The Medical Writer is responsible for providing high-quality regulatory medical writing for internal and external clients. The role includes offering technical consultation, strategic advice, and delivering quality products within agreed timelines. The Medical Writer collaborates with various stakeholders to ensure effective communication and operational excellence.
Essential Duties and Responsibilities:
- Independently research, write, and edit peri-/post-approval clinical study reports, study protocols, informed consent forms, and other regulatory documents.
- Support the development of complex clinical or scientific documents, such as Investigator’s Brochures (IBs), and sections of Investigational New Drug applications (INDs), New Drug Applications (NDAs), and Common Technical Documents (CTDs).
- Manage all aspects of project planning, organizing, and execution, including developing project timelines, standards, budgets, forecasts, and contract modifications.
- Liaise with other functional units as necessary (e.g., project management, clinical, QA, data management, biostatistics, regulatory, and other practice areas).
- Identify and escalate out-of-scope project activities promptly and propose solutions.
- Interact with internal and external personnel on significant matters, often requiring coordination between functional areas.
- Represent the department as a primary contact on projects, including project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations.
- Establish and develop client relationships and lead interactions with clients independently.
- Assist with business development and development of budgets and proposals.
Education, Professional Skills & Experience:
- Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
- Previous experience as a medical writer (2-5 years) or equivalent combination of education, training, and experience.
- Experience in the pharmaceutical/CRO industry is preferred.
- Additional qualifications in medical writing (AMWA; EMWA; BELS; RAC) are advantageous.
- Significant knowledge of global, regional, national, and other document development guidelines.
- In-depth knowledge in a specialty area such as therapeutic, regulatory submissions, healthcare communications, etc.
- Excellent computer skills and familiarity with client templates; good knowledge of document management systems and relevant applications (e.g., Excel, Outlook).
Personal Skills & Competencies:
- Excellent written English: ability to communicate and document information effectively in written English, producing well-organized, error-free documents.
- Aptitude to work with, manipulate, and format numerical data to provide evidence, information, and insights.
- Ability to analyze complex issues, identify information gaps, and generate effective solutions.
- Skill in creating and managing effective project plans, monitoring progress, and delivering results.
- Sound professional judgment in analyzing, responding to, and resolving inquiries and issues.
- Ability to facilitate conflict resolution among team members and clients, gaining agreement on appropriate actions, and ensuring successful outcomes.
