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FDA jobs in Somerville, MA

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Job alert Jobs 31 - 40 of 744

Sr Director / Executive Director Regulatory Strategy

The Newsome Group  –  Lexington, MA
... requirements in line with corporate objectives and timelines Serve as an influential and well-respected spokesperson with staff at FDA/EMA and other Health Authorities, including leading meetings and preparations to facilitate expedited approval of ... - Aug 28

Clinical Services Manager (Non-Clinical - Administrative)

LHH Recruitment Solutions  –  Boston, MA, 02110
... clinical pharmacology programs for small molecule therapeutics • Strong knowledge of PK/PD principles, ADME concepts and FDA Office of Clinical Pharmacology regulatory guidances • Prior NDA submission experience (CTD Sections 2.7.2, 2.7.2, 2.5) • ... - Sep 10

Medical Lab Scientist

Mass General Brigham  –  Cambridge, MA, 02140
... The MGH Blood Bank is an FDA-licensed, AABB-accredited full-service facility that issues over 70,000 blood components annually. We are committed to delivering the highest quality and safest care possible for every patient. Consider joining our team! ... - Sep 18

Head of Quality Control

Sci-Rec  –  Boston, MA, 02298
... Demonstrate knowledge of cGMP requirements and practices including extensive knowledge of the USP and FDA Guidance Documents relating to the pharmaceutical Quality Control Laboratory; Demonstrate competency in the operation, calibration and ... - Sep 07

Quality Assurance Manager

ACE Partners  –  Lowell, MA
... Knowledge of ISO 13485, FDA 21 CFR 820, EU MDR, CAPA, and customer complaints. Experience with Class II/III medical devices and manufacturing process tools (FMEA, Risk Management, Process Validation). Preferred: Quality certifications (ASQ, Lead ... - Sep 19

staff - Registered Nurse (RN) - Manager

Mass General Brigham  –  Boston, MA, 02298
... The Flow Manager is accountable for direct oversight of staff to ensure compliance with cGMP, FDA and AABB standards. Functions as a super-user of donor center IT systems and works the Blood Bank IT team to address issues. Works with mobile drive ... - Sep 18

Medical Lab Scientist

Mass General Brigham  –  Medford, MA, 02153
... The MGH Blood Bank is an FDA-licensed, AABB-accredited full-service facility that issues over 70,000 blood components annually. We are committed to delivering the highest quality and safest care possible for every patient. Consider joining our team! ... - Sep 18

Vice President Medical Affairs

ARTO  –  Boston, MA, 02298
... Qualifications: MD (Board-certified Neurologist preferred) Proven track record in Medical Affairs leadership, team building, and growth strategy implementation Product launch experience, ideally in neuromuscular diseases Prior engagement with FDA ... - Sep 22

Medical Lab Scientist

Mass General Brigham  –  Everett, MA, 02149
... The MGH Blood Bank is an FDA-licensed, AABB-accredited full-service facility that issues over 70,000 blood components annually. We are committed to delivering the highest quality and safest care possible for every patient. Consider joining our team! ... - Sep 18

Sr. Manager, Clinical Science

The Steely Group  –  Cambridge, MA, 02138
... Knowledge of International Conference of Harmonization (ICH), Good Clinical Practice (GCP), Food and Drug Administration (FDA) regulations and other guidelines. Strong data analysis and problem-solving skills. Excellent communication and ... - Sep 19
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