Description

Principal/Senior Medical Editor (QC) - 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

Roles and Responsibilities:

Determines scope of quality control review with the author and the source documents and/or data required.  Conducts independent quality control review of documents with applicable checklist by checking against source to ensure that the results presented are accurate (emphasis on checking the numbers/data in the text and in-text tables against the final statistical tables, listings, and graphs (TLGs).  Deliver documented quality control review comments/checklist to author through resolution.Ensures quality control review documentation is completed from all areas and provided/uploaded to the applicable master file(s) per the established business processes and procedures.Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas.  Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable.Accountable for meeting the main objectives/deliverables of the assigned projects/roles and responsibilities within established timelines with a high level of quality, consistency, and accuracy. For example, passing acceptance criteria for quality audits based on statistical sampling plan and defined error threshold is expected. If re-QC is required, QC should be performed by an individual who did not perform the initial QC.

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.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

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.

Summary

Responsible for ensuring the quality of clinical regulatory submission documents by conducting quality control review utilizing checklists as well as ensuring that the quality control review documentation is provided to the applicable master file(s) per the established business processes and procedures.