Regulatory Writer
vor 2 Wochen
Certara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. With a global presence, we serve over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies.
Job SummaryWe are seeking a highly skilled Principal Regulatory Writer (PRW) to join our team. As a PRW, you will be responsible for leading the development of high-quality regulatory documents, mentoring junior staff, and collaborating with clients and internal teams to achieve regulatory approval.
Key Responsibilities- Develop strategies for organizing and preparing regulatory documents in collaboration with clients and internal teams.
- Lead project teams and participate in the development and writing of high-quality documents, including study-level and submission-level documents, pharmacovigilance documents.
- Serve as a liaison and subject matter expert, guiding clients and internal teams on strategies and best practices for achieving regulatory approval.
- Author documents per client specifications, templates, style guides, and regulatory authority guidelines.
- Manage budgets for projects, liaise with finance, and mentor others in fiscal responsibility.
- Usher documents through the review process, conduct comment resolutions meetings, and lead project teams to consensus.
- Maintain collaborative communication with clients and internal teams.
- Bachelor's degree (minimum).
- 10+ years of regulatory writing experience with clinical-related documentation.
- Understanding of regulatory requirements for different phases of development and regulatory pathways.
- Knowledge of global health authority requirements.
- Collective experience writing and leading a range of documents in their entirety.
- Intermediate proficiency with Microsoft Word skills and document management techniques.
- Able to synthesize data across multiple data sources and documents to create summary reports.
- Practice blameless problem-solving, effectively managing crisis communications, managing risks, and realizing business opportunities.
- Ability to communicate complex ideas clearly and effectively to all stakeholders.
Certara is an equal opportunities employer and welcomes applications from diverse candidates. We are committed to creating an inclusive work environment that values diversity, equity, and inclusion.
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