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Responsibilities
- Lead development of clinical study protocols and amendments.
- Develop timelines for clinical documents with the team and CROs.
- Co-author protocols and IBs with cross-functional SMEs.
- Review or contribute to supporting study documents as needed.
- Lead the development of CSRs and data summaries for submissions.
- Co-author robust CSR shells in preparation for database locks.
- Prepare written summaries for submission to regulatory agencies.
- Lead data integrity reviews of CSRs and data summaries.
- Respond to information requests from regulators efficiently.
- Author content for meetings with regulators or key opinion leaders.
- Identify risks and contribute to risk mitigation planning.
- Contribute to maintenance of document templates and training materials.
- Advocate for industry best practices across cross-functional teams.
Requirements
- Bachelor’s degree in a scientific discipline, advanced degree preferred.
- Minimum of 6+ years of experience in pharmaceutical medical writing.
- Proven track record managing clinical study protocols and reports.
- Strong knowledge of global pharmaceutical regulations and guidelines.
- Knowledge of drug-drug and biologic-biologic combination products is a plus.
- Excellent leadership, collaboration, communication, and interpersonal skills.
- Strong problem-solving and critical thinking abilities.
- Ability to meet deadlines and adapt to changing priorities.
- Proficiency in word processing software and document management systems.
Benefits
- Opportunity to work in a fast-paced, dynamic environment.
- Market competitive compensation and benefits package.
- Unlimited PTO and two company-wide shutdowns each year.
- Commitment to provide professional development opportunities.
- Remote working environment with frequent in-person meetings.
