CSR Appendices Coordinator - Home Based

Syneos Health group; City of London; On-site; GBP 40,000 - 60,000; Part time

Job summary

A leading biopharmaceutical solutions organization is seeking a CSR Appendices Coordinator. This role involves authoring Clinical Study Report Appendices, coordinating document activities, and ensuring quality reviews. Ideal candidates will have strong interpersonal and organizational skills. This part-time position is based in London, England, and offers an opportunity to be part of a team that drives innovation in patient outcomes.

Qualifications

• Strong knowledge of CSR and CSR Appendices.
• Ability to manage multiple tasks within overlapping timeframes.
• Experience in quality reviews and regulatory information management systems.

Responsibilities

• Defines scope of CSR Appendices and tracks activities.
• Confirms completeness of documents and maintains their organization.
• Communicates deliverables to stakeholders effectively.
• Builds positive relationships to complete quality documents on time.

Skills

Interpersonal communication

Organizational skills

Conflict management

Job description

CSR Appendices Coordinator - Home Based

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.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE. 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.

Summary

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

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. 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.

Seniority level

Not Applicable

Employment type

Part-time

Job function

Other

Location

London, England, United Kingdom

Referrals

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