Director, Medical Writing

About AskBio
Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned and independently operated subsidiary of Bayer AG acquired in 2020, is a fully integrated AAV gene therapy company dedicated to developing life-saving medicines that have the potential to cure genetic diseases. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular and metabolic disease indications with a clinical-stage pipeline that includes therapeutics for Pompe disease, Parkinson’s disease and congestive heart failure, as well as out-licensed clinical indications for hemophilia and Duchenne muscular dystrophy. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, UK, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. Founded in 2001 and an early innovator in the gene therapy field, the company holds more than 850 patents in areas such as AAV production and chimeric and self-complementary capsids. Learn more at www.askbio.com.
Position Overview
The Director, Medical Writing (MW) will be responsible for the overall scientific leadership providing clinical direction to team members, developing and writing content for their specific projects as well as reviewing scientific content created outside AskBio. This position will have direct interaction with leading key opinion leaders. The Medical Writer is required to travel to project specific advisory board meetings, and at times, may be required to attend scientific congresses. Projects may include development of clinical content which includes case studies, text based and power point slides. Must be knowledgeable on the appropriate guidelines including, but not limited, to the ACCME Standards for Commercial Support, PhRMA Code, and OIG Guidance.

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!

Job Responsibilities
The Director, Medical Writing will:
  • 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.