- Merck & Co. (South San Francisco, CA)
- …of early clinical strategy for novel therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical ... execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research,… more
- Merck & Co. (Rockville, MD)
- …our causes and maintaining a strong reputation as a science-led biopharmaceutical innovative leader .- We work in partnership with all of the our Research & ... company enterprise policy agenda.Responsibilities and activities of the Senior Director, Clinical Research Policyinclude:Leads and is responsible for the Company's … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Product Evolution Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies ... our future. The Position The Rare Bleeding Therapeutic Area Lead is instrumental in shaping and executing NNI's strategic...will also establish and build capabilities and oversee the leader of the thought leader liaisons that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …external stakeholders on important drug safety issues supporting Global Medical Safety Lead . Responsible for safety governance/oversight of Clinical Safety and ... leadership and management responsibilities and is considered a global leader for a therapeutic area or a large program... special projects cross-functionally as neededEnhancing the scientific and clinical experience for all CSPV staff through… more
- Aequor (Waltham, MA)
- …drug substance (DS), drug product (DP) and analytical development, DS/DP clinical manufacturing, and support of global regulatory filings from IND submission ... Waltham, MA. This role will build and maintain relationships with scientific staff , lab champions, functional heads, and support services to foster trust, facilitate… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial-related, GxP, Compliance, etc.) across the US and Canada… more
- Novo Nordisk Inc. (Pearland, TX)
- …reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such ... centers, HCPs and other stakeholders in a given geography. Utilizing approved clinical resources to support provider efforts to deliver appropriate care for… more
- Merck & Co. (Lower Gwynedd, PA)
- …in Lower Gwynedd Township, PA.We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The ... Location :West Point, Pennsylvania (with ~25% travel to Spring House, PA)Responsibilities : Lead a team of staff that span across Laboratory Operations… more
- Merck & Co. (North Wales, PA)
- …is the enterprise lead for establishing our company as an industry leader and sought-after partner in Health Literacy, Social Determinants of Health (SDoH) and ... industry trends and innovations related to health literacy, cultural competence, and health equity. Lead , coach and develop staff in alignment with business needs… more
- Merck & Co. (Rahway, NJ)
- …process development activities, compliance investigations/change management, authoring of GMP documentation, and lead other staff in the pilot plant as needed. ... enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... for the financial management and budget development of North America Clinical Operations (NACO). Responsible for driving financial oversight across trial portfolios… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …compliance with monitoring plan for on-site and remote site visits (expectations of staff contact, ISF review, IP review, SDV/SDR, etc.)Establish and lead the ... for ensuring oversight of Central Monitoring activities according to the Clinical Monitoring Plan inclusive of trend identification, impact assessments and creation… more
- Merck & Co. (Rahway, NJ)
- …enables gain of critical internal experience during scale-up of clinical supplies manufacturing, demonstration of new manufacturing technology/processes, training ... plant. The Process Engineer position reports to a Facility Leader and the successful candidate will be an integral...and new employees.As assigned, assist in the supervision of staff performing GMP activities and deliver training as needed.Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Novo Nordisk Inc. (Port Huron, MI)
- …reach the people who need them most. At Novo Nordisk, we are the world leader in diabetes care and a major player in defeating other serious chronic conditions such ... promoting Novo Nordisk's portfolio of products to HCPs and other office staff . Relationships Externally, the DCS I maintains relationships with physicians, physician… more
- Lundbeck (San Francisco, CA)
- …San Jose, San Francisco & Sacramento, CASUMMARY:Are you a results-driven biopharmaceutical sales leader looking to be part of an organization that values being a ... very exciting time to join our team as we lead the way in creating positive customer experiences! As...interactions with target customers, extended treatment team members, ancillary staff and providing them with individual coaching, feedback and… more
- Merck & Co. (Rahway, NJ)
- …execution of scientific & medical affairs plans for Ophthalmology). They build and lead a team of TA dedicated global and regional directors and associate directors. ... output) and real-world data generation of all Research & Development (R&D) V&I staff globally in collaboration with V&I Outcomes Research through the global Value… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …labeling in collaboration with the Global Regulatory Leads (GRLs) and Clinical Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads ... a team of Global Labeling Leads (GLLs) and/or serve as the Labeling Project Lead . This position leads labeling meetings for preparation of responses to comments from… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …aspects of technical transfer including analytical transfer, development studies, clinical supplies, manufacturing scale up, equipment and process qualification, ... to complete the technology transfer for customers. This position will lead , mentor and grow the Technical Service Department.Job ResponsibilitiesFunction as the… more
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