Medical Writer
The Steely Group
Hybrid, Chicago, IL
JOB DETAILS
LOCATION
Hybrid, Chicago, IL
POSTED
30+ days ago
Responsibilities:
- Develop and author a broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.).
- Ensure accuracy, clarity, consistency, and compliance with internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs.
- Collaborate cross-functionally with colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents.
- Translate highly technical and statistical information into clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required.
- Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications.
- Maintain document quality control through proofreading, editing, and adherence to templates, style guides, and version control procedures.
- Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents.
- Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
- Ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines.
- Performs literature searches and reviews as necessary to obtain background information and provide literature references.
- Provide input on processes, templates, and other business needs within the medical writing function.
- Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents.
- Serve as a point person for medical writing guidance and document-related problem resolution.
- Bachelors degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred.
- Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3).
- Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines.
- Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools.
- Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving
- Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel.
- This is a hybrid position located in client's Chicago office and requires three days per week on-site. On-site requirement may change at managements discretion.
About the Company
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