Principal Medical Writer

Job Summary:

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.

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: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.

• 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.

• 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 suggested alternative content when contributors provide content that does not meet document needs.

• 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

• Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.

• Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: 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. 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.

• Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship.

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.

• Assist in the training/mentoring of new staff as well as less experienced departmental members.

General

• Attend departmental and company meetings as necessary.

• Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform.

• When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents.

• Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures.

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.

• 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 establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.

• Provides departmental expertise and perspectives to promote prospective business opportunities; provide 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, e.g., ICH-GCP.

• 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).

• 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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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.