Senior Medical Writer- Clinical Focus

Veristat•Massachusetts, MA

7d•$116,000 - $128,000•Remote

About The Position

The Senior Medical Writer- Clinical Focus is a major contributor to document authorship for a variety of documents across different service lines. The Sr Medical Writer will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Veristat is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals. 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!

Requirements

Bachelor’s degree
3+ years of regulatory writing experience or equivalent experience with clinical related documentation
Understand regulatory authority guidelines and requirements
Experience in the development of submission-level documents (does not require functioning as a document lead)
Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE
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

Responsibilities

Be the project lead on smaller projects, interfacing directly with the client.
Support larger, more complex engagements as a member of a larger delivery team.
Use expertise in clinical regulatory writing to lead teams and help clients achieve their goals.
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.
Conduct/lead a CRM and successfully lead a project team to consensus.
Use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others.
Develop professional relationships with clients as a way to further the business relationship and maintain current industry knowledge.
Identify and institutionalize work practices that are most effective in order to ensure consistency in performance.