Senior Medical Writer - clinical focus

Senior Medical Writer – Clinical Focus

Position:
Senior Medical Writer – Clinical Focus. The Senior Medical Writer is a major contributor to document authorship across different service lines. The Sr Medical Writer will be the project lead on smaller projects, interfacing directly with the client, and also support larger, more complex engagements as a member of a larger delivery team.

Estimated hiring range: $116K to $128K plus applicable bonus (US only). Benefits vary by location and may include: remote working, flexible time off, paid holidays, medical insurance, tuition reimbursement, retirement plans.

• Bachelor’s degree.
• 3+ years of regulatory writing experience or equivalent experience with clinical related documentation.
• 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.
• 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.
• Ability to synthesize data across multiple data sources and documents to create summary reports.
• Ability to conduct/lead a CRM and successfully lead a project team to consensus.
• Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others.
• Develops 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.

Veristat is an equal‑opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 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.