Regulatory Writer

vor 1 Monat

Berlin, Berlin, Deutschland Certara Vollzeit
Overview

Certara is a leading provider of biosimulation software, technology, and services that accelerate the development of medicines. We work with over 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries.

Job Summary

We are seeking a highly experienced Principal Regulatory Writer to join our team. As a key member of our regulatory writing team, you will be responsible for preparing high-quality documentation for regulatory submissions, working closely with clients and internal teams to develop strategies for organizing and preparing regulatory documents.

Responsibilities
  • Lead the development of regulatory documents, including study-level and submission-level documents, pharmacovigilance documents, and other regulatory submissions.
  • Collaborate with clients and internal teams to develop strategies for organizing and preparing regulatory documents.
  • Author documents per client specifications, templates, style guides, and other guidance documents.
  • Author documents per regulatory authority guidelines and requirements.
  • Act 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.
  • Manage budget for all types of projects, 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.
Qualifications
  • 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
Skills & Abilities
  • 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
EEO

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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