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 our UK Head Office situated in Uxbridge or can be home-based in the UK. We are near to both Uxbridge train station as well as the town centre and the building has plenty of free parking. The office is open planned, and you will be working in an innovative and collaborative environment.
As the Medical Writer I you will work under departmental supervision, you will research, create, edit, and coordinate the production of clinical documents, including model informed consents, interim and final clinical study reports, and safety update reports. You may also provide writing support for more complex clinical documentation, with appropriate departmental supervision as well as serve as primary contact with clients under appropriate departmental supervision.
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
– 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.
– 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.
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,
– 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.
– Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
– Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.
– 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.
– 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. Managemultiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g.,
– 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 moderate clinical/scientific writing skills and a basic understanding of different types of clinical regulatory documentation
– 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
– If required to perform translation work and quality control
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!.