Responsibilities:

• Lead medical writing activities associated with individual studies, defining document strategy and coordinating medical writing activities within and across departments with minimal supervision.
• Complete a variety of documents, including clinical study protocols, clinical study reports, patient narratives, and abstracts.
• Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, and client standards.
• Advise clients and study teams on data presentation and production strategies to ensure client objectives are met and quality standards are maintained.
• Lead team document reviews and review documents for technical issues.
• Serve as expert peer reviewer for internal team, providing review comments to ensure client objectives are met and overall quality standards are maintained.
• Interact and build good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate.
• Mentor and lead less experienced medical writers on complex documents.
• Develop deep expertise on key topics in the industry and regulatory requirements and guidelines that affect medical writing.

Benefits:

• Company car or car allowance
• Health benefits, including 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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