| Job alert | Jobs 61 - 70 of 432 |
Executive Director Regulatory Strategy
The Newsome Group
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Lexington, MA
... all regulatory activities Experience required with preparing regulatory documents including new INDs, safety reports, Investigator Brochures, DSURs, briefing packages, pediatric study plans and documents for other regulatory submissions Experience ... - Jun 25
Principal Scientist, Analytical Science & Technology, Cell Therapy
Bristol Myers Squibb Company
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Ayer, MA, 01432
... Must be able to function independently as the lead investigator and lead analytical investigations. Experience with implementing bioassay/potency methods in a commercial QC facility is required. Demonstrated experience in method lifecycle management ... - Jun 23
Associate Director or Director, GCP Quality Assurance
Apnimed
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Cambridge, MA, 02140
... The position is accountable for the execution of Quality Assurance (QA) audit and inspection activities for assigned sponsor, investigator sites, vendors and IRB & Ethic committees in preparation for BIMO inspections. This role is responsible for ... - Jun 21
Senior Director - Clinical Pharmacology
Novo Nordisk
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Lexington, MA
... Summary and other documents with clinical pharmacology such as Investigator’s Brochure and Health Authorities interactions in line with strategy Attend and negotiate clinical pharmacology aspects at internal and external meetings with e.g. ... - Jun 11
Clinical Trial Associates / Sr. Clinical Trial Associates (2)
Cardurion Pharmaceuticals, Inc
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Burlington, MA, 01803
... Participates in the development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials Organizes, leads, and manages internal team meetings, investigator ... - Jun 26
Clinical Project Manager, Clinical Operations
Replimune Group, Inc.
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Woburn, MA, 01813
... * May oversee investigator recruitment/ selection across project. * Ensure study staff is appropriately trained on relevant guidelines, regulations and SOPs. * Participate in ad hoc clinical operations' initiatives and programs. * Contribute to ... - Jun 22
Clinical Research Coordinator
US Tech Solutions
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Malden, MA, 02148
... Responsibilities: · Function as participants’ primary point of contact, keeping them informed on the study progress, and facilitate involvement of other study team members, as needed (e.g., notify Principal Investigator of safety events) · Manage ... - Jun 02
Senior Clinical Trial Associate
Lantheus
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Bedford, MA
... Responsibilities include generation of progress tracking reports, trial specific system set-up and access management, system data entry, meeting arrangement / minute capture, document management, and investigator meeting set-up and coordination. The ... - Jun 27
Medical Information Scientist, Medical Affairs
Orchard Therapeutics
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Boston, MA, 02203
... use) requests Other expanded access requests · Processes for the review of external scientific and medical grant requests Investigator-initiated study (IIS) / investigator-initiated trial (IIT) grants Unrestricted medical education grants Continuing ... - Jun 22
Sr. Medical Director, Global Drug Safety
Replimune, Inc.
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Woburn, MA
... Review and provide input on study protocols, statistical analysis plans, safety content of informed consent documents, Investigator and site training documents and presentations Contribute to CSRs and analysis of safety tables, figures, and listings ... - Jun 21