Medical Writer - Scientific Communications
Objective
Reporting to the Head of Medical/Regulatory Writing, the Medical Writer - Scientific Communications will be responsible for the development and oversee vendors, as needed, for creation of high-quality scientific content. This role will collaborate with cross-functional teams for the development of global medical communications resources for use both internally and externally. Essential Functions
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Medical Writing:
- Lead the development and maintenance of the scientific lexicon for assigned products.
- Lead the development and maintenance of scientific platforms for assigned products.
- Partner with subject matter experts (SMEs) to develop and manage scientific content for global conferences.
- Lead the development of 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 that address identified educational gaps while maintaining compliance with all internal and external requirements.
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Cross-Functional Collaboration: Work closely with clinical development, regulatory affairs, and other stakeholders (e.g., nonclinical, CMC etc) to ensure that all medical writing deliverables meet project objectives, timelines, and internal and external requirements.
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Document Review and Revision: Participate in the 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.
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Quality Assurance: Assist in maintaining high-quality standards for all scientific documentation. Ensure consistency, accuracy, and scientific rigor in all written materials.
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Project Support: 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. Manage the preparation of documents within established timelines.
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Knowledge Management: 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
***** For this position, we are prioritizing applicants that have worked directly for a sponsor or CRO. We are not considering consultants to meet our needs at this time ****
- Experience of 5-8 years in medical writing within the pharmaceutical, biotechnology, or clinical research industry. Experience in oncology therapeutic area is highly preferred.
- Strong scientific communications expertise with demonstrated experience developing impactful scientific materials
- Ability to manage multiple writing projects simultaneously and meet deadlines while maintaining high-quality standards.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Experience
- 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 inauthoring clinical documents for regulatory submissions. Experience in oncology therapeutic area is highly preferred.
Knowledge / Skill / Ability
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Writing Skills: Excellent written and verbal communication skills with the ability to convey complex scientific information clearly and concisely for a variety of audiences.
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Tools: Experienced with standardized writing templates (e.g. StartingPoint or alike) and submission management platforms (e.g. Veeva Vault).
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