Principal Medical Writer - CMC Focus

Job summary

The Principal Medical Writer serves as a project leader and primary author for complex regulatory documentation, specifically focusing on CMC submissions. They are responsible for mentoring team members and ensuring high-quality, compliant document finalization across various client engagements.

Job details

Job Description: Job Overview: Regulatory Writers prepare high‑quality documentation for regulatory submissions to help streamline the regulatory documentation process for our clients. The Principal Medical Writer (PMW) is a major contributor to document authorship for a variety of documents across different service lines. The PMW will be the project leader and authoring contributor for all types of client engagements, while mentoring others in the knowledge of authoring regulatory documents. Make an Impact at Veristat! Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide. 105+ approved therapies for marketing applications prepared by Veristat 480+ oncology projects in the past 5 years 350+ rare disease projects delivered in the past 5 years Flexible, inclusive culture — 70% remote workforce, 66% women-led teams Learn more about our core values here! What we offer: The estimated hiring range for this role is $132K to $151K plus applicable bonus. This hiring range is specific to the US and will vary for other regions based upon local market data. Final salary is ultimately decided upon taking into account a wide range of factors, including but not limited to: skills and experience, licensure and certifications, education, specific location and dynamic market data. Benefits vary by location and may include: Remote working Flexible time off Paid holidays Medical insurance Tuition reimbursement Retirement plans What we look for: Education, Experience, Training, and Knowledge: Bachelor’s degree or higher, scientific discipline strongly preferred 7+ 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 (e.g., 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 and 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 (e.g., 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 in ensuring 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 Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process. Veristat is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

What you’ll do

The Principal Medical Writer serves as a project leader and primary author for complex regulatory documentation, specifically focusing on CMC submissions. They are responsible for mentoring team members and ensuring high-quality, compliant document finalization across various client engagements.

Requirements

Candidates must possess a bachelor's degree or higher in a scientific discipline and at least 7 years of regulatory writing experience, specifically with CMC documentation. Proficiency in authoring submission-level documents and a strong understanding of global health authority requirements are essential.

Benefits

• Medical insurance
• Tuition reimbursement
• Retirement plans
• Flexible time off
• Paid holidays

Listed skills

• Microsoft Word · Preferred
• Communication · Preferred
• Time management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory writing
• CMC documentation
• Submission-level documents
• Project leadership
• Module 3 authoring
• Drug development lifecycle
• Data synthesis
• Microsoft Word
• Regulatory guidelines
• Communication
• Time management
• Quality document preparation
• Mentoring
• Regulatory pathways
• Technical writing
• Document Review
• Regulatory Documents
• Document Management
• Small Molecules
• Organizational Skills
• Chemistry
• Editing
• Biopharmaceuticals
• Business Relationship Management
• Cell Therapy
• Decision Making
• Document Preparations
• Drug Development
• Global Health
• Marketing
• Oncology
• Medical Writing
• Mentorship
• Coaching
• Time Management
• Writing
• Data Synthesis

Job areas

• Healthcare
• Science & Research
• Consulting
• Management & Leadership
• Principal
• Medical Writer
• Authors and Related Writers
• Technical Writers

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