Principal Medical Writer - Nonclinical Focus

Job summary

The Principal Medical Writer independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for organizing, analyzing, and presenting scientific and statistical information in compliance with ICH and regulatory guidelines.

Job details

Job Description: Key Purpose: The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development. The primary responsibilities of the position are organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards. The Principal Medical Writer works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams. 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; MS or PhD preferred 7+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD such as: 2.4 Nonclinical Overview 2.6 Nonclinical Summaries Pharmacology, pharmacokinetic, (ADME), or toxicology Reports 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 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 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., nonclinical section [Module 2.6]), 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 Develop 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 integrate this knowledge to deliver business successes and actively transfer this knowledge to strength 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 independently plans and prepares regulatory documents and medical communications to support product development. They are responsible for organizing, analyzing, and presenting scientific and statistical information in compliance with ICH and regulatory guidelines.

Requirements

Candidates must have a Bachelor's degree, with an MS or PhD preferred, and at least 7 years of regulatory writing experience. Proficiency in nonclinical sections of the CTD and strong understanding of the drug development lifecycle are required.

Benefits

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

Listed skills

• Microsoft Word · Preferred
• Communication · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory writing
• Nonclinical documentation
• CTD
• Pharmacology
• Pharmacokinetics
• Toxicology
• ICH guidelines
• Microsoft Word
• Document management
• Drug development lifecycle
• Data synthesis
• Submission-level documentation
• Project leadership
• Communication
• Scientific writing
• Statistical interpretation
• Document Review
• Regulatory Documents
• Document Management
• Editing
• Management
• Business Relationship Management
• Decision Making
• Document Preparations
• Document Production
• Drug Development
• Marketing
• Medical Communications
• Oncology
• Medical Writing
• New Product Development
• Coaching
• Writing
• Data Synthesis

Job areas

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

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