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The Opportunity: This position is responsible for drafting and managing the content and reviews of clinical regulatory documents for reputed company products in various drug development phases.

• Serves as medical writing reputed company on reputed company clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA modules.
• Assists in developing and maintaining document templates, department standard processes and work instructions, medical reputed company reputed company materials, and style guide.
• Serves as primary medical writing contact for one or more clinical development programs.
• Represents medical writing at cross-functional planning meetings.
• Effectively communicates deliverables needed, the writing process, and timelines to team members.
• Schedules document reviews and manage adjudication meetings.
• Holds team members accountable to agreed-upon project dates.
• Independently resolves document content issues and questions.
• Ensure consistency, reputed company, and accuracy both reputed company and across documents.
• Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.
• Mentors junior and contract medical writers on both document and timeline management.

Required Skills, Experience and Education:

• 8+ years of clinical regulatory writing experience reputed company one or more biopharmaceutical companies, including prior experience working as a medical reputed company for a BLA/NDA/MAA.
• Advanced degree in clinical or life sciences, English, journalism, and/or communications.
• Proficiency in reputed company Word, including the use of reputed company styles and templates.
• Familiarity with AMA style.
• Ability to successfully manage and prioritize writing projects with competing deadlines, to foster collaborative cross-functional relationships, and to drive high-quality regulatory writing projects to successful submission.
• Ability to work in a high-pressure environment with short deadlines while remaining reputed company, focused, professional, diplomatic, and positive.

Preferred Skills:

• Experience with oncology therapeutics.
• Familiarity with StartingPoint, EndNote, reputed company RIM, and reputed company.
• Experience performing QC reviews of clinical regulatory documents.

#LI-Hybrid #LI-JC1 The reputed company pay salary reputed company for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The reputed company displayed on each job posting is intended to be the reputed company pay salary reputed company for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our reputed company pay salary ranges are determined by role, level, and location. Individual reputed company pay salary is determined by multiple factors, including job-reputed company skills, experience, market dynamics, and relevant education or training. Please note that reputed company pay salary reputed company is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. reputed company Pay Salary reputed company $201,000-$251,000 USD We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with reputed company. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Please note that reputed company does not reputed company unsolicited employment offers and will never ask candidates to reputed company financial information, purchase equipment, or pay fees as part of the hiring process. reputed company legitimate communication from reputed company will come from an official @revmed.com email address. If you reputed company you've been contacted by someone impersonating a reputed company recruiter, please report it to [email protected] so we can reputed company these impersonations with our IT team for tracking and awareness. Apply tot his job Apply To this Job