Principal Regulatory Writer- Clinical Focus

Certara (CERT) is the largest and most comprehensive provider of strategic drug development, modeling & simulation and regulatory science services. We partner with biopharmaceutical businesses to optimise drug development decisions and accelerate the drug development process.

At Certara, you will play an important role helping our clients develop new therapies and target unmet medical needs, expand the benefits of existing therapies to other populations, communicate scientific information in the language of regulatory success, balance risk profiles, differentiate drugs from a competitive perspective, and unlock millions in R&D savings. Ultimately, you’ll be helping more critical drug products get to more patients,

Certara has global team ~1000 employees with more than 300 PhD, PharmD, and MD scientists and regulatory writers, working on key drug development projects for biopharmaceutical companies.

We value each and every one of our employees and demonstrate that by offering our employees:

• Opportunity for career advancement that align to your professional goals.
• Collaborative work environment where you will continuously learn and work towards a common goal.
• Competitive benefits and compensation packages that reward your strong performance.
• Genuinely impactful work that will make a difference to the lives of people all over the world
• Flexibility – the option to work remotely or in one of our global office locations.

We Look For

• A high degree of professionalism: Transparency, authenticity, collaboration, respect and accountability.
• A “Growth Mindset”
• A Continuous Learner
• The ability to adapt – we’re an ever growing, evolving organisation with ambitious plans. With that comes change and we look for people who can embrace, and contribute to, that journey.

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

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)
• 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 (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 clinical, non-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

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.

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