Medical Writer II Job at Parexel in United Kingdom
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.
Check out the top traits we’re looking for and see if you have the right mix.
We are one truly global team working together to propel each client´s journey ahead faster.
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
Opportunity to learn and grow through a performance and development goal-setting program.
Love where you work, and work where you love.
Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
This role can be based at either our UK Head Office situated in Uxbridge or in our Spanish Head Office in Madrid or home-based in either the UK/Spain respectively. The offices are open planned, and you will be working in an innovative and collaborative environment.
As the Medical Writer II you will work under departmental supervision, you will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. You will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. You may also serve as the primary client contact.
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: study protocols, 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.
- 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.
Document Project Management
- 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 (if needed):
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.
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).
- 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.
- Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.
- 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. Possesses team leadership skills and crosscultural sensitivity.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
- Strives to understand and satisfy 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.
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 study reports.
- 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.
In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, as well as a benefits package including 25 days holiday per year, a strong contributory pension scheme, life assurance, long term disability insurance, private medical and private dental cover as well as other leading-edge benefits that you would expect with a company of this type.
Apply today to begin your Parexel journey!
Company Location: United Kingdom