Associate Director/Director Of Medical Writing

Position: Associate Director/Director of Medical Writing
This key role is involved in the preparation of clinical regulatory documents included in Investigational New Drug (IND) Applications/Clinical Trial Applications (CTA’s) and BLA’s/Marketing Applications for biotechnology products and cell therapies.

REQUIREMENTS:

• Bachelor’s degree (B.A. /B.S.) in 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 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.
• Proficiency in Adobe Acrobat, Microsoft Office (Word, Excel, Power Point, Outlook).
• Ability to work independently or as part of a team; displays a commitment to service, be process oriented, and have a sense of urgency balanced with good judgment
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
• Ability to prioritize multiple and changing responsibilities while being organized & detail oriented.
• Strong integrity and work ethic are critical.
• Able to anticipate problems.

• Serving as the lead MEDICAL WRITING expert for regulatory clinical/nonclinical documents and manuscripts for publications with responsibility for on-time delivery of high-quality documents;
• Providing strategic guidance for the study teams as it relates to document creation/submission;
• Leading the overall strategy and execution OF MEDICAL WRITING projects in support of therapeutic development programs in collaboration with clinical/regulatory leadership;
• Writing and editing key clinical/nonclinical documents such as the clinical protocol, clinical study reports, Investigator’s Brochure, safety updates and reports, clinical/nonclinical summaries tabulations and overviews for US and ex-US regulatory submissions such as IND’s, CTA’s, BLA’s, MAA’s, briefing books for regulatory meetings, Orphan Drug Designation requests, Pediatric Study Plans, etc. or for in-company use;
• Oversight of junior medical writers and/or consultant medical writers and overall responsibility for managing externally-authored MEDICAL WRITING content, as needed;
• Communicating high-level clinical trial strategy vision in a document such a protocol or report;
• Collaborating with cross-functional team members to ensure accurate and timely completion and/or delivery of high-quality, scientifically justified documents;
• Identifying pertinent internal and external sources of clinical/nonclinical data and conducts literature searches of peer review publications to prepare documents;
• Ensuring the scientific accuracy and regulatory quality assurance of developed content and deliverables;
• Implementing and communicating deliverables needed, MEDICAL WRITING review processes, and timelines to team members as needed;
• Contributing to the development and standardization of templates and related processes and assist in the development of templates, style guides, and SOPs for regulatory writing;
• Maintaining expert knowledge of US and international regulations, requirements and guidance associated with clinical/nonclinical, regulatory, and safety document preparation and submissions;
• Leading and managing comment resolution meetings;
• Learning and applying knowledge of therapeutic area and product to scientific writing projects;
• Developing, maintaining, and driving document finalization timelines and coordination of document reviews;
• Leading and/or contributing to process improvement initiatives; and
• Performing such other duties as may be assigned to you from time to time.