Principal Regulatory Writer- Clinical Focus Job in Certara EMEA

  • Full Time
  • EMEA

Website Certara

This Job Listing is about Certara in EMEA 2022

About the job


Certara is hiring an Principal Regulatory Writer to join our Synchrogenix Regulatory Services division!

Company Overview

Certara optimizes R&D productivity, commercial value, and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. In fact, since 2014, our customers have received over 90% of new drug and biologic approvals by the FDA.

As Certara’s regulatory science division, Synchrogenix, a Certara company, assures and accelerates regulatory success through a unique combination of customized regulatory strategy, document authoring, medical communications and publications, and operations solutions. Synchrogenix’s proven record of success is built on an unrivaled commitment to quality and compliance combined with the use of advanced technologies to enhance speed and efficiency.

Position Overview

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory documentation process for our clients. The Principal Regulatory Writer (PRW) is a major contributor to document authorship for a variety of documents across different service lines. The PRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.

What We Offer

  • Flexibility: The option to work remotely or in one of our global office locations
  • Recognition: Synchrogenix recognizes and celebrates the extensive experience and expertise our writers bring to regulatory submissions and product approvals.
  • Cutting edge technology: Upskill with advanced technologies that enhance speed and efficiency
  • Collaborative work environment: A team-based, collaborative approach to regulatory writing provides our writers with the support they need to deliver the highest quality work.
  • Comprehensive benefits: Competitive compensation, incentives, full benefits, and flexible paid time off (PTO)

Responsibilities

  • Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
  • Lead a project team, actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
  • Serve as 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 for all document types that Synchrogenix writes
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Author documents per regulatory authority guidelines and requirements
  • Act as 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 deliverable that include multiple writers
  • 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 (CRMs), 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

Requirements For The Role

  • Bachelor’s degree, minimum; advanced degree preferred
  • 10+ years of regulatory writing experience with clinical-related documentation
  • Deep understanding of global regulatory requirements for different phases of drug development and different regulatory pathways
  • Experience in the development of clinical and submission-level documents
  • Mastery of Microsoft Word skills (editing tools, creating and modifying tables, and inserting figures) and document management techniques
  • Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
  • Ability to resolve problems that arise, 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

Locations: Remote-based in Germany, France, Netherlands and UK

Certara bases all employment-related decision 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.

Company: Certara

Vacancy Type: Full-time · Associate 

Job Location: EMEA

Application Deadline: N/A

Apply Here

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