Director Medical Writing

• 5000 - 6000 USD per Month
• Full Time
• Posted : 10 months ago

Role Summary

• The Medical Writer (Director-Professional Track) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
• Understands the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.
• Demonstrates subject matter expertise of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues. Takes appropriate risk to resolve any identified issues.
• Is a subject matter expert in clinical regulatory writing and has advanced knowledge of other functional areas who can represent the Medical Writing group on internal cross-functional initiatives.
• Is facile with innovative problem solving, peer influence, and change management.

• Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance. Demonstrates subject matter expertise.
• Provides strategic and operational leadership to direct preparation and completion of documents. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Drives decision making about data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents. Contributes to the development of asset- or therapeutic area-level conventions.
• Develops and maintains project timelines. Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
• Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
• Aligns with department management to set strategy for meeting department goals.
• Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line. Leads process improvement initiatives within Medical Writing and may lead cross-functional initiatives to support operational efficiency, quality, and innovation.
• If leading a team of other writers, coordinates efforts of all writers to achieve timely delivery of high-quality, fit [1]for-purpose documents to the project team.
• If assigned by manager, serves as the Medical Writing ‘point of contact’ for all document issues for a given asset or set of assets.

• Bachelor’s degree, preferably in a life science discipline.
• BS/BA + extensive experience in medical writing or related field.
• MS/MA + extensive experience in medical writing or related field.
• PhD + strong experience in medical writing or related field.
• Understanding of the role of each member of cross-functional team.
• Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
• Ability to manage documents of greater complexity and/or variety.
• Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
• Adapts to change as needed.
• Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
• Ability to identify complex problems that require management or cross-functional input for resolution in timely manner
• Develops innovative options or multiple solutions to resolve complex problems that impact project completion and/or document content strategy. Demonstrates critical and rapid decision-making.
• Ability to mentor more junior colleagues.
• Proven experience in a project management role, leading a team or function.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
• Ability to lead cross-functional peers across therapeutic areas for improving a process, not limited to medical writing.
• Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function. Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.
• Serves as an authority on global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data.
• Advises team on interpretation of global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data.
• Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.
• Advanced understanding of medical concepts of the disease and current standard treatments as well as other investigational treatments.
• Extensive understanding of place of product benefit/risk in commercial and medical setting.
• Analytic skills. Ability to examine data and formulate reasonable hypotheses.
• Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.
• Language skills. High fluency in spoken and written English.
• Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
• Able to consolidate, analyze, interpret, and summarize data from multiple data sources, including the global safety database, with no supervision.

• Advanced degree (MS/MA/PhD) is preferred.
• Demonstrable experience in Medical Writing with experience of marketing application submissions (NDAs and MAAs, associated pivotal CSRs) is preferred.
• Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.

Skills

• Medical Writing
• Content Writing
• life science
• project management skills
• Communication