Associate Principal Regulatory Writer - CMC

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

Job Overview:
Regulatory Writers prepare high-quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of documents across different service lines. The APRW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents.
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 the development and writing of high-quality documents (study-level and submission-level documents and 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 result
Practice problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
Manage hours/budgets for their projects, including all contributors (writers and editors)
Usher documents through the review process, conduct comment resolution 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
Review documents and provide coaching to junior staff for study-level and submission-level documents
Ensure all assigned staff comply with client standard operating procedures and training requirements, as required
Education, Experience, Training, and Knowledge:
Bachelor's degree or higher, scientific discipline strongly preferred
5 to 8+ years of regulatory writing experience with Chemistry, Manufacturing, and Controls documentation
Experience in areas such as vaccines, gene/cell therapy, biologics, small molecule, manufacturing, analytical, or stability
Experience with submissions such as NDAs, INDs, BLAs, or IMPDs
Experience authoring and leading Modules 3 (eg, Modules 3.2.S and 3.2.P) and Module 2.3
Understanding of regulatory authority guidelines and requirements and to anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
Ability to lead a project team
Understand regulatory requirements for different phases of development and different regulatory pathways
Knowledge of global health authority requirements
Experience as a document lead in the development of submission-level documents
Skills & Abilities:
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
Ability 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 documents (eg, Module 3), taking responsibility for clarity of purpose, leading others toward the common goal within the timeline and budget on complex projects
Demonstrate an understanding of communication best practices, coaching others on communication implications of decision making
Demonstrate solid time management and other organizational skills
Ability to develop professional relationships with clients as to further the business relationship and maintain current industry knowledge
Ability to identify and institutionalize work practices that are most effective to ensure consistency in performance
Ability to resolve problems that arise, particularly in sensitive or high-pressure situations
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... For full info follow application link.

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.        

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Job Posting: 990782

Posted On: Jun 21, 2022

Updated On: Jul 21, 2022