Associate Director Medical Writing
We are a gene therapy company changing lives with every genetic advancement.
Asklepios BioPharmaceutical, Inc. (AskBio) is a leading, clinical-stage gene therapy company founded in 2001 based on the work of adeno-associated virus (AAV) gene therapy visionary and pioneer, Jude Samulski, PhD. Since that time, our commitment to developing life-saving medicines that cure genetic diseases has never wavered.
As the only end-to-end gene therapy company in the industry, we’ve built a foundation of therapeutic programs, AAV manufacturing and a rich portfolio of patented technology. Our therapeutic focus includes neuromuscular, central nervous system, cardiovascular and metabolic diseases with clinical trials underway for Pompe disease, Parkinson’s disease and congestive heart failure. Our gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive AAV capsid and promoter library.
We became a wholly owned, independently operated subsidiary of Bayer AG in late 2020 as a cornerstone of its newly formed Cell & Gene Therapy Platform. Our global headquarters are in Research Triangle Park, North Carolina, a thriving biotechnology hub, and we maintain additional research and development operations in Scotland and France and gene therapy manufacturing in Spain.
We have an opportunity for an Associate Director, Medical Writer to join the AskBio team in our Durham, North Carolina location and be part of our continued success!
About the Role
The Associate 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 Associate 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.
Responsibilities and Accountabilities
- Responsible for aligning, coordinating, and building 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).
- Analyzes 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
- Possesses and utilizes 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
- Determines resource needs, proactively identifies issues and solutions, and sets timelines and processes.
- Responsible for ensuring that statements included in the documents/deliverables are accurate and supported by appropriate data.
- Represents 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.
- Works with other Medical Writing staff, including the Head of MW to develop a messaging strategy across a program of work
- Assesses each project to proactively identify areas that will require assistance from others.
- Enhances clarity and grammatical accuracy of the writing while maintaining the voice/tone/thoughts of external authors
- Ensures scientific accuracy while editing and referencing
- Keeps 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)
- 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
- Exceptional written and oral communication skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
- A solid understanding of the clinical development process, including the documents that are required at each stage
- Expert MS Office skills with a special focus on tables, spreadsheets, presentations, graphics, and templates. Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel
- 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
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- 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
Live an AskLife™
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