Medical Writer – 100% FULLY REMOTE Jobs in San Francisco, CA at Actalent
Title: Medical Writer – 100% FULLY REMOTE
Location: San Francisco, CA
100% Fully Remote Medical Writer Job Opportunity!!*
Description:* The Medical Writer collaborates with members of Hepion cross-functional teams and vendors to prepare high-quality protocols, investigator brochure updates, synopses, clinical study reports, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines
Key Activities:* → Prepare/coordinate clinical and regulatory documents as required e.g., Clinical Trial
Protocols, Clinical Trial Reports (Phase I – III) with associated appendices, Investigator
Brochure, Patient Informed Consents, and Drug Safety-related documents such as
Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs). → Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. Interact with multi-disciplinary team members (regulatory, medical, statisticians, clinicians, data managers and drug safety group) as applicable.
Discuss the objectives, timelines, and documents to be generated, coordinate contributions from other groups and prepare the documents in an efficient manner for submissions to regulatory authorities. → Resolve conflicting comments among reviewers. → Manage projects within time constraints. → Provide status reports for ongoing projects. → Act as a Medical Writing coordinator for the preparation of Drug Safety-related documents such as PSUR/PBRERs. Secondary Activities, Duties, Tasks and Responsibilities → Review medical documents generated outside of Medical Writing (e.g., study protocol,
Statistical Analysis Plan, tables and listings). → Prepare/review SOPs, Working Guides, and document templates
Skills:* Medical writing, Regulatory, Clinical trial, protocol, Drug Development, NDA, clinical study report, regulatory documents, ind, ectd
Additional Skills & Qualifications:* → A Bachelor’s Degree (or higher) or an MS (or PhD) in a clinical/medical science is strongly preferred. Relevant professional certifications are a plus. → 6+ years of relevant industry experience and related competency levels including acting as lead writer for clinical study reports and clinical study protocols and investigator brochures.
→ In-depth knowledge of the structural and content requirements of clinical and regulatory documents and the ability to identify deficiencies, errors, and inconsistencies with in and across documents.
Additional Skills, Qualifications and Professional Experience:* → Understanding of clinical research, the drug development process, and industry guidelines and regulations, ICH and GCP → Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge and ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel) → Ability to integrate, interpret, and summarize data from a variety of sources in a clear concise manner. → Good understanding of statistical principles and of medical terminology. → Excellent attention to detail and accuracy. → Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges
Experience Level:* Intermediate Level
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