Jeffrey Benezra Email & Phone Number | A Research and Development (R&D) professional with 25 years of experience in the pharmaceutical industry. Authored over 200 nonclinical regulatory submission documents, including first-in-human (FIH) INDs, CTA/IMPDs, IBs, and NDA/MAAs. Currently, a preclinical submission writer within Drug Safety Research and Development (DSRD) at Pfizer Inc. Provide DSRD regulatory strategy and submission writing support for FIH and late-stage portfolio programs for small molecules, biopharmaceuticals, and vaccines. Collaborate with cross-disciplinary project teams to establish scientific content and position, regulatory strategy, and timing of submission deliverables. Identify and facilitate resolution of scientific and regulatory issues. Previously, performed a similar function within Drug Safety and Metabolism (DSM) at Wyeth Pharmaceuticals. Initially a staff writer, but was awarded promotions to senior level writer, manager, and Preclinical Writing Leader as a result of increasing responsibilities and demonstrated competency and leadership. Chosen as the writer for the preclinical section of the first common technical document (CTD) NDA submitted by Wyeth Pharmaceuticals. Previously, an information technology professional within DSM. Developed guidance and implemented pragmatic, best practices for validation and GLP compliance of laboratory computer systems within DSM; accomplished the same for the implementation and management of electronic records and electronic signatures. These accomplishments were recognized by senior level management and were adopted across all of R&D within Wyeth Pharmaceuticals. Prior to Wyeth Pharmaceuticals, 7 years of R&D experience in the medical device industry. As a bench scientist, developed diagnostic methods and reagents for clinical laboratory systems; patented a novel hemoglobin method for a state of the art, automated hematology diagnostic system. Specialties: Medical Writing: Regulatory submissions including NDA, MAA, IND, IMPD, IB, IND Safety Report, IND Annual Report, Board of Health Response. Written and tabulated summaries of safety pharmacology, pharmacokinetics, and toxicology information, and nonclinical overview. FDA GLP regulations, ICH guidelines, eCTD document format. Technical Writing: Computer software development life cycle documentation with an emphasis on software validation planning, execution, and reporting.

Jeffrey Benezra

A Research and Development (R&D) professional with 25 years of experience in the pharmaceutical indu...
New York, New York, United States

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Jeffrey Benezra’s Email jeffrey.benezra@pfizer.com

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Jeffrey Benezra’s Location New York, New York, United States

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Jeffrey Benezra’s Prior Industry Wyeth | Taratec Development | American Cyanamid

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Work Experience

Pfizer

Regulatory Submission Scientist

Present

Wyeth

Preclinical Writer/Leader

2001-01-01 00:00:00 - 2010-01-01 00:00:00

Taratec Development

Senior Validation Consultant

1995-01-01 00:00:00 - 1996-01-01 00:00:00

American Cyanamid

Information Scientist/Group Leader

1987-01-01 00:00:00 - 1995-01-01 00:00:00

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FAQ About Jeffrey Benezra

Jeffrey Benezra is located at
New York, New York, United States

Jeffrey Benezra is a A Research and Development (R&D) professional with 25 years of experience in the pharmaceutical industry. Authored over 200 nonclinical regulatory submission documents, including first-in-human (FIH) INDs, CTA/IMPDs, IBs, and NDA/MAAs. Currently, a preclinical submission writer within Drug Safety Research and Development (DSRD) at Pfizer Inc. Provide DSRD regulatory strategy and submission writing support for FIH and late-stage portfolio programs for small molecules, biopharmaceuticals, and vaccines. Collaborate with cross-disciplinary project teams to establish scientific content and position, regulatory strategy, and timing of submission deliverables. Identify and facilitate resolution of scientific and regulatory issues. Previously, performed a similar function within Drug Safety and Metabolism (DSM) at Wyeth Pharmaceuticals. Initially a staff writer, but was awarded promotions to senior level writer, manager, and Preclinical Writing Leader as a result of increasing responsibilities and demonstrated competency and leadership. Chosen as the writer for the preclinical section of the first common technical document (CTD) NDA submitted by Wyeth Pharmaceuticals. Previously, an information technology professional within DSM. Developed guidance and implemented pragmatic, best practices for validation and GLP compliance of laboratory computer systems within DSM; accomplished the same for the implementation and management of electronic records and electronic signatures. These accomplishments were recognized by senior level management and were adopted across all of R&D within Wyeth Pharmaceuticals. Prior to Wyeth Pharmaceuticals, 7 years of R&D experience in the medical device industry. As a bench scientist, developed diagnostic methods and reagents for clinical laboratory systems; patented a novel hemoglobin method for a state of the art, automated hematology diagnostic system. Specialties: Medical Writing: Regulatory submissions including NDA, MAA, IND, IMPD, IB, IND Safety Report, IND Annual Report, Board of Health Response. Written and tabulated summaries of safety pharmacology, pharmacokinetics, and toxicology information, and nonclinical overview. FDA GLP regulations, ICH guidelines, eCTD document format. Technical Writing: Computer software development life cycle documentation with an emphasis on software validation planning, execution, and reporting.