When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
We are seeking a Documentation Specialist (Medical/Technical Writing) to join a key Functional Service Provider program supporting one of our key sponsors.
As a Documentation Specialist (Medical/Technical Writing), you will work as an integrated member of the sponsor team, supporting the preparation and coordination of clinical development documents including Clinical Trial Reports (CTRs), Clinical Trial Protocols (CTPs) and amendments, Investigator Brochures (IBs) and updates, biomarker reports, and submission documents.
This role is ideal for a scientifically minded professional who enjoys working in a collaborative environment where accuracy, organization, and attention to detail are essential. You will support document development activities, coordinate administrative processes, and contribute to the delivery of high-quality clinical documentation that supports the advancement of innovative therapies.
Support the set-up and maintenance of clinical documents within the Electronic Document Management System (EDMS).
Review document status and assist with document workflow activities within sponsor systems.
Coordinate document timelines and support project teams by tracking key deliverables.
Prepare meeting materials and attend trial team and submission meetings, documenting actions and outcomes as required.
Support the organization and documentation of kick-off meetings and Results Alignment Meetings.
Draft sections of clinical documents and contribute to the preparation of tables, figures, and supporting content.
Coordinate document review activities and support the collection and incorporation of stakeholder feedback.
Assist with Quality Control activities and completion of required documentation.
Support preparation of final document packages for review, publishing, and archiving activities.
Complete technical and formatting checks for Investigator Brochures and related clinical documents.
Maintain accurate records and documentation in accordance with sponsor procedures and SOPs.
Experience supporting documentation needs in medical/technical writing, clinical documentation, or related clinical research activities.
Strong organizational skills and the ability to manage multiple document-related activities simultaneously.
Excellent written communication and attention to detail.
A collaborative approach and willingness to work closely with cross-functional teams.
A patient-focused mindset and commitment to quality.
Scientific degree and/or advanced scientific degree.
1-3 years of experience within a clinical environment, supporting medical/technical writing documentation.
Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes.
Experience working with document management systems and clinical development documentation.
Strong communication, organizational, and problem-solving skills.
If this job does not sound like the next step in your career, but perhaps you know someone who would be a perfect fit, send them the link to apply.
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
Originally posted on Himalayas