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Resume alert |
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Berwyn, PA
... Responses to FDA queries IP claims and disclosures Clinical Study Reports (CSRs) Working on RAPS certification Presentations and posters Informed Consent Forms KEY ACCOMPLISHMENTS • Led publishing for 3 pipeline products, facilitating successful ...
- 2023 Nov 17
Philadelphia, PA
... Major Accomplishments: o Executed multiple FDA submissions for Vaccines and NS therapeutic areas. o Provided training and presentations to stakeholders and upper management on specifics of CBER requirements for Vaccines (SDSPs, Immunogenicity and ...
- 2023 Nov 16
Philadelphia, PA
... Ensure all data meets HIPAA, FDA, CFR Part 11, and GDPR regulations. Led hiring efforts for several key roles for Salesforce developers, Product Manager/Project Manager, Architect and Business Analyst.) Conduct Monthly 1 on 1 with for Salesforce ...
- 2023 Nov 13
Philadelphia, PA
... Director of Operations: TRD Trucking Vineland NJ July 2022 – February 2023 TEMPORARY POSITION Manage company of over 130 employees in Food Grade Tanker / Reefer Trailer / FDA regulated, KOSHER compliant trucking company. Manage team of 9 Driver ...
- 2023 Oct 24
Marlton, NJ
... Instrumental in facilitating internal and external audits, mentoring high-performing teams, and verifying compliance with cGMP and FDA standards. Skilled researcher with a solid understanding of synthesis patterns and properties determination. ...
- 2023 Oct 20
Mount Laurel, NJ
... Work with FDA on REMS assignments to ensure that the benefits of a Merck drug outweigh the risks associated with the drug. Bristol Meyers Squibb 10/17- 03/18 Global Procurement Buyer Princeton, New Jersey Strategic Sourcing Excellence Confer with ...
- 2023 Oct 13
Wenonah, NJ
... FDA-approved, all-natural cough/cold/sore throat drug brand (Biovanta) while at Applied Biological Laboratories, resulting in: o 25K+ points of distribution in the first 9 months of launch and 1200% sales growth during the latest cough/cold season. ...
- 2023 Oct 09
Moorestown, NJ
... ●Enforcing safety policies are followed as defined by OSHA, FDA, and cGMP guidelines ●Creating and overseeing employee training to increase production, using the LMS Bridge software enhance safe operations and ensure profitability and semi-automated ...
- 2023 Oct 08
Downingtown, PA, 19335
... approved, and launched on a timely basis Project Manager – Merck Oncology Performed project management and content development activities to create FDA OPDP submissions of oncology promotional assets to comply with FDA Subpart E regulations. ...
- 2023 Oct 02
Philadelphia, PA
... Knowledge of Kaizen project, 5 S projects, and business unit cell development Good knowledge of the application of FDA cGMP’s and cGLP’s on a yearly basis Experienced in both commercial and clinical manufacturing and packaging Knowledge of ...
- 2023 Sep 12