- Fidelity TalentSource LLC (Boston, MA)
- …Development Data Science Team is seeking a highly motivated and technically proficient Director of Data Science who is passionate about applying new AI technologies ... in the finance domain. This individual will act as the technical lead , collaborating with investment professionals (such as quants and portfolio managers) as well as… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:As a Director of Compensation at Fidelity, you will lead compensation initiatives and programs, and work in partnership with the HR team to ... diverse suite of Fidelity s business and support groups.The Director of Compensation is a subject matter expert on...Services & Legal, Risk & Compliance, Enterprise Technology & Global Services, and Fidelity Institutional & Fund and Brokerage… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide function that supports the Finance strategic objective of ensuring ... role will report to a Senior Manager or a Director within the GFC function. The Expertise and Skills...effectiveness of key ITACs, manual controls and key reports (IPEs) Lead or participate in process walkthroughs with process and… more
- AbbVie (Boston, MA)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director , Global Regulatory Lead , is responsible for ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… more
- Novo Nordisk (Lexington, MA)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... on development strategies, and deliver on associated regulatory activities + Lead the Global Regulatory Matrixed Team in defining and executing the … more
- AbbVie (Boston, MA)
- …driver indications for a product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development & execution of the ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada (Oncology) is… more
- Takeda Pharmaceuticals (Boston, MA)
- … Project Management and Strategic Planning - Neuroscience where you will partner with the Global Regulatory Lead (GRL) on Global Regulatory ... Affairs Team. **How you will contribute:** + As Associate Director , Global Regulatory Project Management...and Strategic Planning, you will partner with the program Global Regulatory Lead (GRL), co-… more
- Sanofi Group (Cambridge, MA)
- …The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare Disease, ... of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as...truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those… more
- Sanofi Group (Cambridge, MA)
- **Our Team:** The Global Regulatory Affairs Device team is a globally diverse team supporting the medical device, combination product, digital health and ... portfolio of products. The team is part of the Global Regulatory Affairs, Regulatory CMC...is comprised of more than 1800 people. The Device Regulatory Lead for Specialty Care & Vaccine… more
- Sanofi Group (Cambridge, MA)
- 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
- Pfizer (Cambridge, MA)
- …benefit from our current and future medicines. The Global Senior Medical Director - Abrocitinib Team Lead will report to the VP, Medical Dermatology ... Global Franchise Lead . The Senior Medical Director will develop...atopic dermatitis disease care gaps, HCP and patient perspectives, regulatory and market access dynamics and integrate these insights… more
- Pfizer (Cambridge, MA)
- …on doing better for Pfizer's patients and healthcare. **ROLE RESPONSIBILITIES** + Proactively lead the development of the Global HTA evidence generation strategy ... + Lead and supervise the design and execution of global HEOR studies (eg, network meta-analyses, non-interventional studies) from concept through publication,… more
- Merck (Boston, MA)
- …final approval of all submissions and associated documentation. + Provides expertise as the Global Regulatory Lead to Product Development Teams and ... regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or... Director or Associate Vice President, Therapeutic Area Lead . + Develops worldwide product regulatory strategy… more
- Takeda Pharmaceuticals (Boston, MA)
- …Global regulations to ensure CMC compliance within the organization + Lead regulatory compliance assessment with respect to filing requirements for ... life-changing therapies to patients worldwide. Join Takeda as a Director , Regulatory Affairs Vaccines CMC where you...where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in… more
- Editas Medicine (Cambridge, MA)
- …development and ensure compliance with applicable EMA/FDA/ICH/WHO/ Global regulations and regulatory guidance and guidelines. + Lead CMC related interactions ... trials applications, marketing applications, agency briefing packages and response to regulatory authority queries. The Director will incorporate regulatory… more
- Sanofi Group (Cambridge, MA)
- …member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist leverages their ... on the TPP, business planning, governance, and committees. May be requested to lead Global Regulatory Team meetings + May represent GRT strategic position on… more
- Sanofi Group (Cambridge, MA)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively with ... impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director ...and communications with trade associations and health authorities on regulatory policy matters. + Lead proactive advocacy… more
- Pfizer (Cambridge, MA)
- **ROLE SUMMARY** + Reporting to the VP, Global Gastroenterology Medical Lead , the Senior Director , Gastroenterology (GI) and Biosimilars is an integral ... the GI GMAT and will work closely with the Global Medical Gastroenterology lead to develop the...the strategic GI medical plan across assets + The Global Senior Director , GI and Biosimilars… more
- Takeda Pharmaceuticals (Boston, MA)
- …plans, and appropriately escalate issues to Global Labeling management and the Global Regulatory Lead + Recommend strategies and labeling language for ... therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where...the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that… more
- Pfizer (Cambridge, MA)
- …matter expertise and drive critical strategic discussions at Senior Leadership forums. + Lead Global cross functional and local preparation of Vepdegestrant EU ... Global Access Strategy and Pricing (GASP) Senior Director role directly impacts the ability to achieve business...the other GAV colleagues (USMA, HV&E). This role will lead the advancement of the integrated value and access… more
