- Merck & Co. (Boston, MA)
- …division manages key stages in drug development, collaborating with scientific, regulatory , and statistical teams to turn preclinical discoveries into clinical-ready ... to therapeutic area governance, functional area experts and development review committees.Contribute to assessment of internal and external opportunities identified… more
- Insmed Incorporated (San Diego, CA)
- …lifecycle management and remain in a validated state per associated SOPs, regulatory and security requirements. \tEnsure compliance and operational efficiency of ... Gdoc. Etc.) Provide real-time oversight and support during test execution Review executed protocols and provide test protocol deviation assessment and resolution… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …sub-teams to develop best practices for global initiatives in validation, quality compliance and material/ raw material support. The validation scope comprises a ... Myeloma space including validation, data analytics and commercial support. The Quality Compliance scope includes working on Quality related sub-teams such as change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... against project goals and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile… more
- Tris Pharma (Monmouth Junction, NJ)
- …to, pharmaceutical business functions and new product development processes (ie, Compliance , R&D, Product Development, Regulatory Affairs, Government Affairs, ... prior art searches for targeted technologies or productsPartners with R&D and Regulatory Affairs departments for preparation of Orange Book listings and patent… more
- Insmed Incorporated (NJ)
- …development and review of regional/global policies and procedures. Ensure compliance with all Company/ Regulatory requirements & TMF quality standards.Work ... conduct (including, but not limited to, ICH / GCP and regulatory requirements).Experience managing staff and providing oversight of department activitiesEffectively… more
- Eisai, Inc (Exton, PA)
- …implementing CAPAs.Help in the administration of external stability programs, ensuring regulatory compliance , adherence to protocol requirements and timely ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care… more
- Merck & Co. (Rahway, NJ)
- …milestones, and risks within our Company and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, ... development in addition to device development expertise.Strong familiarity with regulatory landscape associated with drug delivery combination product and design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Hemoglobinopathies Commercial Head. Collaborates closely with cross-functional teams, including marketing, medical , regulatory and legal, and other relevant NNI ... and compliant brand representation across all digital touchpoints Content Development & Compliance : Coordinate the review and approval process to ensure all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …contract lobbyists and customers, as necessary. Internal relationships include Legal, Compliance , Managed Markets Sales & Strategy, BioPharm, Medical , ... Novo Nordisk's positioning on state formularies if there are administrative, regulatory or legislative hurdles. Essential Functions Develops and manages proactive… more
