Job Description:
• Major contributor to document authorship for a variety of documents across different service lines
• 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
Requirements:
• Bachelor’s degree
• 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
• Understand regulatory authority guidelines and requirements to be able 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
• Able 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.
Benefits:
• Remote working
• Flexible time off
• Paid holidays
• Medical insurance
• Tuition reimbursement
• Retirement plans
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Benefits:
- Health Insurance
- Paid Time Off
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