- Medtronic (Boston, MA)
- …guidance you need to own your future success. Together, we can transform healthcare. The Senior Director of Regulatory Affairs will lead the Regulatory ... be required. This role reports to the Vice President, Regulatory Affairs for the Surgical Operating Unit...staff and coach to ensure continuing development of regulatory skills + Keep Senior Management informed… more
- ConvaTec (Lexington, MA)
- …about Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be ... division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will...authorities + Provide guidance to business partners and junior regulatory staff regarding regulatory requirements… more
- Battelle Memorial Institute (MA)
- …Healthcare innovation is at the core of what we do. Join Battelle as the Regulatory Affairs Director where you will lead and drive the organization's ... regulatory affairs strategy for our Health Business...senior management. + Interface and coordinate with the regulatory agencies (ie, FDA) on submissions, approvals, external audits,… more
- Fresenius Medical Center (Waltham, MA)
- …can be fully remote. **PURPOSE AND SCOPE:** Ensures company products meet regulatory requirements by supporting all assigned regulatory aspects of product ... compliance. Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA liaison for… more
- Harvard University (Cambridge, MA)
- …data, and supporting students through the licensure process. This role reports to the Senior Associate Dean of Academic Affairs and Student Services and is part ... 65265BRAuto req ID:65265BRJob Code:S0558M FSS Academic Affairs Mgt IV Department Office Location:USA - MA...school. We do this by: + Hiring and retaining staff reflecting the diversity of those we serve +… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... **Job Description** **About the role:** Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- State of Massachusetts (Boston, MA)
- …to respond to press inquiries. * *Manage personnel.* o In coordination with senior managers, screen and interview for staff positions as vacancies arise. ... for this role. **Job:** **Administrative Services* **Organization:** **Office of Consumer Affairs and Business Regulation* **Title:** * Senior Director of… more
- Beth Israel Lahey Health (Plymouth, MA)
- …conflict resolution * Prior experience in direct responsibility for regulatory affairs and claims management strongly preferred **Registration/Certification:** ... for all random and/or unannounced surveys by The Joint Commission, DPH and other regulatory agencies. + Proactively educates leadership and staff regarding new … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …MDMP interacts and partners with marketed products R&D function leads ( regulatory affairs , pharmacovigilance, global development operations and project ... integrated partnership(s) with R&D functional leads on assigned R&D MPT ( regulatory affairs , pharmacovigilance, global development operations). + Collaborate… more
- Takeda Pharmaceuticals (Boston, MA)
- … management to plan, evaluate and recommend implementation strategy. As part of the Regulatory Affairs CMC team, you will report to the Executive Director and ... life-changing therapies to patients worldwide. Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will...Head, CMC Regulatory Affairs - Pharmaceuticals. **How you will… more
- Sanofi Group (Cambridge, MA)
- …a high level of confidentiality and professionalism at all times + Interface with staff and senior level executives, external partners and consultants and keep ... Team** : This role reports into the Global Medical Affairs Immunology team that is part of the Medical...function serves as a key strategic partner with commercial, regulatory , clinical, and market access on therapeutic solutions to… more
- J&J Family of Companies (Boston, MA)
- …stakeholders, in particular investigators, study trial coordinators and other site staff ; and internal stakeholders, including Medical Affairs and Marketing ... Senior Local Trial Manager - Oncology - 2406174196W...for local management of a clinical trial (or Medical Affairs data generation activity) in a country or countries.… more
- Harvard University (Cambridge, MA)
- …Manager Department Office Location:USA - MA - Cambridge Business Title: Senior Director of Compliance for Strategic Research InitiativesSub-Unit:Office of the ... and Skills: + Thorough understanding of a broad spectrum of the regulatory and policy requirements related to research administration and compliance. + Ability… more
- Pine Street Inn (Jamaica Plain, MA)
- Senior Housing Compliance Manager Department: Supportive Housing - Property Management Office: 82 Green Street Location: Jamaica Plain, MA Position Type: Management ... 82 Green Street, Jamaica Plain, MA JOB DESCRIPTION: SUMMARY OF POSITION: The Senior Housing Compliance Manager for Pine Street Inn, Inc. provides oversight of… more
- Blue Cross Blue Shield of Massachusetts (Boston, MA)
- …to ensure systems align with policies. + Collaborates with Government Regulatory Affairs , Network Management, Medical Economics, Benefit Administration, Provider ... and ICD10 CM and PCS code update review. Research and monitor State/Federal regulatory policy changes and publications such as CMS, AMA, specialty societies, AAPC,… more
- Bristol Myers Squibb (Boston, MA)
- …love of challenge._ Reporting into the Medical Value Liaison Field Director, the Senior Medical Value Liaison (MVL)/Executive MVL is a field-based role focused on ... policy makers, and other decision makers and influencers. **Responsibilities** ** Senior Medical Value Liaison** + Provide comprehensive, accurate, fair, balanced,… more
- State of Massachusetts (Boston, MA)
- …a physical office move/relocation. Collect data, prepare reports, and provide updates to Division senior staff and key staff in the Secretariat, the ... Division of Standards ("DOS"), an agency within the Office of Consumer Affairs and Business Regulation ("OCABR), is responsible for enforcing the accuracy… more
- Novo Nordisk (Lexington, MA)
- …as appropriate, in support of the development objectives for clinical programs, assisting Regulatory Affairs staff in compilation of submissions and ... Research, Bioanalytics, Clinical Operations, Medical Writing, Program Management, CMC and Regulatory Affairs . Interfaces with both internal GNAT and Novo… more
- Takeda Pharmaceuticals (Lexington, MA)
- …information / clinical expertise for assigned products to internal (Medical Affairs strategy teams, Therapeutic Area Units within R&D, commercial Brand teams) ... review process.** **2. Medical and scientific slides housed in the Medical Affairs slide repository.** **3. Other pertinent publications in the therapeutic areas as… more
- Bristol Myers Squibb (Cambridge, MA)
- …late-stage challenges (eg, trends in disease area therapeutic advances, and evolving regulatory , patient advocacy and market access environments) to create a vision ... in-depth know how and experience in matrix team leadership, relevant regulatory expectations, and overall drug development and commercialization. + Successful track… more