| Job alert | Jobs 51 - 60 of 838 |
Associate Director, Biostatistics
Sarepta Therapeutics
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Cambridge, MA
... activities in support of IND/NDA/MAA or other regulatory submissions Addresses statistical questions/comments from FDA and other regulatory agencies, and reviews and addresses comments by IRB/ECs Supports and contributes to the preparation ... - Jun 08
Director, Regulatory CMC iPSC Derived Cellular Therapies
ERAPS B.V.
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Cambridge, MA, 02142
... Comprehensive knowledge of regulatory (FDA. EMA, Health Canada and ICH) guidelines Experience with development and/or improvement of department processes/procedures Proven ability to impact and influence the decisions of a team and decision-making ... - Jun 14
Senior Statistical Programmer
Sarepta Therapeutics
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Cambridge, MA
... • Knowledge of CDISC standards for SDTM and ADaM and FDA electronic data submission requirements. • Familiarity with FDA and ICH regulations and guidelines. • Excellent problem-solving skills. • Good written and verbal communication skills and ... - Jun 14
Clinical Trials Associate
Monte Rosa Therapeutics, Inc
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Boston, MA
... Working knowledge of ICH/GCP guidelines and FDA regulations Ability to collaborate effectively with cross functional team members and external partners Strong organizational and time management skills, including the capacity to work independently ... - Jun 18
Director, Clinical Operations
Monte Rosa Therapeutics, Inc
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Boston, MA
... Extensive knowledge and application of current FDA Regulations, ICH/GCP guidelines in clinical trials. Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project/Smartsheet. Outstanding ability to communicate in an ... - May 29
Senior Director, Clinical Data Management
Leap Therapeutics
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Cambridge, MA, 02140
... Demonstrated understanding of regulations and guidelines (e.g., ICH, GCP, FDA, Privacy rules [HIPAA], etc.). Ability to work in a cross-functional team-oriented environment. Ability to read, analyze and interpret complex technical documents. ... - Jun 18
Regulatory Affairs Consultant - IVD
MDC Associates
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Beverly, MA, 01915
... Responsibilities Providing regulatory guidance and developing strategy to support Client/Sponsor regulatory and market objectives Developing FDA Q-subs in collaboration with clients (Pre-subs, Breakthrough, STeP) Provide input on content of ... - Jun 18
Senior Mechanical Engineer
CRB
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Boston, MA
... design · Intermediate experience with using and applying other applicable industry standards (ASHRAE, SMACNA, ISPE, FDA, ISO, NFPA, OSHA, etc.) · Advanced experience conducting and leading field surveys of existing conditions and support of ... - Jun 06
Class B CDL Driver
North Coast Seafoods
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Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 07
Class A CDL Driver
North Coast Seafoods
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Boston, MA
... manipulation, pushing and pulling Work requires the following motions: bending, twisting, squatting and reaching Exposure to FDA approved cleaning chemicals Exposure to temperatures: <32 degrees Fahrenheit Ability to work in wet and dry conditions ... - Jun 07