Principal Regulatory Writer

**Job 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.

**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)
- 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 (e.g. CMC section) 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

**Education, Experience, Training, and Knowledge**:

- Bachelor’s degree (minimum)
- 10+ years of regulatory writing experience with nonclinical, clinical, CMC or pharmacovigilance 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 (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 (e.g., nonclinical section [Module 2.6]), 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

**About Certara**

Certara is a growing company that provides a novel and exciting place to work. Our purpose is to assist in accelerating the development of meaningful medicines that make an impact on our society and the people that need them most. Innovation and creativity are highly valued, and everyone is given the opportunity for training and continuous development. Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies. The well-being of our employees is a priority at Certara, and that is why we support the most important aspects of their lives:

- Financial - competitive pay, incentives, retirement plans, income security programs
- Health and Wellness - comprehensive benefit package, wellness programs, healthy lifestyle office environments
- Work/Life - unlimited paid time off and an employee assistance program
- Growth & Development - perform