Principal Medical Writer

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: No
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**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Work-life Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Career Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Home based**: Love where you work, and work where you love.
- **Variety**: Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

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 at for clinical writing.

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.

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 com