- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position,...working a Hybrid work consisting of three total days on- site per week, generally Tuesday, Wednesday and either Monday… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... involving investigational compounds in Immunology. With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of … more
- Merck & Co. (Rahway, NJ)
- …mission is to serve as PR&D's internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small ... provides a high degree of technical and project management responsibility. The Senior Specialist - Manufacturing Automation position will report to the Director,… more
- Merck & Co. (Rahway, NJ)
- …high-quality data from clinical trials conducted worldwide. In partnership with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality ... Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide...Regulatory Agency, as well as other established and emerging authorities. Lead and support GCP inspections, worldwide.- The CQOM may… more
- Merck & Co. (North Wales, PA)
- …the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: Demonstrates independence in preparing clinical regulatory ... Job DescriptionPosition Description: Senior Medical Writer The Senior Medical...(eg, protocols, clinical study reports, investigator's brochures, clinical sections of submissions) per company and regulatory requirements.… more
- Insmed Incorporated (Bridgewater, NJ)
- …teams, collaborating with subject matter experts in discovery, bioanalysis, pharmacokinetics, clinical development, CMC, and program management to drive the overall ... to contract research organizations. Provide strategic input to project teams and senior management regarding the potential impact of toxicology results on Program… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... veterans and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase...with a focus on patient safety and data integrity, site scientific engagement, and HA responsesInteractions with the internal… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...build connections, and work across boundaries. Proven ability to lead the planning and execution of cross-functional strategic change… more
- Merck & Co. (Rahway, NJ)
- …your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... Job DescriptionDevice Development Principal Scientist - Device Development Lead (Director Equivalent) Our company's Device Development (DD) Team designs, develops,… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Merck & Co. (Rahway, NJ)
- …and digital solutions are implemented, and sponsor technology adoption across site operations to ensure value delivery on agreed business outcomes. Provide ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations Technology… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...pursuing novel solutions that allow the research teams on site to work with data driven sciences. Major tasks… more
- Merck & Co. (Boston, MA)
- …and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder minimal guidance of the Senior Director or Director, Business Development Execution, the primary function includes coordinating various GRACS ... deal.Performs all responsibilities of the GRACS Business Development Execution Lead (or Integration Lead for Acquisitions/Mergers/Collaborations or Transition… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.- The AVP provides strategic oversight for the early ... clinical space, determining and implementing the initial ...Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets… more
- Merck & Co. (North Wales, PA)
- …stakeholders within HHDDA, marketing, sales, business operations, medical and finance. Lead other Directors, Associate Directors, Senior Specialists with direct ... role will be an independent contributor as well as lead a team and, together, will act as the...thought leader and strategic partner for commercial teams and senior marketing leaders. Engage, influence and, if needed, challenge… more
- Merck & Co. (North Wales, PA)
- …Responsibility Essential function(s) includes, but is not limited to: Reporting to Senior Management of the Medical Device and Combination Product (MDCP) Quality ... Control and Device Risk Management documentation for regulatory filings, clinical supply, development, design transfer qualification and post marketing… more
