Senior Medical Writer - FSP

Key Accountabilities

• Author Clinical Documents
• Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents.
• Revise document drafts based on review comments from team members.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes.
• Perform literature searches/reviews as necessary.
• Review statistical analysis plans and mock statistical output.

Quality Control

• Ensure all work is complete and of high quality prior to team distribution or shipment to client.
• Confirm data consistency and integrity across the document.
• Prepare documents for publishing readiness, when applicable.
• Ensure document structure, content, and style adhere to regulatory guidelines.
• Provide suggested alternative content when contributors provide content that does not meet document needs.
• Provide medical editing review of draft and final documents.

Document Project Management

• Act in the capacity of project manager/lead for medical writing projects.
• Communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents.
• Schedule and lead/facilitate authoring team meetings.
• Evaluate progress on tasks, identify issues and facilitate resolutions.
• Manage/drive the timeline, and advance document development to approval.
• Distribute final documents to project team and client.
• Identify potential project challenges and suggest possible resolution options.
• Mediate conflict or disagreement among team members.

Training/Compliance

• Attend and complete mandatory, corporate, project-specific, and departmental training.
• Keep abreast of professional information and technology through workshops and conferences.
• Assist in the training/mentoring of new staff.

Skills

• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently produce documents of high quality.
• Demonstrates attention to details and proactivity.
• Flexible attitude with respect to work assignments and new learning.
• Efficiently manages time spent on tasks and proactively identifies deficiencies.
• Manage multiple and varied tasks with enthusiasm and prioritizes workload with attention to detail.
• Competent working in a matrix environment and values the importance of teamwork.
• Possesses team leadership skills and cross-cultural sensitivity.
• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
• Understands and satisfies client needs.
• Gains trust and establishes a connection with the client beyond one's project.
• Provides departmental expertise and perspectives to promote prospective business opportunities.
• Provides Parexel colleagues with pertinent information to formalize a sound business strategy.

Knowledge and Experience

• Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations.
• Extensive clinical/scientific writing skills.
• Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar.
• Advanced word processing skills, including MS Office (expertise in Word).
• Software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).

Education

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.