Clinical Regulatory Documentation Expert
vor 3 Wochen
Certara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. Our clients include over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.
Job SummaryWe are seeking a highly experienced Regulatory Writer to join our team as a Principal Regulatory Writer (PRW). As a PRW, you will be a key contributor to the development of high-quality regulatory documentation for our clients. You will lead project teams, mentor junior staff, and ensure that all regulatory documents meet the highest standards of quality and compliance.
Responsibilities- Lead the development of strategies for organizing and preparing regulatory documents for our clients.
- Manage project teams and actively participate in the development and writing of high-quality documents, including study-level and submission-level documents, pharmacovigilance documents, and other regulatory submissions.
- Serve as a liaison and subject matter expert internally and for clients, guiding and advising them on strategies and best practices for achieving approval and 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, and manage budget for all types of projects.
- 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
- Understanding of 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 (e.g. study and submission level, pharmacovigilance)
- Strong understanding of the document creation process and of the drug development lifecycle
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) 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 (clinical documents, e.g. Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE) taking 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 (e.g., pharmacovigilance documents, transparency & disclosure deliverables), taking 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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Clinical Regulatory Documentation Expert
vor 3 Wochen
Berlin, Berlin, Deutschland Certara VollzeitAbout CertaraCertara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. Our clients include over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly experienced Regulatory Writer to join our team as a...
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Berlin, Berlin, Deutschland Certara VollzeitAbout CertaraCertara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. Our clients include over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.Job SummaryWe are seeking a highly experienced Regulatory Writer to join our team as a...
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