CSR Appendices Coordinator - Home Based

Syneos Health, Inc.; Greater London; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biopharmaceutical solutions organization in Greater London is seeking to fill a role responsible for authoring Clinical Study Report (CSR) Appendices and managing clinical and regulatory references. The successful candidate will define the scope of CSR documents, ensure completeness of regulatory documents, and facilitate effective communication with stakeholders. Applicants should have strong interpersonal and organizational skills, and be able to handle multiple tasks effectively. This position offers a supportive work culture and opportunities for professional development.

Benefits

Career development opportunities

Supportive work culture

Total rewards program

Qualifications

• Strong knowledge of Clinical Study Reports (CSR) and Appendices.
• Ability to handle multiple tasks within overlapping timeframes.
• Experience in compiling and organizing regulatory documents.

Responsibilities

• Define scope of Clinical Study Reports with the document author.
• Confirm completeness of regulatory documents and maintain strong knowledge of CSRs.
• Communicate deliverables needed to stakeholders effectively.

Skills

Interpersonal communication skills

Organizational communication skills

Conflict management skills

Tools

Regulatory information management systems (RIMS)

Job description

Updated: November 13, 2025. Location: London, LND, United Kingdom. Job ID: 25103128-OTHLOC-3526-2DR

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

• Defines scope of Clinical Study Reports (CSR) Appendices with the document author. Coordinates and tracks activities and performs detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS).
• Confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (RIMS). Maintain strong knowledge of CSR and CSR Appendices and CTD structure.
• Effectively communicates deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
• Effectively attends to multiple tasks within overlapping timeframes; builds positive and productive relationships that enable high quality documents to be completed on time.

Additional Information

The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

All other standard equal opportunity statements as required by law.

Summary

Responsible for authoring of Clinical Study Report (CSR) Appendices and managing clinical and regulatory references.