- Merck & Co. (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director… more
- Merck & Co. (Boston, MA)
- …studies.Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical ... development projectsAssist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate… more
- GRAIL (Boston, MA)
- …products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval ... and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior...of Standard Operating Procedures and policy guidelines within the regulatory affairs department. + Perform other duties… more
- CSL Behring (Waltham, MA)
- **Position Title:** Senior Manager, Corporate & External Affairs , R&D Portfolio **Position Purpose:** The Senior Manager, Corporate and External Affairs , ... protect CSL's reputation and policy position. **Reporting Relationships:** **Reports to:** Associate Director, Corporate & External Affairs , R&D Portfolio **Main… more
- Parexel (Boston, MA)
- …FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate , you will serve as the ... and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs ...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Director, Regulatory Affairs (Oncology).** The Associate ... Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...Comfortable presenting to all levels of the organization including Senior Management. **Education and Experience** + Bachelor's degree in… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory intelligence needs and ... The Associate Director of Regulatory Intelligence leads...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs , ... The Associate Director, Scientific Communications manages the execution of...consistency, and compliance. This position reports directly to the Senior Director, CNS Medical Communications Lead. **Key Responsibilities Include:**… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study design and complex analysis issues, ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication. **Specifically, the Senior … more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the ... and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In alignment with TAU/MPD Labeling Lead,… more
- ConvaTec (Lexington, MA)
- …Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com **Position Overview:** The Associate Director plays a key role to the success of Convatec's ... clinical trials. The Associate Director, Clinical Trials Management oversees the management of...with all relevant regulations including ICH GCP guidelines, local regulatory requirements, and Convatec's policies and SOPs. **Key Responsibilities:**… more
- Rhythm Pharmaceuticals (Boston, MA)
- …to overcome barriers, together. Opportunity Overview We are seeking an experienced Associate Director, Scientific Communications as part of the North America Medical ... Affairs team to lead the strategic planning and execution...of the North America Medical team, reporting to the Senior Medical Director, North America, you will be accountable… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …a technical leader within a matrixed organization. + Collaborate with Supply Chain, Regulatory Affairs , IT, and other functions to ensure integrated quality ... **Job Summary** The Associate Director, Quality Operations will lead initiatives that...on key risk indicators and escalate critical risks to senior leadership. **Global Quality System Processes** + Oversee the… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …degree required; degree in Public Health, Life Sciences, Health/Research Administration, Regulatory Affairs , Bioethics, Health Law, or related field preferred. ... England state (ME, VT, NH, MA, CT, RI).** The Associate Director, Office for Human Research Studies (OHRS), oversees...reviews and limited IRB reviews as applicable. Act as senior OHRS representative at IRB meetings; assist reviews and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product ... all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate. + Collaborate with global… more
- Newell Brands (Boston, MA)
- …a related field. + 3-5 years of experience in tax incentives, government programs, regulatory affairs , or a related area (internships or co-op experience may be ... and collaborative environment where you can be your best, every day. The Associate Manager, Tax Incentives & Grants will support the Manager in identifying,… more
- State of Massachusetts (Boston, MA)
- …Deputy Commissioner for Boards, Operations, and Policy on Agency procurements. *External Affairs * * Coordinate with senior staff on legislation, policy ... of Occupational Licensure (DOL), an agency within the Office of Consumer Affairs and Business Regulation (OCABR), protects consumers by making sure the professionals… more
- Merck (Boston, MA)
- …+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... projects + Assist the Senior Director, Associate Vice-President/Vice-President and Product Development Team Lead in ensuring that appropriate corporate personnel… more
