Principal Medical Writer (Regulatory MW)
- Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.
- Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices.
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Acts with intensity
- Strong project management skills
- Excellent interpersonal skills including problem solving and negotiation
- Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Experience in managing and directing complex Regulatory medical writing projects required
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous.
- Significant knowledge of global, regional, national and other document development guidelines
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc
- Strong project management skills
- Excellent interpersonal skills including problem solving and decision-making
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency
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