- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Merck & Co. (North Wales, PA)
- …Vice President in BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and ... skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in directing multiple… more
- Acadia Pharmaceuticals Inc. (San Diego, CA)
- …States and Canada for the treatment of Rett syndrome. Our clinical -stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, ... three days per week. Position Summary This position will support Government Affairs and Patient Advocacy leadership teams to develop reports that communicate metrics… more
- Glycomine (Boston, MA)
- …in the quality of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager / Clinical Project Manager ... of clinical trials (Phase I-III). The Senior Clinical Project Manager / Clinical ...Plan, etc). Collaborate cross functionally with internal teams, including Clinical Development, Regulatory Affairs , Translational Medicine and… more
- Fred Hutchinson Cancer Center (Seattle, WA)
- …departments and external organizations and agencies. The position reports to the Senior Project Manager in the IDS Program. Responsibilities Prepare, track and ... regarding patient consent. Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs , etc.). Stay abreast of new… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- … Operations, Regulatory, CMC, Marketing). Minimum of 5 years' experience as a clinical project /program manager leading complex pharmaceutical, academic or ... & Evidence Generation, US Medical Lexington, MA Hybrid OBJECTIVES/PURPOSE: Provides clinical project management and leadership to ensure successful operational… more
- Omni Inclusive (Princeton, NJ)
- …field medical content, congress symposia, PReP support Title: Cardiovascular Medical Strategy Project Manager Organization: US Medical Affairs Reporting to ... literature *Understanding of the US Healthcare system, the pharmaceutical industry and clinical and health economic practices in the US is required *Excellent… more
- Katalyst HealthCares and Life Sciences (Philadelphia, PA)
- …strategies. Work closely with internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance, and Regulatory Affairs , to ... planning and issue resolution. Ensure timely and quality deliverables within project timelines and budget constraints. Develop and implement validation checks,… more
- Capstan (Santa Cruz, CA)
- …part 812, 50, 54, and other relevant regulations. As a vital part of the Clinical Affairs team, you will collaborate with key stakeholders to execute clinical ... part of a team revolutionizing heart valve treatment! Description We are seeking a Clinical Trial Manager to lead premarket clinical studies for Capstan… more
- Hologic (San Diego, CA)
- …leadership by example and supports the development of a strong and engaged clinical affairs department. Recommends and implements innovative ideas for continuous ... industry experience 4+ years of industry experience specifically in clinical project /program management, clinical trial...corporate goals and objectives Excellent working knowledge of GCP, clinical affairs , and regulatory affairs … more
- Beth Israel Lahey Health (Burlington, MA)
- …continuing education activities and attends conferences/seminars to maintain current knowledge of clinical study affairs and issues. Participates and assists in ... a difference in people's lives. Under general direction, the Research Program Manager will be responsible for managing, promoting, cultivating and overseeing all… more
- Exact Sciences (Boston, MA)
- …including, but not limited to sales, commercial development, medical affairs , IT, project management/implementation, billing, operations, to develop ... working to help others. Position Overview The Lead Pipeline Solutions Account Manager is responsible for implementing and managing strategic and tactical plans that… more
- Veterans Health Administration (Tulsa, OK)
- …They plan and carry out their work according to the schedule or project assignment, keeping within the framework of established gardening practices. Incumbent will ... program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP) Qualifications To qualify for...knowledge regarding a candidate's abilities; and assist a hiring manager with making a final selection for a position.… more
- UCB (Atlanta, GA)
- …are looking for a Global Regulatory Lead to join us in our Global Regulatory Affairs team, based in any of our Brussels (Belgium), Slough (UK) or Atlanta or Raleigh ... (US) offices. About the role The Global Regulatory Affairs Leader provides regulatory leadership tailored to the assigned...assigned projects and is a key member of the project team. Who you'll work with The role reports… more
- Bayer (Miami, FL)
- …Area Business Unit team; Presentations to internal audiences including Therapeutic Area Medical Affairs (MA) or commercial partners; Lead project teams or task ... healthcare clinical setting; or pharmaceutical industry experience in Medical Affairs , Sales, Marketing or Clinical Development; or post-graduate fellowship… more
- Abbott (Santa Clara, CA)
- …Abbott technologies in competitive markets. *Coordinate with Advertising & Promotion and Clinical Affairs teams to ensure compliant, evidence-based claims and ... serve people in more than 160 countries. JOB DESCRIPTION: Job Title Global Product Manager Working at Abbott At Abbott, you can do work that matters, grow, and… more
- Vera Therapeutics (Brisbane, CA)
- …Remote About Us: Vera Therapeutics (Nasdaq: VERA), is a late clinical -stage biotechnology company focused on developing treatments for serious immunological ... Operations team, this person will partner closely with Sales, Marketing, Medical Affairs , HR and Compliance to ensure a fully prepared and high-performing nephrology… more
- Veterans Health Administration (Detroit, MI)
- …influenza vaccination program is a requirement for all Department of Veterans Affairs Health Care Personnel (HCP). Qualifications To qualify for this position, ... You will be rated on the following Competencies for this position: Project Management Data Management Research Technical Competence Experience refers to paid and… more
- Kelly Services (South San Francisco, CA)
- **Kelly(R) Science & Clinical ** is seeking a Regulatory Affairs Manager for a direct-hire position at a cutting-edge client in South San Francisco, CA . If ... candidate is located in the West Coast.** The Regulatory Affairs Manager or Sr Manager ...identifies data and information requirements as needed by the project . + Key RA representative and leader on product… more
- Abbott (Sylmar, CA)
- …device and Cardiac Rythm Management solutions The Opportunity - We are seeking a Regulatory Affairs Project Manager to join our Cardiac Rythm Management team ... As an individual contributor, the function of a Regulatory Affairs Project Manager is to...**Premarket:** + Assess the acceptability of quality, preclinical and clinical documentation for submission filing + Compile, prepare, review… more
