Medical Writing Operations Specialist II

Role Summary

This role will perform quality review of regulatory documents to ensure content accuracy and consistency. Document scope includes but is not limited to clinical and nonclinical CTD Module 2 summaries, briefing documents, protocols, investigator brochures, clinical study reports (CSRs), and other types of cross-functional documents and reports.

Responsibilities

• Ensure compliance with company and industry standards as well as regulatory expectations, supporting the drug development pipeline through high-quality regulatory submissions that contribute to successful product approvals.
• Ensure that data and information in complex documents are accurate, consistent with source documents, internally consistent, and meet company standards of style and quality.
• Edit regulatory documents according to company style guide and American Medical Association (AMA) style.
• Monitor timelines for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
• Contribute to the development of process improvements, authoring or editing tools, and the development or revision of internal policies, procedures, and job aids.
• Participate actively in group meetings and in cross-departmental project teams as needed.
• Other duties as assigned.

Qualifications

• BS/BA degree in a related discipline and a minimum of 5 years of related experience; or
• MS/MA degree in a related discipline and a minimum of 3 years of related experience; or
• Equivalent combination of education and experience.
• BELS certification is a plus.
• Experience in Biotech/Pharmaceutical industry required.
• 3 to 5 years of quality assurance, clinical development, or laboratory experience; or equivalent experience in the pharmaceutical industry.
• Strong working knowledge of drug development process, regulatory guidelines, industry standards, and best practices.
• Experience reviewing documents for regulatory submissions (e.g., INDs, NDAs, BLAs, sNDAs, TIIVs, CTDs, clinical protocols, CSRs).
• Knowledge of AMA style and medical terminology.
• Familiar with VeevaRIM or other document management system and document authoring technologies.
• Familiarity with therapeutic area of oncology is preferred.

Skills

• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates.
• Manages time to complete tasks and achieve results within established timelines. Takes pride in delivering high quality work.
• Strong attention to detail and comfortable working in a fast-paced environment.
• Ability to work with cross-functional teams in a matrixed team environment, collaborate with a wide variety of team members, and relate effectively to people at all levels of the organization.
• Team player who demonstrates initiative and applies good judgement.
• Embraces change and has a flexible and innovative mindset.

Education

• Not specified beyond qualifications above.