Sr Medical Writer, Regulatory (Home-based, US and Canada)

Description:
• Senior medical writer on clinical study or regulatory project teams.
• Writes, edits, and coordinates content for clinical/regulatory documents while serving as the primary technical contact with the internal team and the client.
• Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
• Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings.
• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completing medical writing projects, on time and on budget.
• Coordinates quality and editorial reviews.
• Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
• Interacts and builds good working relations with clients, department head, and peers in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables.
• Mentors and leads less experienced medical writers on complex projects, as necessary.

Requirements:
• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
• Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide
• Experience writing relevant document types required.
• Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.

Benefits:
• Health benefits to include Medical, Dental and Vision
• Company match 401k
• eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• flexible paid time off (PTO) and sick time

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