Principal Medical Writer - Nonclinical Focus

Veristat•Massachusetts, MA

1d•$132,000 - $151,000•Remote

About The Position

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.

Requirements

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
Experience in the development of submission-level documents
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
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

Nice To Haves

MS or PhD

Responsibilities

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.
Collaborating with cross-functional internal and external document production teams.
Leading an internal project team and anticipating the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance.
Providing subject matter guidance for quality document preparation, document review, accurate comment resolution/incorporation, and document finalization.
Owning 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.
Developing professional relationships with clients as a way to further the business relationship and maintain current industry knowledge.
Identifying and institutionalizing work practices that are most effective in order to ensure consistency in performance.
Resolving problems that arise, particularly in sensitive or high-pressure situations.
Integrating broad experience and technical expertise across more than one therapy area to deliver business successes and actively transferring this knowledge to strength the skill base across the organization.