Senior Manager, Medical Writing
Direct Hire for Full Time Placement, Princeton, NJ
The Senior Manager, Medical Writing, is expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects. The “hands-on” Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. The responsibilities also include the coordination and preparation of Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following:
• Prepare/coordinate and deliver high quality clinical sections of submission (IND/NDA/CTD) and responses to regulatory authorities, and implement medical writing activities. Interact with multi-disciplinary team members (regulatory, physicians, 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 do the needed writing and pull together the documents in an efficient, non-disruptive manner for submissions to regulatory authorities.
• Prepare/coordinate clinical documents as required (e.g., Clinical Trial Reports (Phase I – IV) and associated appendices, Investigator’s Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, Clinical Expert Statements, clinical sections of IND/NDA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary.
• Manage the activities of internal/external resources and medical writing vendors (i.e., individual consultant medical writers and contract research organization (CRO) medical writers).
• Managing projects within pre-defined budget, pre-defined internal resources and time constraints
EDUCATION and/or EXPERIENCE REQUIRED:
• B.S. degree, advanced degree/Life Sciences preferred.
• 7- 10 years experience in regulatory writing within the pharmaceutical industry, including managing 3-4 global registration dossiers.
• Experience with diagnostic imaging agents preferred.
• Experience working with an electronic based document management system.
• Vendor/consultant management experience preferred.
• Experience with interactions with regulatory groups and formulating regulatory strategies desirable.
Contact: Laura Walton, firstname.lastname@example.org