- Fresenius Medical Center (Waltham, MA)
- …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
- Sanofi Group (Cambridge, MA)
- About the Role The Associate Director, US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the ... prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a...be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered._** Sanofi Inc.… more
- Sanofi Group (Cambridge, MA)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory...be located in Cambridge, MA or Bridgewater, NJ. Hybrid remote working arrangement can also be considered._** Sanofi Inc.… more
- Humana (Boston, MA)
- …health first** The Director of State Public Policy role resides within the Corporate Affairs Department and will serve as an expert in state public payer, Medicaid ... businesses. The Director of State Public Policy role resides within the Corporate Affairs Department and will serve as an expert in state public payer, Medicaid… more
- Harvard University (Cambridge, MA)
- …and supporting students through the licensure process. This role reports to the Senior Associate Dean of Academic Affairs and Student Services and is part of ... 65265BRAuto req ID:65265BRJob Code:S0558M FSS Academic Affairs Mgt IV Department Office Location:USA - MA - Cambridge Business Title: Associate Director for… more
- Veterans Affairs, Veterans Health Administration (Boston, MA)
- …stress and PTSD. 4. Prepares and ensures compliance with all research regulatory requirements. 5. Prepares and submits initial, ongoing, and final reporting ... research focused committees including editorial boards, grant review panels, and regulatory boards. 1. Academic/Teaching/Training (5% effort) - Will hold a faculty… more
- Veterans Affairs, Veterans Health Administration (Bedford, MA)
- …Internship opportunities within the Department of Veterans Affairs , please visit: https://www.va.gov/EMPLOYEE/pathways-internship-program/. Incumbent will be given ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Participation in the Coronavirus...of 2 academic years of post-high school study or associate 's degree in the field of nursing. The required… more
- Merck (Boston, MA)
- …with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Regulatory Affairs , Global Medical and Scientific Affairs to ... **Job Description** **Position Description:** ** Associate Clinical Research Manager (aCRM) - Oncology** With...the TA-Head or CRD. + Requires understanding of local regulatory environment. + Scientific and clinical research knowledge is… more
- Merck (Boston, MA)
- …colleagues, GCTO Country Operations, other GCTO functional areas, Pharmacovigilance (PV), Global Regulatory Affairs and Clinical Safety (GRACS), IT, etc.) is ... to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new...by site or organization, with Friday designated as a remote -working day, unless business critical tasks require an on-site… more
- Takeda Pharmaceuticals (Lexington, MA)
- …potential issues. **Position Accountabilities:** * Collaborate with colleagues in Regulatory Affairs , Medical, Legal, Commercial, and Compliance organizations ... the US Medical team, you will report to the Associate Director, Ad/Promo Regulatory Review. You will... regulatory requirements. * Understand broad concepts within Regulatory Affairs and potential effects across the… more
- Takeda Pharmaceuticals (Boston, MA)
- …You will serve as the regulatory expert for labeling on the Global Regulatory Affairs subteam to ensure that regulatory labeling requirements are met ... life-changing therapies to patients worldwide. Join Takeda as an Associate Director, Global Labeling Lead where you will be...+ Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts… more