Medical Writing Specialist III
Location
Work from home | India
Job description
Summarized Purpose:
Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.
Essential Functions:
- 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.
- Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
- Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
- May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
- Represents the department at project launch meetings, review meetings, and project team meetings.
Education and Experience:
- 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 5+ years).
- Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered enough for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: - Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Significant knowledge of global, regional, national and other document development guidelines - In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
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