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.