Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future
We are seeking a Clinical Publisher to join our FSP team on a 1 year fixed term contract with a start date by end of January 2026.
In this role, you will collaborate with program lead writers to support the development of complex clinical, nonclinical, and safety documents for regulatory submissions. You will contribute to the execution of medical writing strategies and ensure all deliverables align with organizational standards, regulatory requirements, and quality expectations.
Key Responsibilities
* Develop and publish high-quality clinical and regulatory documents including, but not limited to, Clinical Study Reports (CSRs), Aggregate Safety Reports (ASRs), and submission-ready summary documents.
* Compile and publish documents according to submission-ready standards within defined timelines that meet internal, ICH, and industry guidelines.
* Conduct document-level quality control (QC) reviews to ensure accuracy, consistency, and functionality (e.g., Acrobat bookmarks, internal hyperlinks) for clinical and regulatory documentation.
* Maintain document lifecycle management through accurate metadata entry and adherence to electronic document management system (EDMS) requirements.
* Provide recommendations based on QC findings to support process improvements, training initiatives, and increased operational efficiency and consistency.
* Serve as a central resource during cross-functional team meetings to ensure document accuracy, consistency, and adherence to established templates, processes, and standards.
* Perform PDF rendering checks, proofreading, and formatting/reformatting to ensure documents conform to organizational standards and are submission-ready.
* Contribute to the development and refinement of standards, processes, and technology tools supporting major submission activities.
* Proactively identify and resolve publishing issues in collaboration with cross-functional teams to ensure timely and high-quality submission deliverables.
* Assist with bookmarking and hyperlinking of scanned legacy documents.
* Apply advanced word processing skills, including use of templates and macros, to support document development and formatting.
Required
Required & Preferred Qualifications
* Bachelor's degree
* 2–3 years of document-level clinical publishing experience in the biotechnology or pharmaceutical industry
* Strong understanding of ICH guidelines, including E3 and E6
* Ability to organize and synthesize large volumes of complex information
* Excellent verbal and written communication skills
* Strong attention to detail, accuracy, and clarity
* Demonstrated ability to work collaboratively and cross-functionally
* Advanced word processing skills (e.g., use of custom MS Word templates and macros) for template development and updates
Preferred
* Familiarity with AMA Manual of Style
* Experience with advanced formatting tools and workflow optimizations
Technical Skills & Tools
Document Management Systems (DMS):
* Veeva Vault
Authoring & Publishing Tools:
* MS Word
* ISIWriter
* Starting Point Templates
* Adobe Acrobat Pro
Other Tools:
* Microsoft Office Suite
* MS Project
* PleaseReview
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.