Regulatory Writer
Vor 2 Tagen
Certara is 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 for our clients.
About CertaraCertara accelerates medicines using proprietary biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
Responsibilities- Lead the development of strategies for organizing and preparing regulatory documents
- Lead project teams and actively participate in the development and writing of high-quality documents
- Serve as a liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval/agreement from regulatory authorities
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as a client advisor and proactive consultant to collaborate and anticipate the needs of the client based on the relationship and knowledge while looking for new business opportunities
- Take ownership of entire deliverables, including multiple writers
- Manage budgets for all types of projects and liaise with finance and mentor others in fiscal responsibility and outcomes at the project level
- Usher documents through the review process, conduct comment resolutions meetings, and successfully lead a project team to consensus
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- Lead project-related meetings and teleconferences and coach others in same
- Provide coaching to junior staff for all documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements
- Bachelor's degree (minimum)
- 10+ years of regulatory writing experience with clinical-related documentation
- Understands regulatory requirements for different phases of development and different regulatory pathways
- Knowledge of global health authority requirements
- Collective experience writing and leading a range of documents in their entirety
- Strong understanding of the document creation process and of the drug development lifecycle
- 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 all crisis communications, managing risks, and realizing business opportunities
- Ability to communicate difficult and complex ideas clearly and effectively to all stakeholders
- Ability to lead submission-level sections and take responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Ability to lead sub-teams for deliverables and take responsibility for clarity of purpose, leading others toward the common goal within timeline and budget on complex projects
- Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
- Ability to identify potential problems, promptly tackling those problems, particularly in sensitive or high-pressure situations
- Possesses broad experience and technical expertise across more than one therapy area and integrate this knowledge to deliver business successes and actively transfer this knowledge to strengthen the skill base across the organization
Certara bases all employment-related decisions on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees 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 other characteristic protected by law.
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