Penfield Search Partners
Contact: Neisha Camacho/Terra Parsons – email@example.com
Job Description: The Medical Writing (MW) Lead(er) provides strategic leadership and operational direction to a growing team of medical writers. The primary responsibilities of this position are to advance the medical writing capabilities internally, establish strategies for document authoring, contribute scientifically at the project and/or study team level, manage CROs and external writers for document quality, and develop medical writing timelines, processes, and working standards. This role reports to the Head of Biometrics & Data Management and ensures the preparation of strategic, high-quality writing deliverables containing scientific justifications of company positions supported by relevant experience and evidence.
The successful candidate will possess advanced knowledge of NDA/BLA/MAA submissions, document management systems, relevant therapeutic areas, and other aspects of drug development (e.g., pharmacokinetics, biostatistics). S/he will make significant contributions to department initiatives and will collaborate with key functions across the organization to deliver crucial submissions to regulatory agencies.
- Provides leadership and strategy for document authoring at the organization level.
- Directs all Medical Writing activities within Clinical Development, including the planning and execution of robust outsourcing, resourcing, risk management and technology strategies that ensure the timely preparation and delivery of high-quality clinical and submission documents.
- Substantively contributes to document preparation to ensure that regulatory guidelines and overall document strategy are considered.
- Critically reviews medical writing deliverables for quality, scientific content, alignment with company position, clarity, accuracy, and consistency.
- Ensures objectives are met through initiation of a program of work (e.g., building a clinical submission), coordination of medical writing activities with functional area contributors, and document preparation, reviews, and approval.
- Provides guidance and direction for preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents.
- Establishes standards, as appropriate, and designs and implements systems, templates, or solutions to enhance efficiency, reduce expenditure and guarantee quality.
- Explore, evaluate, and recommend new technologies and procedures that would contribute to more efficient document preparation and improved document quality.
- Contributes to the development of key messages in consultation with subject matter experts and participates in requests for and review of data outputs to support document preparations for regulatory filings.
- Advise clinical development and clinical trial teams regarding ICH and GCP guidance and other regulatory requirements for medical writing deliverables. Leads the development and planning of document preparations to support BLA/NDA/MAA submissions.
- Has strong knowledge of the drug development process, global regulations, and guidelines.
- Possesses the ability to think strategically across a broad portfolio and effectively express views to influence senior management.
- Works with cross-functional project teams to develop project objectives, strategies, corresponding timelines, and milestones.
- Focuses on continuous improvement to apply expert knowledge of international regulations, requirements and guidelines that apply to the preparation and production of submission-ready documents.
- Expertise in developing and applying regulatory and company guidances, processes, and standards to ensure efficient quality, delivery, and compliance of clinical documents.
- Strong attention to detail with the ability to prioritize effectively and deliver results within reasonably established timelines.
- Ability to work well with vendors and build strong relationships with cross-functional teams.
Required Work Experience:
- Graduate degree in the life sciences preferred with a minimum of 5 years of experience managing writing activities, personnel, and projects for regulatory submissions
- Minimum of 15+ years of experience in the biopharmaceutical industry
- Advance understanding of the clinical development process including preparation of the documents required at each stage of development and experience with CTD submissions
- Expertise in ICH and GCP guidelines and global regulatory requirements sufficient to lead the development of medical writing SOPs, templates, and best practices to support the consistent preparation of high-quality clinical documents
- Successful track record of working collaboratively and leading through influence across global organizational matrices
- Understanding medical concepts in infectious disease is highly preferred