- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related to evidence generation, scientific engagement and communication- Serves as Global Medical Affairs Team (GMAT) Lead , to gain strategic and ... for the portfolio of early asset compounds under the supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA early… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(GMA), under the direction of the Senior Director/Director, GMA Oncology ( Global Medical Affairs team lead for compound), is responsible for assisting ... compound or indication.Responsibilities- Support GMA the development of the Global Medical Affairs strategy and...may serve as deputy compound lead in Global IIS Review Committee meetings.- Leads selecting medical… more
- Merck & Co. (North Wales, PA)
- Job Description Role Summary: The Global Senior Director Medical Affairs (GDMA) is a subject matter expert in their area of responsibility (eg, defined ... asset, vaccine) and responsible for driving execution of the Global Medical and Scientific Affairs ...(ROW). -The GDMA may also be appointed as aV&I Lead for their disease/asset area, which includes additional organizationally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director, Global Oncology Medical Affairs , Medical Analytics will ... analytics infrastructure and developing and executing analytical capabilities for the Medical Affairs function. This role will leverage advanced analytics,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Project Management: Lead the end-to-end quality execution across Medical Affairs programs, ensuring compliance with GCP, GPV, GPEP, ... quality improvement.Deputize for the Sr. Director, Medical Affairs QA as needed. Cross-functional and Global ...and/or quality plan, fostering a culture of quality within Medical Affairs . Lead strategic initiatives in… more
- Insmed Incorporated (NJ)
- …develop, implement, and lead the therapy portfolio strategy and planning for Medical Affairs across all geographic regions ensuring a cohesive approach. This ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...role will develop and lead all medical affairs activities… more
- Lundbeck (North Hyde, SD)
- Lundbeck Australia is currently seeking a highly motivated and experienced Regulatory Affairs Manager to lead and manage regulatory activities across our product ... and CROs. Lead internal audits and represent the affiliate in global QA forums. Maintain SOPs, Crisis Management documentation, and Risk Management Plans.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … (USMA) Oncology, under the direction of the Senior Director, USMA Oncology (US Medical Affairs team lead for compound), is responsible for assisting ... FMA (Field Medical Affairs ), MIE ( Medical Information and Education) and global functions...Sponsored Research (ESRs) and may serve as deputy regional medical lead in Global IIS… more
- Insmed Incorporated (San Diego, CA)
- … and relevant teamsWith oversight from the VP of Regulatory Affairs , lead the development and implementation of global regulatory strategy plans to ... as the regulatory point of contact for interactions with FDA and other Global health authoritiesAssist/ Lead communications with FDA and with other Health… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... future of science, we're in. Are you?About the Role:The Associate Director, Regulatory Affairs , CMC will be responsible for reviewing the CMC post approval changes,… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... regulatory documents for agency meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings.… more
- Merck & Co. (Rahway, NJ)
- …teams including Product Development (PDT), Global Commercial (GCT), Outcomes Research, Medical Affairs , as well as regional and country teams to ensure ... our ophthalmology products. In this role, the Director will lead the development and execution of global ...tools in collaboration with Commercial, Clinical Development, Outcomes Research, Medical Affairs , Policy and regional and country… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... to drive operational excellence, develop teams, and deliver measurable results.What you own: Lead and grow the Integrated Process Team (IPT) - coach managers and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Proactively shifts CDx strategy to account for external shifts. Partners with Medical Affairs and Commercial to support scientific collaborations with KEEs, ... the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to develop CDx… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Readiness activities and life cycle management from a medical perspective- Participates in Global Medical Affairs committees as requested. Serves as US ... Medical Affairs Lead , to gain strategic and planning...US IIS Review Committee, for assigned compound. Collaborates with Global Medical Affairs and across… more
- Merck & Co. (Rahway, NJ)
- …limited CMC post-approval-changes.Leverage industry and agency connections in partnership with Regulatory Affairs Global Regulatory Policy and the Head of CMC ... cross-modality projects as an extension of the overall Regulatory Affairs CMC Leadership Team.-This Lead plays a...critical role in driving alignment and execution globally across Global Regulatory Affairs CMC ( Global … more
- Merck & Co. (Charlotte, NC)
- …with virtual meeting platformsConsistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field ... Gastrointestinal Disease, Good Clinical Practice (GCP), Immunoassays, Immunotherapy, Leadership, Medical Affairs , Medical Relations, Microsoft Word,… more
- Merck & Co. (Rahway, NJ)
- …& Implementation (V&I) Outcomes Research position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes ... The incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates… more
- Insmed Incorporated (NJ)
- …programs as requested by Insmed R&D, Clinical Development & Operations, and Medical Affairs Departments.Partners with Clinical teams and Therapeutic Area leads ... all Insmed departments and functions. Further proactive communication with Commercial, other Medical Affairs functions, Clinical and business partners as it… more
- Insmed Incorporated (NJ)
- …seamlessly in a matrixed organization.Previous leadership experience in medical affairs and the ability to lead by influence.Demonstrated experience managing ... Senior Director, Scientific Communications has a strategic leadership role within Global Medical Strategy & Communications with responsibility for leading… more
