- Merck & Co. (North Wales, PA)
- …for one or more of the QMS processes managed under GRACS(Global Regulatory Affairs & Clinical Safety) Quality &Compliance.Establishes and maintains an engaged ... regulations (eg, Good Regulatory Practice, Good Pharmacovigilance Practice, Good Clinical Practice,), safety guidelines and company policies and procedures.-May… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Reporting to the Sr. Director , Medical Affairs QA, the Director of Medical Affairs ... and working toward building a quality mindset with Medical Affairs .Support the Sr. Director 's Medical Affairs...expertise in the involvement of regulated activities for medical affairs , or clinical development. requiredMust possess a… more
- Eisai, Inc (Nutley, NJ)
- …the Medical Affairs department for assigned product(s). The Associate Medical Director utilizes expert medical, clinical and scientific knowledge in assigned ... we want to hear from you. The Associate Medical Director , US Oncology Medical Affairs - Women's...studies in relevant therapeutic area.Experience across areas of Medical Affairs ' functions or phase II/III/IV clinical trials… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Medical Director will provide medical leadership for medical affairs strategy, planning and supportive ... plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. SummaryThe Director US Medical Affairs (USMA) Oncology, under the direction of the ... Senior Director , USMA Oncology (US Medical Affairs team...compound.- Responsible for scientific communications and publications; interpretation of clinical data; ensuring consistency of clinical content… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director , Regulatory Affairs will serve as the regulatory leader on ... to cross-functional teams and senior leadership, as neededCollaborate with Clinical Development, Clinical Operations, CMC, QA/QC, Nonclinical, Program… 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 ... submissions, maintaining licences and liaising with government authorities.The Regulatory Affairs Manager plays a critical part in ensuring product approval,… more
- Merck & Co. (Upper Gwynedd, PA)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryUS Medical Affairs leader for assigned compound under the supervision and leadership of the ... Executive Director of Medical Research and Strategy, US Oncology Medical Affairs (USOMA). Develops the USOMA strategy and tactical plan as part of the US Brand… more
- Merck & Co. (Rahway, NJ)
- …and execution globally across Global Regulatory Affairs CMC (Global Regulatory Affairs & Clinical Safety), Research and Development (R&D), Manufacturing, and ... and dedicated colleagues while developing and expanding your career.The Executive Director , Chemistry, Manufacturing & Controls ( CMC) , Pre-approval Pharm will… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …health authorities. Leadership and Collaboration: Lead cross-functional teams in clinical development, medical affairs , and strategic planning.Foster ... OverviewThe Respiratory Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryMedical Affairs leader for the portfolio of early asset compounds under the ... supervision and leadership of the Global Medical Affairs (GMA) Franchise Head. Develops the GMA early strategy and tactical plan and leads the execution of the… more
- Merck & Co. (Charlotte, NC)
- …Work Arrangements:RemoteShift:Not IndicatedValid Driving License:YesHazardous Material(s):n/aRequired Skills:Accountability, Clinical Affairs , Clinical ... Clinical Trials, Data Analysis, Gastroenterology, Gastrointestinal Disease, Good Clinical Practice (GCP), Immunoassays, Immunotherapy, Leadership, Medical Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Associate Director Global Medical Affairs Oncology (GMA), under the direction of ... the Senior Director / Director , GMA Oncology (Global Medical ...drives execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.- Provides… more
- Merck & Co. (Cincinnati, OH)
- …reports to the Regional RMSD Team Leader - within US Medical Affairs , Global Clinical Development, Research and Development (R&D).--Primary Activities:Identify, ... Clinical Testing, HIV AIDS, Investigator-Initiated Studies (IIS), Medical Affairs , Pharmaceutical Medical Affairs , Professional Integrity, Professional… more
- Merck & Co. (North Wales, PA)
- …an active research pipeline.We are currently recruiting for a results-driven and strategic Director , Product Marketing Owner - HCP for HIV. As a key leader within ... HIV with the potential to add other assets which are in early development. The Director , Product Marketing Owner - HCP will play a critical role in charting the… more
- Eisai, Inc (Nutley, NJ)
- …Medical Education and Training colleagues and with the Global & US MALT (Medical Affairs Leadership Team) to develop and maintain all Medical Affairs training ... judgment; b) effectively communicate relevant and fair balanced scientific and clinical information about Eisai's products; seek feedback from MSLs, MSL Management… more
- Merck & Co. (Rahway, NJ)
- …and inclusive workforcePlanning and Project Management In alignment with the Executive Director of US Medical Affairs , provides project management to ensure ... Job DescriptionThe Regional Medical Scientific Senior Director - Team Lead (RMSD TL) is a credentialed therapeutic and disease expert (MD, PhD, PharmD, DNP, or DO)… more
- Merck & Co. (North Wales, PA)
- …in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; and assist the Executive Director in ... compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development, including… more
- Merck & Co. (Durham, NC)
- …effectiveness Regulatory Acumen and effective working relationship with Global Regulatory Affairs and Clinical Safety (GRACS) Demonstrated conflict resolution, ... Position Description: Under the direction of the Network Strategy & Execution Director , the Associate Director is responsible for assessing, leading and… more
