Director, Medical Writing Job Description Template
Our company is looking for a Director, Medical Writing to join our team.
Responsibilities:
- Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data;
- Other responsibilities may be assigned as needed;
- Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies;
- Work with clinical and regulatory teams to be sure that all deliverables are in accordance with regulations, standards, and guidelines;
- Lead document review and comment resolution meetings with cross-functional teams;
- Partner with the regulatory team to prepare other documents, as needed, for submission to Health Authorities;
- Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports;
- Build and maintain a positive working relationship with key stakeholders, team members and vendors;
- Ensure continuous awareness of the medical writing activities, plans, scope(s) of work and ways of working across the organization;
- Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents;
- Work with third parties including academic partners, key opinion leaders, and contractors during development of technical documents;
- Execute literature reviews and competitive landscape research contributing to development strategy;
- Interact with internal stakeholders and external service providers to ensure the timely development, review, and publication of documents;
- Consult cross-functionally to develop communication goals, objectives and plan to best communicate scientific messages;
- Create tables, charts, figures, and other visual display elements for presenting clinical data.
Requirements:
- PhD (or equivalent degree) and 7+ years of relevant work experience;
- Strong leadership and influencing skills;
- Attention to detail;
- Experience managing direct and indirect reports, including medical writing contractors;
- Experience authoring clinical regulatory documents;
- Leadership role in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA);
- Ability to plan, manage, and optimize resources;
- Experience in managing medical writers preferred;
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally;
- More than 10 years of Medical Writing experience with evidence of increasing responsibility/technical development;
- Demonstrated abilities in collaboration with others and independent thought;
- Careful attention to detail and accuracy;
- Ability to assess workload and suggest prioritization to senior staff;
- B.S. or equivalent degree in a scientific area. Advanced degree (MS or PhD) preferred;
- Knowledge of regulations relevant to medical writing within oncology.