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Clinical Regulatory Writing Associate Principal
3 months ago
Position Overview
About Certara
Certara enhances the development of pharmaceuticals through its proprietary biosimulation software, technology, and services, aiming to revolutionize the conventional processes of drug discovery and development. Our clientele includes over 2,000 biopharmaceutical companies, academic institutions, and regulatory bodies across 62 nations.
As a Regulatory Writer, your role will involve crafting high-quality documentation for regulatory submissions, facilitating a smoother regulatory approval journey for our clients. The Associate Principal Regulatory Writer (APRW) will play a pivotal role in authoring documents across various clinical areas. The APRW will lead smaller projects while also contributing to larger, more intricate assignments as part of a collaborative delivery team.
Key Responsibilities- Collaborate closely with clients and internal teams to devise strategies for organizing and preparing regulatory documents.
- Lead project teams and actively engage in the development and writing of high-quality documents, including study-level and submission-level materials.
- Draft documents in accordance with client specifications, templates, style guides, and other relevant documentation.
- Ensure compliance with regulatory authority guidelines and requirements in document preparation.
- Serve as a trusted advisor to clients, fostering strong relationships through consistent and reliable communication; articulate ideas and strategies to achieve successful outcomes.
- Employ blameless problem-solving techniques, considering diverse perspectives to resolve issues and mitigate negative impacts on work.
- Oversee budgets for low-complexity projects, managing all contributors including writers and editors.
- Guide documents through the review process, lead comment resolution meetings, and drive project teams toward consensus.
- Maintain proactive and effective communication with both clients and internal teams.
- Facilitate project-related meetings and teleconferences.
- Provide mentorship to junior staff on both study-level and submission-level documents, ensuring adherence to company standard operating procedures (SOPs) and training requirements.
- Bachelor's degree.
- 8+ years of experience in regulatory writing, specifically with clinical documentation.
- Comprehensive understanding of regulatory requirements across various development phases and pathways.
- Familiarity with global health authority standards.
- Experience in creating submission-level documents.
- Intermediate proficiency in Microsoft Word, including editing tools, table creation, and figure insertion.
- Strong grasp of the document creation process and the drug development lifecycle.
- Adept at synthesizing data from multiple sources to produce summary reports.
- Expertise in providing subject matter guidance for quality document preparation, review, accurate comment resolution, and finalization.
- Ability to take ownership of submission-level sections (clinical documents such as Clinical Study Reports, Protocols, Investigator Brochures, ISS, and ISE), ensuring clarity of purpose and leading teams toward common goals within timelines and budgets on complex projects.
- Demonstrated understanding of communication best practices, coaching others on the implications of decision-making.
- Ability to cultivate professional relationships with clients to enhance business relationships and maintain industry knowledge.
- Capability to identify and institutionalize effective work practices to ensure consistent performance.
- Proficient in resolving issues, particularly in sensitive or high-pressure situations.
- Possesses extensive experience and technical expertise across multiple therapeutic areas, integrating this knowledge to achieve business success and enhance organizational skill sets.
Certara is committed to making employment-related decisions based on merit, considering qualifications, skills, achievements, and performance. We ensure that all applicants and employees are treated fairly, without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or any other characteristic protected by law.
