- J&J Family of Companies (Raynham, MA)
- …PROCESS SUPPORT** + Work with cross-functional partners, including but not limited to R&D, Clinical Affairs , Regulatory Affairs , Health Economics & ... potential patient safety issues. This position involves cross-functional collaboration with Clinical Affairs and HEMA teams generating and disseminating… more
- J&J Family of Companies (Cincinnati, OH)
- …products/solutions. + Work with business partners including but not limited to R&D, Clinical Research, Regulatory Affairs , Communications, Legal, Quality & ... to provide leadership with product development, pre- and post-approval clinical studies, regulatory approval/clearance, downstream claims, safety assessments,… more
- Kelly Services (Bridgewater, NJ)
- ** Regulatory Affairs Generalist** Kelly Science and Clinical is seeking a ** Regulatory Affairs Generalist** **for** our client a leading medical ... from subject matter experts in nonclinical, clinical , and medical affairs . + Provide operational and administrative regulatory writing (cover letters,… more
- Bausch Health (Bothell, WA)
- …clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations/studies + Regulatory affairs professionals ... and values drive our collective progress and impact. The Manager, Regulatory Affairs will be responsible for: + Responsible for developing and implementing… more
- Danaher Corporation (New York, NY)
- …are met on time and within budget. Work closely with internal teams such as clinical research, regulatory affairs , marketing, and sales to integrate medical ... address the world's biggest health challenges. The Regional Medical Affairs Lead, Neurology, for Beckman Coulter Diagnostics is responsible...This position is part of the Medical & Scientific Affairs located in the United States and will be… more
- Sanofi Group (Morristown, NJ)
- …mentor talent within the organization **Cross-functional Collaboration:** + Work closely with clinical development, regulatory affairs , market access, and ... **Job Title:** Head of Global Medical Affairs , Solid Tumors **Location** : Cambridge, MA, Morristown,...join our team as the Head of Global Medical Affairs for Solid Tumors. This role will be pivotal… more
- Kelly Services (Valencia, CA)
- …$100,000-$140,000/year (DOE) + **Industry:** Medical Device / Life Sciences Kelly(R) Science & Clinical is hiring a ** Regulatory Affairs Manager** for a ... + ** Regulatory Affairs Manager** + **Location:** Onsite...of future opportunities in the field of science and clinical research. **Join us in making a difference by… more
- Takeda Pharmaceuticals (Boston, MA)
- …industry with direct leadership experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical ... tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory is… more
- Vera Therapeutics (Brisbane, CA)
- …complete regulatory content that meets current regional requirements * Represent clinical Regulatory Affairs on cross-functional project teams * Evaluate ... Title: Senior Manager, Clinical Regulatory Location: Brisbane, California About...communicating regulatory strategies to stakeholders * Demonstrated Regulatory Affairs experience commensurate with the role… more
- Bristol Myers Squibb (San Diego, CA)
- …of study-related information. This role will work cross-functionally with several departments ( Clinical Operations, CMC, Regulatory Affairs , Supply Chain, ... team members both within medical affairs as well as clinical development, clinical operations, regulatory , legal, etc + Collaborate with operations to… more
- Beth Israel Lahey Health (Boston, MA)
- …Word, Excel, PowerPoint or Access. **Preferred Qualifications:** + 1-3 years of clinical trial regulatory affairs experience preferred. **Competencies:** ... in people's lives.** The Regulatory Specialist supports regulatory compliance for clinical research at Beth...Qualifications:** + Bachelor's degree required; Master's degree preferred in Regulatory Affairs . + 1-3 years related work… more
- Minnesota State (St. Cloud, MN)
- …+ Bachelor's Degree + Minimum of ten years of applicable industry experience in Regulatory Affairs , Clinical Research, Quality or Reimbursement + Advanced ... specified Closing Date (if designated).** **Working Title:** Adjunct Instructors - Regulatory Affairs and Services **Institution:** St. Cloud State University… more
- J&J Family of Companies (Horsham, PA)
- … Affairs in various interactions with the global functions including clinical R&D, translational medicine, regulatory affairs /labelling, and global ... or Immunology industry experience, including in clinical research/ clinical trials is highly preferred; Medical Affairs ...Ability to communicate clearly and effectively with basic and clinical scientists, as well as with regulatory … more
- Otsuka America Pharmaceutical Inc. (Helena, MT)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+ ... value and real-world evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies and cohesive medical… more
- System One (Park Ridge, NJ)
- …closely with clinical development teams, including clinical scientists, clinical affairs , regulatory affairs , biostatistics, physicians, and ... Title: Sr Regulatory Writer - R&D Location: Park Ridge, NJ... affairs , to ensure alignment and accuracy of clinical documents. + Actively facilitates internal reviewer comment reconciliation… more
- Bausch Health (Bridgewater, NJ)
- … regulatory standards. The ideal candidate will work cross-functionally with Clinical Development, Regulatory Affairs , Biostatistics, and Medical Writing ... + Around 10 years of experience in clinical development, clinical research, or regulatory affairs within the pharmaceutical or biotechnology industry. +… more
- Abbott (Pleasanton, CA)
- …Failure. We have an exciting opportunity for the right candidate to join our Global Clinical and Regulatory Affairs team within the Heart Failure Division ... for heart failure by collaborating closely with internal stakeholders (R&D, Marketing, Clinical Affairs , Medical Affairs , Reimbursement) and external… more
- Abbott (Alameda, CA)
- …priorities, and to be flexible when priorities change. + Working knowledge of GCP, Clinical and Regulatory Affairs . + Proficient with Microsoft Suite. The ... company guidelines. + Tracks, routes, and files Financial and regulatory documents in designated area. + Track clinical...approvals. + Review and approve invoices related to ongoing clinical projects. + Communicate clinical affairs… more
- Astrix Technology (Houston, TX)
- …+ Drive clinical program strategy in collaboration with cross-functional leaders in Clinical Development, Regulatory Affairs , Medical Affairs , and ... performance, identify risks, and implement mitigation strategies. + Contribute to clinical development plans, protocols, and regulatory submissions (INDs, NDAs,… more
- Organon & Co. (Sacramento, CA)
- …work collaboratively with cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing ... Investigator Brochures, briefing books, IND subsections, submission modules and other regulatory documents. + Provide clinical pharmacology subject matter… more
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