Medical Writer - Scientific Communications

About the role

The Medical Writer - Scientific Communications will lead the development and maintenance of scientific content for assigned products, collaborating with cross-functional teams to create global medical communications resources.

Responsibilities

• Lead the development and maintenance of the scientific lexicon for assigned products.
• Partner with subject matter experts (SMEs) to develop and manage scientific content for global conferences.
• Develop and manage abstracts, posters, slide decks, manuscripts, core training and educational materials, as needed.
• Document and track agreed-upon medical materials as part of annual planning to ensure timely delivery.
• Support the development of medical education materials addressing identified educational gaps while maintaining compliance with all internal and external requirements.
• Work closely with clinical development, regulatory affairs, and other stakeholders to ensure that all medical writing deliverables meet project objectives, timelines, and internal and external requirements.
• Document review and revision of documents based on feedback from internal and external stakeholders.
• Ensure that documents are well-organized, accurate, and aligned with internal and external expectations.
• Assist in maintaining high-quality standards for all scientific documentation.
• Manage the preparation of documents within established timelines.
• Provide medical writing support across various stages of clinical development, including early-phase studies, late-stage clinical trials, and nonclinical and CMC teams as needed.
• Stay current with relevant scientific literature, regulatory guidelines, and industry trends to inform writing and ensure documents reflect the latest standards and best practices.

Qualifications

• A minimum of a Bachelor’s degree in a life sciences discipline (e.g., Pharmacology, Pharmaceutical Sciences, Biology, or related field).
• A Master’s or Ph.D. is preferred.
• At least 5-8 years of experience in medical writing, with hands-on experience in authoring clinical documents for regulatory submissions.
• Experience in oncology therapeutic area is highly preferred.
• Writing Skills: Excellent written and verbal communication skills with the ability to convey complex scientific information clearly and concisely for a variety of audiences.
• Tools: Experienced with standardized writing templates (e.g. StartingPoint or alike) and submission management platforms (e.g. Veeva Vault).
• Attention to Detail: Exceptional attention to detail and a commitment to producing accurate, high-quality documents.
• Collaboration: Ability to collaborate effectively with cross-functional teams, including clinical, regulatory, and other departments, to produce high-quality documentation.
• Scientific Knowledge: In-depth understanding of clinical research and scientific concepts to ensure that clinical documents are scientifically accurate and reflect the latest research findings.
• Time Management: Strong organizational and time management skills, with the ability to manage multiple projects and meet deadlines in a fast-paced environment.
• Problem-Solving: Ability to proactively identify and address challenges related to document quality, clarity, and regulatory requirements.