Job Description

Position Overview:We are seeking a highly qualified and experienced Senior Medical Writer to join our team. The ideal candidate will have over 10 years of experience in medical writing, with a proven track record of producing high-quality, scientifically accurate, and regulatory-compliant documents. This role offers the opportunity to work on a variety of projects, collaborate with cross-functional teams, and contribute to the success of our clients and products.

Key Responsibilities

Lead the development of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submission documents.
Ensure all documents are scientifically accurate, clear, and adhere to regulatory guidelines and company standards.
Collaborate with cross-functional teams, including clinical research, regulatory affairs, biostatistics, and project management, to gather and interpret complex scientific data.
Provide strategic input and expertise on clinical development plans, regulatory strategies, and publication plans.
Mentor and guide junior medical writers, providing training and feedback to foster professional growth and development.
Stay current with industry trends, regulatory requirements, and best practices in medical writing.

Qualifications

A minimum of 8-10 years of experience in medical writing within the pharmaceutical, biotechnology, or medical communications industries.
Advanced degree in a life science discipline (PhD, PharmD, MD) preferred.
Extensive knowledge of clinical development and regulatory processes.
Exceptional writing, editing, and communication skills, with a keen attention to detail.
Strong organizational skills and the ability to manage multiple projects and deadlines simultaneously.
Proficiency in Microsoft Office Suite and familiarity with document management systems.
Ability to work independently and as part of a collaborative team.

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Senior Medical Writer