| Resume alert | Resumes 41 - 50 of 542 |
Infectious Diseases Communication Skills
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
... 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
Associate Director Statistical Programming
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
... 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
Project Manager Management
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
... 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
Medical Writing Quality Control
Pottstown, PA
... Regulatory Submissions Manager with BRIO Consulting Group Worked on migration and clean-up project of MedWatch forms (FDA 3500A) and other safety reports (PSURs, etc.) Pfizer, Inc., Collegeville, PA November 2010 – April 2012 Consultant for ... - 2023 Nov 11
... Regulatory Submissions Manager with BRIO Consulting Group Worked on migration and clean-up project of MedWatch forms (FDA 3500A) and other safety reports (PSURs, etc.) Pfizer, Inc., Collegeville, PA November 2010 – April 2012 Consultant for ... - 2023 Nov 11
Otr Flatbed Vice President
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
... 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
Project Management Medical Education
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
... 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
Customer Service Quality Assurance
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
... 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
Quality Analyst
Lansdale, PA
... Skilled in general orthopedic instruments and routinely contributes to submitting medical device reports (MDR) to the FDA. Professional Experience: Millenium Software, Inc- Olympus America, Inc. August 2023 – Present Quality Analyst Using Pivot ... - 2023 Sep 03
... Skilled in general orthopedic instruments and routinely contributes to submitting medical device reports (MDR) to the FDA. Professional Experience: Millenium Software, Inc- Olympus America, Inc. August 2023 – Present Quality Analyst Using Pivot ... - 2023 Sep 03
Project Manager General
Philadelphia, PA
... Ensured compliance with regards to US Government regulatory agencies such as FDA, EPA, FCC, Fish & Wildlife, etc. Coordinate shipping details with various steamship carriers. I have spent a few months twice helping out in this department when Air ... - 2023 Sep 01
... Ensured compliance with regards to US Government regulatory agencies such as FDA, EPA, FCC, Fish & Wildlife, etc. Coordinate shipping details with various steamship carriers. I have spent a few months twice helping out in this department when Air ... - 2023 Sep 01
Director, North America Real Estate, Facilities, & Maintenance
Lansdale, PA
... Belt Certified, Green Belt, Inclusion Behavior, Leadership Boot Camp, CPR/AED Certified, cGMP / GxP/ FDA Inspection, Gemba walk., MCR Candidate, Change Management, Portfolio Management, Enterprise Alignment, CRE Finance, Sustainable Strategies - 2023 Aug 27
... Belt Certified, Green Belt, Inclusion Behavior, Leadership Boot Camp, CPR/AED Certified, cGMP / GxP/ FDA Inspection, Gemba walk., MCR Candidate, Change Management, Portfolio Management, Enterprise Alignment, CRE Finance, Sustainable Strategies - 2023 Aug 27