Corporate Medical Writer, Senior Manager: Quest Solutions Group

Job Title: Senior Manager, Corporate Medical Writing

Reports To: Executive Director, Corporate Medical Biometrics and Medical Writing

Duties and Responsibilities:

• Serve as the medical writing (MW) representative on Project Teams.
• Provide input to the development of strategy for multinational clinical activities associated with registration and market support of a product.
• Review medical documents generated outside of MW (e.g. Study Protocols, Statistical Analysis Plans, Tables and Listings).
• 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 sections of IND/IMPD/NDA/MAA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary.
• Prepare/coordinate clinical sections of submission (IND/IMPD/NDA/MAA//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 pull together the documents in a efficient, non-disruptive manner for submissions to regulatory authorities.
• Manage the activities of internal/external resources and medical writing vendors (i.e. individual consultant medical writers and contract research organization (CRO) medical writers).
• Prepare/review SOP’s and document templates.
• Manage projects within pre-defined budget, pre-defined internal resources and time constraints
• Providing status reports for ongoing projects

Core Competencies:

• Demonstrated medical writing skills and high level interpersonal skills to interact effectively within team and matrix work settings. Sensitivity to cultural differences.
• Excellent written/oral communication skills and highly proficient word processing skills.
• Working knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.
• Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
• Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers.
• Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, with proven analytical and problem solving abilities.

Education and/or Experience Required:

• B.S. degree, advanced degree/Life Sciences preferred.
• 7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including managing 2-3 global registration dossiers.
• Experience with contrast medical and imaging modalities preferred.
• Experience with an electronic based document management system.
• Vendor/consultant management experience preferred

Other:

• International travel, generally to European countries required, approx. 15%.