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 Principal Medical Writer you will research, create, and edit all documents associated with clinical research. You may also operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. You will also facilitate process improvement and technical mentoring/training as well as support Medical Writing Services management during the sales process by providing client liaison and proposals input.
Author Clinical Documents
– Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training.
– Train self and provide guidance to others to prepare any type of medical writing deliverable.
– Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
– Manage ongoing and/or revised project documentation and correspondence.
– Ensure that all work is complete and of high quality prior to team distribution or; shipment to client.
– Provide technical leadership to ensure clinical data presented in summary; documents is in compliance with applicable regulatory guidelines, SOPs, and; goals of submission.
– Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents.
– Manage scope of work, timeline and project goals,technical information, and input from clients throughout the project.
– Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences.
– Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence.
– 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.
– Keep abreast of new advances in medical writing and regulatory issues.
– Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
– Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent
– Excellent interpersonal, negotiation, verbal, and written communication skills.
– A flexible attitude with respect to work assignments and new learning.
– Motivation to work consistently in a fast-paced, rapidly changing environment.
– Ability to 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.
– Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.
– Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
– Understands and satisfies client needs.
– Establishes a connection with the client beyond one’s project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.
– 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 applicable regulatory guidelines and regulations.
– Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.
– Knowledge of resource management and productivity metric management.
– 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).
– Ability to trave – adhoc
-Fluent in written and spoken English.
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!