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Certara · 2 days ago

R&A - Associate Principal Regulatory Writer (APRW) - Clinical Focus

United States

Full-time

Remote

Senior Level, Lead/Staff

5+ years exp

Certara is the largest and most comprehensive provider of strategic drug development and regulatory science services. The Associate Principal Regulatory Writer (APRW) will lead the development of regulatory documents and manage project teams while ensuring high-quality submissions for clients in the biopharmaceutical industry.

BiotechnologyHealth CarePharmaceuticalSoftware

Growth Opportunities

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, and 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, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result

Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work

Manage budget for a low complexity project, including all contributors (writers, editors)

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

Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

Qualification

Regulatory writingClinical Study ReportsClinical Study ProtocolsMicrosoft WordDocument managementData synthesisCoaching othersProblem resolutionTherapy area expertiseCommunication best practices

Required

Bachelor's degree; MS or PhD preferred

5-8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as: 2.5 Clinical Overview, 2.7 Clinical Summaries, Clinical Study Reports, Clinical Study Protocols, Briefing Documents

Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance

Experience in the development of submission-level documents (does not require functioning as a document lead)

Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques

Strong understanding of the document creation process and of the drug development lifecycle

Able to synthesize data across multiple data sources and documents to create summary reports

Expertise to provide subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization

Ability to own submission-level sections (e.g., clinical section [Module 2.7]), 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

Develops professional relationships with clients as a way to further the business relationship and maintain current industry knowledge

Ability to identify and institutionalize work practices that are most effective in order to ensure consistency in performance

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 integrates this knowledge to deliver business successes and actively transfer this knowledge to strength the skill base across the organization