- Merck & Co. (Boston, MA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- State Street Corporation (Boston, MA)
- Who we are looking for Asset Liability Management (ALM), a division of Global Treasury, is responsible for managing the corporate balance sheet, net interest income ... recommending strategies for sustaining and growing NII while being mindful of regulatory constraints. ALM routinely collaborates with other areas across Global … more
- Olema Oncology (Boston, MA)
- …Drug Safety and Regulatory Affairs functions to drive compliance with global regulatory requirements and company policies to safeguard the integrity of ... advanced degree is a plus Demonstrated knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements Advanced knowledge of Quality… more
- Compass Group (Boston, MA)
- …differentiates us as a company as we continue to raise the bar. Job Summary: The Global Account Director (GAD) is the key senior partner to our clients for ... Ireland and India. Furthermore, this role works closely on global reporting and data management for the portfolio, working...elevate the F&B experience for all employees and guests. Lead all client and Compass reporting activities, including QBRs,… more
- Merus (Cambridge, MA)
- …Time Location: Cambridge, MA Description The Senior Director , Medical Writing will lead all clinical and regulatory medical writing activities in support of ... Senior Director , Medical Writing Department: Clinical Operations Employment Type:...regulatory requirements. Your role Strategic Leadership Build and lead the global medical writing function to… more
- Socotec (Charlestown, MA)
- …it has been officially certified as a Great Place to Work by the renowned global authority on workplace culture, Great Place to Work(R). Job Description Lead ... Conduct contractor due diligence and bid evaluations Engage with public and regulatory agencies Qualifications 8-10 years of experience in Owner's Project Management… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US...Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies… more
- Takeda Pharmaceuticals (Boston, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the Job** ... be critical in helping our teams accelerate progress. The Director , Global Regulatory Affairs -...Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission types...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director , Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About ... critical in helping our teams accelerate progress. The Associate Director , Global Regulatory Affairs -...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
- Takeda Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... CMC related matters. + Proven ability to liaise with Regulatory Agencies, having served as lead in...international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… more
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Sr. Director , Global Market Access and Pricing Lead - Oncology **Location:** Cambridge, MA **About the Job** Sanofi Genzyme's Oncology ... and prepare for pipeline future launches. The primary purpose of the role is to lead development, update and execution of the Global Market Access and Pricing… more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability for collaboration ... best of my knowledge. **Job Description** **Role Objectives:** + The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
