Medical Writer in Costello Medical's Medical Communications team specializing in scientific publications and communication of clinical trial data. Collaborating with clients to deliver high - quality scientific materials.
About the role
- Medical Writer creating and reviewing regulatory and public-facing documents. Supporting clinical and regulatory strategies with an emphasis on compliance and health literacy principles.
Responsibilities
- The review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents in support of the company portfolio.
- Acquires and applies knowledge and understanding of medical writing responsibilities, including design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy).
- Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements.
- Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
- Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval.
- Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools).
Requirements
- Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.
- Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics.
- Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities.
- Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams.
- Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders.
- Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days
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