Senior / Principal Medical Writer - FSP

When our values align, there's no limit to what we can achieve. 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. We believe in our values.

The FSP team fulfills key clinical development roles across a variety of functional disciplines including medical writing. As the Senior / Principal Medical Writer, you will support clinical study reports (CSRs), including narratives, plus study protocols and protocol amendments, common technical document (CTD) sections (e.g., Modules 2.5 and 2.7) and other documents for submission to regulatory authorities for one of our key clients sponsored studies.

The role can be based in either location and can be remote. You will be working in an innovative and collaborative environment with international peers, colleagues and a supportive manager.

• 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.
• 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.
• Quality Control: 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.
• Project Management: 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 analyse 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.
• Client Liaison/Service: 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.
• Training/Compliance: 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.
• 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.

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/varied tasks with enthusiasm and prioritise workload with attention to detail.
• 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 formalise a sound business strategy.

• Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
• Previous advanced level medical writing experience operating at either Senior or Principal Medical Writer level, being able to demonstrate broad experience in preparation of all types of clinical regulatory documentation.
• Experience with clinical study reports (CSRs), Safety narratives, study protocols and protocol amendments, common technical document (CTD) sections particularly Modules 2.5 and 2.7 is essential.
• 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).
• Fluent English communication skills in both written and verbal format.

In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and in return for your hard work you will be rewarded with a competitive base salary and a benefits package including holiday, private healthcare as well as other benefits that you would expect with a top company in the CRO Industry.