Parexel is looking for a Senior / Principal Medical Writer to join our Functional Service Provider (FSP) group. You will be responsible for developing and finalizing a wide range of clinical regulatory documents for a key client's sponsored studies.
What You'll Do
- Prepare, develop, and finalize key clinical documents—including clinical study reports (CSRs), narratives, study protocols, protocol amendments, and CTD sections (e.g., Modules 2.5 and 2.7)—for submission to regulatory authorities.
- Operate as the project lead writer/submission coordinator and primary client contact to manage contributions from multiple writers.
- Manage project scope, timeline, goals, technical information, and client input throughout the project lifecycle.
- Provide technical leadership to ensure data presentation complies with regulatory guidelines and SOPs.
- Revise document drafts based on review comments and ensure all work is high quality before distribution.
- Build and maintain collaborative relationships with teams and clients, fostering increased performance and inclusion.
- Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
- Keep abreast of new advances in medical writing and regulatory issues.
- Support business development efforts and contribute expertise to analyze proposed programs and related documents.
What We're Looking For
- A Bachelor's degree in Life Sciences or a Health Related Sciences field, or equivalent experience.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
- Previous advanced-level medical writing experience at either a Senior or Principal Medical Writer level.
- Broad experience preparing all types of clinical regulatory documentation, including CSRs, safety narratives, study protocols, protocol amendments, and CTD sections.
- Experience managing complex medical writing projects and knowledge of resource and productivity metric management.
- Advanced skills in MS Office, with expertise in Word, and the ability to adapt to various IT systems like document management systems, SharePoint, and Excel.
- Fluent English communication and excellent interpersonal, negotiation, and written communication skills.
- A flexible attitude towards new assignments and learning, with the motivation to work consistently in a fast-paced environment.
- Ability to manage multiple tasks, prioritize workload, work competently in a matrix environment, and value teamwork.
- Team leadership skills, cross-cultural sensitivity, sound judgment, and the ability to negotiate to align resources and timelines.
- A client-focused approach, with the ability to understand client needs and build trust to widen business scope.
Technical Stack
- MS Office (Word)
- SharePoint
- Excel
Team & Environment
You will be part of an FSP team, working with international peers, colleagues, and a supportive manager within a matrix structure.
Benefits & Compensation
- A structured career pathway with encouragement for development within the role.
- A competitive base salary.
- Holiday entitlement.
- Private healthcare.
- Other benefits expected from a top company in the CRO industry.
Work Mode
This is a global role, with positions available in Ireland, the UK, France, Poland, and Spain.
Parexel is an equal opportunity employer.
