Senior Medical Writing Expert

2 weeks ago


San Diego, California, United States Trova Talent Full time
Job Title: Senior Medical Writing Expert

Job Summary:

Trova Talent is seeking a highly skilled Senior Medical Writing Expert to join our team. As a key member of our medical writing team, you will be responsible for creating high-quality clinical regulatory documents for Investigational New Drug (IND) Applications/Clinical Trial Applications (CTA's) and BLA's/Marketing Applications for biotechnology products and cell therapies.

Key Responsibilities:

* Lead the preparation of clinical regulatory documents, including clinical study reports, Investigator's Brochure, safety updates and reports, and clinical/nonclinical summaries tabulations and overviews for US and ex-US regulatory submissions.

* Provide strategic guidance for study teams on document creation and submission.

* Collaborate with cross-functional team members to ensure accurate and timely completion and/or delivery of high-quality, scientifically justified documents.

* Identify pertinent internal and external sources of clinical/nonclinical data and conduct literature searches of peer review publications to prepare documents.

* Ensure the scientific accuracy and regulatory quality assurance of developed content and deliverables.

Requirements:

* Bachelor's degree in a scientific or medical field.

* 10+ years of experience in medical/technical writing in the Biotech/Pharmaceutical industry.

* Experience in the preparation of clinical/preclinical sections and/or documents for INDs and/or NDAs/BLAs in eCTD format.

* Understanding of clinical research, drug development process, and applicable FDA and ICH guidelines.

* Knowledge of eCTD content/format requirements.

* Understanding of Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs), and Good Manufacturing Practices (GMPs).

* Ability to read, analyze, and interpret scientific, technical data, and regulatory guidelines and regulations.

What We Offer:

* Opportunity to work with a leading talent acquisition company.

* Collaborative and dynamic work environment.

* Competitive salary and benefits package.

How to Apply:

If you are a motivated and experienced medical writer looking for a new challenge, please submit your resume and cover letter for consideration.

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