regulatory Lead** **What you will do** Let's do ... this. Let's change the world. Amgen is seeking a Regulatory Affairs Director supporting products in Obesity Therapeutic Area. Global Regulatory Affairs (GRA)… more
- Merck (North Wales, PA)
- **Job Description** **Job Description:** The Associate Director , Marketing, HPV Scientific Strategy plays a critical role in supporting the HPV vaccine ... Global Medical and Scientific Affairs (GMSA), US, Senior Director of Medical Affairs (SDMA), Center for Observational and...with CORE to generate data to support the commercial strategy . + Representing the brand in LEAD labeling… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global Regulatory Strategy , is responsible for ... TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy Team (LRST). Serves as the… more
