Medical Editor
Syneos Health, Inc.
Principal/Senior Medical Editor (QC) - Home Based
Location: BRA-Remote
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.
Why Syneos Health
technical and therapeutic area training; 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
Learn more about Syneos Health.
Further, nothing contained herein should be construed to create an employment contract. 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.
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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace. We also encourage you to join our Talent Network to stay connected to additional career opportunities.
We work hard,and smart, all in the name of getting much-needed therapies to thosewho need them most. A career with Syneos Health means your everyday work improvespatients’ lives around the world. Syneos Health® (Nasdaq: SYNH) is a leading integrated biopharmaceutical solutionsorganization built to accelerate customer success. We translate unique clinical,medical affairs and commercial insights into outcomes to address modern marketrealities. Syneos Health is an Equal Opportunity Employer. All qualified applicants will receiveconsideration for employment without regard to race, color, age, religion, marital status,ethnicity, national origin, sex, gender, gender identity, sexual orientation, protectedveteran status, disability or any other legally protected status and will not bediscriminated against.
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