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Full-time
bachelor degree
Posted 8d ago
~40 hrs/week
Remote in United States
Responsibilities
The Senior Medical Writer is responsible for authoring, reviewing, and finalizing complex clinical documents for regulatory submissions while ensuring compliance with SOPs and guidelines. They also act as a project lead, managing timelines, coordinating team reviews, and maintaining collaborative relationships with clients.
Requirements
Candidates must possess a Bachelor's degree in Life Sciences or a related field and have extensive experience in clinical or scientific writing. A strong understanding of the drug development process, industry regulations like ICH-GCP, and proficiency in document management software are essential.
Full job description
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP has an exciting opportunity for a Medical Writer !
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.
#LI-KW1
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.
Related keywords
Medical WritingClinical TrialsRegulatory AffairsClinical Study ReportsProtocolsInvestigator BrochuresCTDFDAEMAICH-GCPProject ManagementQuality ControlLife SciencesDrug DevelopmentSOPsSharePoint
Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our 22,000+ global employees work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™ We continue to earn recognition industrywide, including the 2025 Scrip Award for “Best Contract Research Organization – Full-Service Provider,” 2024 Fierce Biotech CRO Award for "Innovative Approaches to Patient-Centric Research" and the 2024 and 2023 Society for Clinical Research Sites Eagle Award.
Community Guidelines
Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are:
• Abusive, harassing or threatening to others.
• Defamatory, offensive, obscene, vulgar or depicting violence.
• Hateful targeting by race/ethnicity, age, color, creed, religion, gender,
sexual preference or orientation, nationality or political beliefs.
• Sexually explicit or pornographic.
• Fraudulent, deceptive, libelous, misleading or unlawful.
• Referencing criminal or illegal activity.
• Spamming.
We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
Offices: 541 Church at North Hills St, 1000, Raleigh, North Carolina 27609, US
Regulatory and product development consultingearly phase clinical researchphase II-III clinical researchlate phase clinical researcheClinical solutionspatient and site recruitmentmedical device consultingclinical research organizationpharmacovigilancebiotechnology
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