Senior Medical Writer, Medical Writing

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Requirements:

• 5+ years of clinical regulatory writing experience within a biopharmaceutical company.
• Advanced degree in clinical or life sciences, English, journalism, and/or communications.
• Proficient in Microsoft Word.
• Familiar with AMA style.
• Detail-oriented with a focus on spelling, punctuation, grammar, and formatting.
• Able to manage and prioritize writing projects with competing deadlines.
• Able to foster strong collaborative relationships with clinical development team members.
• Outstanding interpersonal and communication skills.

Responsibilities:

• Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, and IND and NDA modules.
• Manages multiple and overlapping document timelines in a dynamic environment.
• Effectively communicates deliverables needed, the writing process, and timelines to team members.
• Schedules document reviews in PleaseReview and manages adjudication meetings.
• Holds team members accountable to agreed-upon project dates.
• Independently resolves document content issues and questions.
• Ensures consistency, clarity, and accuracy both within and across documents.
• Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.
• Assists the Senior Director, Medical Writing, and mentors junior and contract medical writers, as needed.