Senior Medical Writer - Safety Focus

Veristat•Massachusetts, MA

8d•$116,000 - $128,000•Remote

About The Position

The Senior Medical Writer - Safety Focus is a major contributor to document authorship for a variety of aggregate safety reports within the safety service line. The Medical Writer - Safety Focus 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. 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 or higher, in a scientific discipline strongly preferred.
2 to 5+ years of regulatory writing experience with aggregate safety report writing including: Development safety update reports (DSURs), Periodic safety update reports (PSURs), Periodic benefit-risk evaluations reports (PBRERs), Risk management plans (RMPs), Periodic adverse drug experience reports (PADERs), Addenda to clinical overviews (ACOs), Safety topic reviews.
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 work in a collaborative environment, be tolerant of differences in culture and beliefs, easily build relationships with others, openly share information, and willingly contribute toward accomplishment of team goals.
Be action- and detail-oriented, always seeking new development opportunities to build knowledge and skills.
Show flexibility to meet project needs as required by deadlines and to meet corporate goals and objectives.
Remain knowledgeable of changes in the industry and adapt best practices.
Demonstrate solid time management and other organizational skills.

Nice To Haves

Experience in the development of aggregate safety reports.

Responsibilities

Document authorship for a variety of aggregate safety reports.
Project lead on smaller projects, interfacing directly with the client.
Support larger, more complex engagements as a member of a larger delivery team.
Understand regulatory authority guidelines and requirements 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.
Synthesize data across multiple data sources and documents to create summary reports.
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 to further the business relationship and maintain current industry knowledge.
Identify and institutionalize work practices that are most effective to ensure consistency in performance.