AD/Director, Medical Writing
Our client, a biopharmaceutical company developing and delivering novel therapies for the management of CNS disorders, is currently seeking an Associate Director/Director, Medical Writing to join their clinical development team. This person will be responsible for leading medical writing activities and drafting, editing, and submitting high-quality documents including protocols, clinical study reports, and regulatory submissions.
Responsibilities:
- Interpret complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications, and other documents in support of Clinical Development programs
- Attends strategic meetings as applicable
- Closely collaborates with, and apply applies strategic direction from, project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
- Develops documents for assigned programs in compliance with company standard operating procedures (SOPs). This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
- Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
- Oversees outsourced medical writings projects and the associated vendor(s), as applicable
Qualifications:
- Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
- Previous experience with preparation and QC of various document types including core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
- Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
- Expertise in use of online and other data sources for literature searches and information
- General knowledge of the drug development and approval processes and GXP principles
- Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
- Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
- Flexible and able to adapt to changing deadlines and priorities
- Excellent written, verbal, and interpersonal communication skills
If you are interested in this position, please send your resume to ecallender@daleyaa.com
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