Medical Writer I/II

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Key Accountabilities:

Author Clinical Documents

Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to model informed consents, interim and final clinical study reports, and safety update reports. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. Perform literature searches/reviews as necessary to obtain background information and training for development of documents. Under appropriate departmental supervision as needed, review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing

Quality Control

Ensure that 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 adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.

Document Project Management

Under departmental supervision, serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues. Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership, with departmental supervision: communicate content requirements, coordinate, and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. Attend or lead project team meetings as required. With departmental supervision, mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator Develop collaborative relationships with teams/clients for a productive and professional working relationship. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

Training/ Compliance

Attend and complete mandatory, corporate, project-specific, and departmental training as required. Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department Provide guidance to new staff as well as less experienced departmental members

General

Attend departmental and company meetings as necessary. Comply with departmental procedures, such as completion of project assignment and workload trackers. Attend departmental and company meetings as necessary. May participate in departmental or interdepartmental process improvement and training initiatives.

Skills:

Excellent interpersonal, verbal, and written communication skills. Ability to consistently produce documents of high quality. Demonstrates attention to details and proactivity. Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. A flexible attitude with respect to work assignments and new learning; readily adapts to changes. Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Strives to understand and satisfy client needs.

Knowledge and Experience:

Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Good clinical/scientific writing skills. Scientific background essential; writing experience of regulatory documents such as patient narratives, informed consent forms or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications. Good word processing skills, including MS Office (proficiency 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). Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.

Education:

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

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