- 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
- 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
- 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
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …Range $120000.00 - $130000.00 Salary Description Job Title : Manager, Clinical Affairs (Case Review Board) Manager Title: Senior Director, Clinical Affairs ... Job Description Summary: Reporting to the Director of Clinical Affairs , the Manager, Clinical Affairs (CRB) will... (CRB) will be responsible for case planning for global clinical trials and collaborating with internal and external… more
- Nura Bio (South San Francisco, CA)
- …other global health authorities, to facilitate the approval process. * Lead regulatory planning and submission activities, including authoring or overseeing the ... of the central, peripheral, and ocular nervous system. The VP/Head of Regulatory Affairs will be a key member of our clinical leadership team, responsible for… 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
- 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. (North Wales, PA)
- …across the enterprise including Sales, Global Marketing, Data & Analytics, Medical Affairs , Policy, Payer Marketing, Finance, Manufacturing, L&D, Global ... HIV Treatments and will be based in the Upper Gwynedd, PA office.You will lead and mentor a high-performing CAT, comprised of several direct reports who are brand… more
- Eisai, Inc (Nutley, NJ)
- …communication materials, internal training content, etc.). Collaborate with other stakeholders across Global & US Medical Affairs functions and other ... relevant medical education deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic...focus of these plans and activities will be either global , US-focused with intended use and adaptation by other… more
- JENAVALVE TECHNOLOGY INC (Irvine, CA)
- …$120000.00 - $140000.00 Salary Description Job Title : Senior Product Manager, Global Marketing Supervisor/Manager Title: Sr. Director, Global Marketing Job ... Summary: We are seeking an experienced product manager to support global marketing activities, including strategic market expansion, therapy development, patient… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support tasks of ... documents (eg SOPs) as appropriate.Collaborate with cross-functional teams (eg, Medical Safety, Regulatory Affairs , Epidemiology) to ensure benefit-risk… more
- Merck & Co. (Boston, MA)
- …discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations)Provide clinical ... environment of mutual respect, encouragement, and teamwork. As part of the global team, you will collaborate with talented and dedicated colleagues in Translational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will serve as the primary regulatory advisor for cross-functional teams, including marketing, medical affairs , and legal, on the product material review team ... as the primary regulatory advisor to cross-functional teams, including marketing, medical affairs and legal, to align promotional strategies with… more
