Medical Writer (Manager)

ROLE SUMMARY

• The Medical Writer (Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
• Understands the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.
• Applies comprehensive knowledge of relevant regulatory requirements and corporate policies to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
• Is facile with innovative problem solving

ROLE RESPONSIBILITIES

• Independently authors moderately complex documents compliant with relevant internal processes and standards as well as external regulatory guidance.
• Manages all aspects of document development process. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Contributes to decision making about data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
• Develops and maintains project timelines. Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
• Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members.
• Identifies potential areas for process improvements and possible solutions and communicates them to line management or appropriate functional line.

BASIC QUALIFICATIONS

• Bachelor’s degree, preferably in a life science discipline.
• BS/BA +5 years, MS/MA +3 years, PhD +0 years of experience in medical writing or related field.
• Understanding of the role of each member of cross-functional team.
• Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
• Ability to manage documents of simple complexity and/or limited variety.
• Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
• Adapts to change as needed.
• Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
• Ability to identify complex problems that require management or cross-functional input for resolution in timely manner
• Chooses between multiple options to resolve moderately complex problems that impact project completion.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains …