Principal Medical Writer - Clinical Focus

Veristat; Northern (KY); Hybrid; USD 132,000 - 151,000; Full time

Job summary

Veristat is seeking a Principal Medical Writer with a clinical focus to lead authoring and mentoring across regulatory documents for diverse client engagements. This fully remote role supports US, Canada, and international sites, and centers on delivering high-quality study reports, protocols, and safety documents on tight timelines.

You will drive submission-level sections, oversee project teams, and ensure clarity of purpose while coaching others in writing best practices.

Qualifications

• Bachelor’s degree (minimum)
• 7+ years of regulatory writing experience with clinical-related documentation
• Understands regulatory requirements for different phases of development and different regulatory pathways
• Knowledge of global health authority requirements
• Experience leading a range of documents for submission (e.g., CSR, Protocols, IB, ISS/ISE)

Responsibilities

• Lead and author regulatory documents across client engagements
• Manage submission-level sections (clinical documents, CSR, Protocols, IIB, ISS/ISE)
• Mentor others in regulatory writing and authoring best practices
• Coordinate cross-functional teams to ensure timely delivery

Skills

Regulatory writing

Leadership

Communication

Cross-functional collaboration

Data synthesis

Education

Bachelor's degree

7+ years regulatory writing experience

Tools

Microsoft Word

Job description

## Principal Medical Writer - Clinical FocusApply: Fully Remote: Massachusetts: Canada: United States: Full time: Posted Today: R-202609895**Job Description:****Position specific overview**Medical Writers prepare high quality documentation for regulatory submissions in order 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 teamsLearn more about our core values here!**What we offer**· The estimated hiring range for this role is $132K to $151Kplus 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:o Remote workingo Flexible time offo Paid holidayso Medical insuranceo Tuition reimbursemento Retirement plans**What we look for****Education, Experience, Training, and Knowledge:*** Bachelor’s degree (minimum)* 7+ years of regulatory writing experience with clinical- 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 (clinical documents, e.g***.,** Clinical Study Reports, Protocols, Investigator Brochures, ISS and ISE)* 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*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.### Equal Opportunity EmployerVeristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives. We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen. We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace. Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices. **Reasonable Accommodations**Veristat is dedicated to providing an accessible and inclusive application experience for all candidates. If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at [e-mail] or [phone]. We will work with you to meet your needs, ensuring a fair process. All requests in relation to your application will be treated confidentially. For more information about how we collect and store your personal data during the hiring process, please see our Career Recruitment Notice