Associate Medical Writer

hace 6 días

Bogota, Colombia MSD A tiempo completo

The Medical Writing Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio. The Assistant Narrative Medical Writer is responsible for the development of medical writing deliverables for a limited set of documents within a single therapeutic area under the supervision of management and Principal Medical Writer Safety Lead. The MW supports the clinical development pipeline through scientific contribution of clinical documents related to safety. The MW delivers quality English language documents in compliance with internal conventions and industry standards in a timely and efficient manner following the department and company processes and tools. The Associate Medical Writer works with guidance and oversight to develop - Prepares selected components of regulatory clinical documentation - Develops knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects - Participates, with supervision, on document-specific teams - Develops competence in writing, editing, and reviewing clinical study reports, patient narratives, investigator brochures, and other clinical regulatory documents per company and other guidelines- Acquires a thorough understanding of medical writing responsibilities, including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings - Identifies challenges associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members - May participate in initiatives to improve medical writing processes and standards Qualifications, Skills & Experience - Degree in a life science, preferably related to pharmacy or medicine - Bachelor’s degree with 2+ years; MS with 1+ year; or doctoral-level degree (e.g., PhD, MD, DVM, DO, PharmD) with

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