- 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
- 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
- Insmed Incorporated (NJ)
- …each other, and for the future of science, we're in. Are you?About the Role:The Medical Director, Medical Affairs - Dermatology role will be responsible for ... cycle for hidradenitis suppurativa (HS) via leadership, mentorship, and execution of the Medical Affairs strategic vision. This position will report directly to… more
- Insmed Incorporated (NJ)
- …organization.Previous leadership experience in medical affairs and ability to lead by influence within a matrixed team. Global experience or experience in ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...the Role:The Medical Director, Medical Affairs - Pulmonology will develop, implement, and lead… 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
- 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)
- … (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
- 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
- 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
- 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
- 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
- Merck & Co. (WY)
- …foundational elements of diversityConsistent adherence to field and corporate policies and Global Medical Scientific Affairs (GMSA) strategy, including field ... Clinical Affairs , Clinical Studies, Clinical Trials, Data Analysis, Leadership, Medical Affairs , Medical Relations, Pharmaceutical Medical … 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
- Daiichi Sankyo, Inc. (New York, NY)
- …role. The territory includes NY, VT, NH, ME, MA, CT, RI. As member of US Medical , Field Medical Affairs team, the Principal Medical Value Liaison/Sr. ... , Managed Markets and Brand strategies, and by providing input/participating in Medical Affairs and FMA strategic planning processes. Develops the ability… 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
- Insmed Incorporated (NJ)
- …development to engage pulmonologists, ILD specialists, and community physicians.Partner with Medical Affairs to ensure scientific and clinical insights inform ... relevant while globally aligned.Cross-Functional LeadershipPartner with Sales, Market Access, Medical Affairs , and Commercial Effectiveness to ensure alignment… more
- Insmed Incorporated (NJ)
- …development and go-to-market frameworks tailored to dermatologists treating HS.Partner with Medical Affairs and Commercial Effectiveness to ensure key clinical ... Global Brand Strategy Team, etc)Work closely with Legal, Regulatory, Compliance, Medical Affairs , Market Access, Advocacy, and Commercial Operations team… more
