- Merck & Co. (Boston, MA)
- …cost/size, number of trials, clinical trial design and Go/No Go decisions Serve as a subject matter expert and foster collaboration within QP2 and across ... the above duties and to develop the above capabilitiesLeverage significant pharmacometrics and subject matter expertise in a broad range of therapeutic areas,… more
- Merck & Co. (Rahway, NJ)
- …solve practical pharmaceutical development problemsRecognized as a subject matter expert in drug delivery and/or manufacturing technologyDemonstrated ... to safety and compliance standards. A successful candidate should have extensive drug product development experience, an affinity for hands-on problem solving,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …analyses and reporting of clinical trials. required- Having knowledge of all phases of drug development , including early and late phase clinical development ... development : Lead/contribute to the R programming system development . Act as R programming SME and...programming system development . Act as R programming SME and functional representative of R systems and infrastructure… more
- Merck & Co. (Rahway, NJ)
- …equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert , assist with acceptance testing (FAT, SAT), ... Job DescriptionAs a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops… more
- Merck & Co. (Durham, NC)
- …Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development Preferred Experience and ... and post launch process enhancements Provide post approval support and subject matter expertise support to ongoing manufacturing activities. Education… more
- Merck & Co. (Durham, NC)
- …needed to ensure the right support/awareness is given to issues as they ariseServe as a Subject Matter Expert ( SME ) during tours to provide area/process ... Durham, North Carolina. The new facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest,… more
- Merck & Co. (Durham, NC)
- …Ability to foster a collaborative work environment focused on mentorship, coaching, and Subject Matter Expert development Preferred Experience and ... technologies, continuous process improvements and post launch process enhancements Provide subject matter expertise support to ongoing manufacturing activities.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …EBR designs.Participate in design testing, release planning, and demos with partners.Serve as a Subject Matter Expert of MES for CAR-T and site initiatives ... Execution Systems Lead and will be responsible for EBR development and administration at the Raritan site to support...with alignment to Global Procedures.Act as a Site MES SME to support Quality Investigations, Corrections, and QMS records.Build… more
- Genmab (NJ)
- …Product Characteristics (SmPC), and their associated Patient Labeling Documents.Serve as the labeling subject matter expert responsible for advising teams on ... and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (eg, Core Data Sheet,… more
- Bristol-Myers Squibb Company (Princeton, NJ)
- …molecules and new modalities (ie peptides, ADCs). Serve as a drug metabolism subject matter expert in dynamic cross-functional team settings, to define ... is an expert in ADME, DDI and drug development of all modalities including small...and novel modalities. The successful candidate will be the subject matter expert and provide… more
- VIKTech LLC (Fort George G Meade, MD)
- VIKTech is seeking a Subject Matter Expert ( SME ) based out of Fort Meade, MD. The work environment is fast-paced and sometimes involves deadline ... requirements, from a project's inception to its conclusion for a particular IT subject matter area (ie, simple-to-complex systems) Assists other project members… more
- Eli Lilly and Company (Indianapolis, IN)
- …Job Summary : We are seeking a highly skilled and detail-oriented Visual Inspection Subject Matter Expert ( SME ) specializing in parenteral pharmaceutical ... for any inspection-related findings. Act as subject matter expert for the development ...vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (eg, healthcare and/or dependent day… more
- Genmab A/S (Princeton, NJ)
- …related activities to support regulatory filings and launch for assigned products. Act as a Subject Matter Expert ( SME ) for other safety physicians and ... Safety & Pharmacovigilance Physician serves as the safety expert accountable for the global safety strategy and overall...within the scope of this position *Excellent knowledge of drug development process *Requires a high level… more
- Insmed Incorporated (San Diego, CA)
- …play a key role within the Manufacturing Sciences Department, supporting clinical GMP drug substance and drug product production and quality control operations. ... the flexibility to support both large-scale production systems and research and development equipment when needed. The role will also manage the Computerized… more
- Revolution Medicines (Redwood City, CA)
- …Playing a critical role as the subject matter expert ( SME ) and project lead of Analytical Development within CMC function, the position will be ... technical expertise on analytical technologies and act as a subject matter expert for Analytical Development function. Select appropriate analytical… more
- Optum (Mukwonago, WI)
- …resource for staff which includes when other department leadership members are not present A subject matter expert who provides education / training to staff ... Access team A technical professional who assists with the development and tracking of department metrics and will provide...equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where… more
- Optum (El Paso, TX)
- …area of the clinic May mentor, onboard and train new team members. Serves as a subject matter expert as needed by the Lead Patient Services Representative, ... and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin… more
- Astellas Pharma, Inc. (Northbrook, IL)
- …reports, publications Ensure efficient planning, execution and reporting of analyses Advise as subject matter expert in specific data access partnerships ... Essential Job Responsibilities: Provide best-in-class data science support to Astellas drug development programs & marketed products in relation to RWD Design of… more
- Recursion (Salt Lake City, UT)
- …The Development Team is an empowered, execution-minded group of drug development professionals responsible for translating Recursion's innovative science to ... You'll Make Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology,...all the 3rd party data sources and serve as SME for Data Management. You'll also be proactive and… more
- Optum (San Antonio, TX)
- …and providers with respect to Medicare drug related issues May serve as a subject matter expert for the Pharmacy team and mentor new employees to ... diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities...for the Medical Assistance Program. May serve as a subject matter expert for the… more
