CSR Appendices Coordinator - Home Based Job Jamestown New York USA,Healthcare

Location: Town of Poland

Updated: Yesterday
Location: POL-Remote
Job :

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. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels 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. Imports and routes documents in the regulatory information management systems (RIMS).

Confirms completeness of documents (e.g., Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (RIMS). Maintains strong knowledge of CSR and CSR Appendices and CTD structure.

Effectively communicates deliverables needed to stakeholders. Demonstrates good interpersonal and organizational communication skills, including conflict‑management skills.

Managing multiple tasks within overlapping time frames; builds positive and productive relationships that enable high‑quality documents to be completed on time.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

Legal & Equal Opportunity

Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against. If you are an individual with a disability who requires a reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at:

Phone: 919‑876‑9300
Fax: 919‑876‑9360
Toll‑Free: 866‑462‑7373

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