Medical Writing Operations Specialist II

Role Summary

Medical Writing Operations Specialist II

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

• BS/BA degree in a related discipline; or,
• MS/MA degree in a related discipline; or,
• Equivalent combination of education and experience.

Additional Requirements

• 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.
• Familiarity with therapeutic area of oncology is preferred.