- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …as needed. - Works collaboratively with members of the global regulatory team (GRL, regional leads, CMC-RA, labeling, medical writing, regulatory operations, ... activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global requirements and provides an assessment of the… more
- Bristol Myers Squibb (Cambridge, MA)
- …with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading ... landscape, assessing regulatory risk, and developing global filing strategies. + Co- lead marketing application submission teams for indications that are at… more
- Takeda Pharmaceuticals (Lexington, MA)
- …CMC investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead . Assigned products include genetically ... and standards. + When in a GRA CMC Product Team lead role, prepares and maintains relevant...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead (s). + Prepare, coordinate ... filings and approvals of marketing applications as the CMC Regulatory lead + Regulatory experience in handling controlled substance applications will be… more
- Bausch + Lomb (Salem, MA)
- …Pharma core brands, policies, and associated business rules. + Serve as commercial lead for organizing all commercial KOL and Brand Activity for major ophthalmology ... with roles of escalating responsibility. + Ability to work in cross-functional team -based culture. + Independent execution of major projects. + Proven skills in… more
- Sanofi Group (Cambridge, MA)
- …adjusting input based on the stage of development. + **Cross-functional Collaboration** : Lead a cross-functional team of medical professionals in planning ... **Job Title:** US Medical Lead , Solid Tumors **Location:** Cambridge,...teams to ensure the successful planning and execution of medical affairs activities, clinical trials, and product… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …ultimate accountability for delivering and executing TA communication strategies for Takeda global medical affairs in close alignment with the global medical ... training, evidence generation and other cross-functional partnerships across the medical affairs ecosystem in support of a...ability to work across functions, regions and cultures and lead a large, diverse team . + TA… more
- Sanofi Group (Cambridge, MA)
- …with stakeholders across HEVA and with business partners including Value and Access, Medical Affairs , and regional and country Market Access functions + ... **Job Title:** HEVA Publications Lead Specialty Care **Location** : Cambridge, MA or...with key partners such as Value and Access and Medical Affairs + Establish a strategy for… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …, Immunology (Anti-CD38 Therapy Area) is a key strategic partner of the Immunology Medical Affairs team responsible for dynamically driving the strategic ... Immunology (Anti-CD38 Therapy Area) will: **Publications:** + Own and lead the Scientific Publications Team meeting and...including oversight of content for and design of the Medical Affairs booth, creation of FAQs, collection… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**OBJECTIVES:** + Leads flagships medical programs as defined by the Global Medical Affairs (GMA) Strategy Team and sub-teams + Leads GMA-driven ... matrix teams through complex decisions + Collaborates with other Medical Strategy Team (MST) members, Commercial and...strategy + Acts as a study Medical Lead for the GMA Medical Affairs… more