Company Overview

This biopharmaceutical company develops therapeutics for the treatment of liver disease.

Title: Medical Writer — JO#2207-5796

Therapeutic Area: Gastrointestinal

Territory: New Jersey, New York, Pennsylvania

The Medical Writer will be the lead on all documents in support of regulatory, clinical, journal, and conference publications. These assigned documents will be prepared in accordance with the Company’s Standard Operating Procedures (SOPs) and team member requirements per agreed timelines.

The Medical Writer collaborates with members of the Company’s 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.

Essential Duties and Responsibilities

• 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 multidisciplinary team members (regulatory, medical, statisticians, clinicians, data managers, and drug safety groups) 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.
• 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.

Qualifications (Education & Experience)

• A Bachelor's Degree (or higher) or an MS (or PhD) in 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 the 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 within and across documents.
• 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 medical terminology.
• Excellent attention to detail and accuracy.
• Demonstrates initiative and sound judgment when faced with less familiar project/document situations or challenges.

Since 2009, TriNet Pharma has evolved into one of healthcare’s largest and most respected agencies for recruiting and placing permanent and contract Medical Affairs, Clinical Affairs, Regulatory Affairs, and Medical Communications professionals in life sciences companies in the United States and around the world.