Summary of Position:
The Medical Writing Projects Director will be responsible for document development strategies and managing Medical Writing activities and timelines for clinical and regulatory/health authority drug marketing applications, including US (Investigational New Drug, New Drug Applications, Biologics Licensing Applications) and ex‑US (Clinical Trial Applications, Marketing Authorisation Applications) submissions. This position requires a highly motivated professional with experience in submitting successful drug marketing applications. Key success factors include exceptional leadership skills and scientific writing skills; integrative thinking with a team-centric collaborative mindset; ability to work independently and influence decision-makers; exceptional communication skills; work well under pressure in a fast-paced environment with tight deadlines; and the ability to supervise multiple Medical Writing Projects, contractors, vendors, and budgets.
Position Responsibilities:
- Create, supervise, and direct complicated document submission plans and teams for marketing applications
- Collaborate with cross-functional partners to drive development, review, and finalization timelines for submission documents with a sense of urgency to meeting aggressive corporate goals
- Lead and manage senior-level subject matter experts in the development of complex summary documents (summary and integrated summary documents) for submissions
- Liaise with senior management to provide transparency on submission activities
- Manage internal and external resources (contractors, consultants, and vendors) to complete documents for drug applications and submissions
- Partner with Regulatory and Regulatory Operations to ensure successful submissions
- Represent Medical Writing on cross-functional teams and workstreams
- Develop templates, style guidelines, and SOPs related to the Medical Writing function
- Help build the Medical Writing group to adequately meet the document development needs of SRRK
Candidate Requirements:
- Advanced degree in a relevant scientific field preferred; Bachelor of Science in a relevant scientific field required
- 10+ years of experience in Medical Writing within the pharmaceutical/biotech industry, with at least 5+ years at a sponsor company; experience with devices is a plus
- 5+ years of experience and a proven track record of successful drug application submissions to US (FDA) and ex-US (EMA, MHRA, PMDA) health authorities
- Extremely strong leadership skills
- Expert knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory science, and medical terminology
- Expert knowledge of requirements for the preparation of documents for drug marketing applications and for annual maintenance of clinical development programs (Investigator’s Brochures, Annual Reports, Clinical Study Reports)
- Ability to work independently in a fast-paced, small biotech corporate environment
- Ability to be creative and innovative
- Common sense