Director, Medical Writing
The Director, Medical Writing (MW) is also responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of a clinical program. This position requires an advanced knowledge of BLA/MAA submissions and working knowledge of and experience in document management systems.
We are excited about our next Director, Medical Writing to join the AskBio team!
- Align, coordinate, and build consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
- Analyze proposed plans, programs, individual studies, and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency. Develops clear, concise outlines, on-target first drafts, and proactively incorporates data/revisions
- Possess and utilize strong meeting planning & facilitation skills to convene document review roundtable meetings to gather, collate, and update and finalize draft documents to include pertinent information; in the absence of meetings, efficiently uses technology to circulate and finalize documents
- Determine resource needs, proactively identifies issues and solutions, and sets timelines and processes.
- Ensure statements included in the documents/deliverables are accurate and supported by appropriate data.
- Represent medical writing on the team level to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
- Work with other Medical Writing staff to develop a messaging strategy across a program of work
- Assess each project to proactively identify areas that will require assistance from others.
- Enhance clarity and grammatical accuracy of the writing while maintaining the voice/tone/thoughts of external authors
- Ensure scientific accuracy while editing and referencing
- Keep project team and manager apprised of project(s) status (through weekly status meetings or routine email communications) and challenges encountered during the project (e.g., changes in scope, delays in receiving comments)
- Direct line management of medical writing staff and indirect oversight of consultant or contract medical writers.
- Work with the SVP, Clinical Operations, will build an appropriate AskBio Medical Writing function.
Required Education & Experience
- PharmD or PhD in the life sciences preferred with at least 3-5 years regulatory medical writing experience OR minimum BA/BS in life sciences or higher and at least 6 years of regulatory medical writing and editorial experience in the pharmaceutical industry.
Preferred Skills & Experience
- Solid understanding of the clinical development process, including the documents that are required at each stage
- Exceptional verbal and written communication skills including the ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
- Expert Microsoft Office with a special focus on tables, spreadsheets, presentations, graphics, and templates.
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission.
- Proficiency in Internet and PubMed searches.
- Documented ability to think strategically with demonstrated negotiating skills and resourcefulness.
- Ability to manage several projects simultaneously.
- Strong influencing skills, able to lead without formal authority.
- Demonstrated ability to work collaboratively with multicultural sensitivity, build positive and productive relationships, seek input and value differences.
- Successful track record of leading complex clinical / regulatory writing projects.
- Excellent organizational and time management skills.
- Ability to work independently with minimal supervision, and as part of a team.
- Sense of curiosity and willingness to learn, as gene therapy is a fast paced, evolving area of research.