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Synteract is an innovative CRO providing full-service, Phase I-IV services to biopharma companies in bringing new medicines to market. We align our operational excellence, therapeutic expertise and the right technology to support each clients clinical development needs. Over its nearly 30-year history, Synteracts leadership has been proven in the core dev...
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About the job
Who We Are
Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. W e provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.
The Medical Writing Editor is responsible for providing technical writing and editing support of various regulatory and clinical research technical documents, including clinical trial protocols, clinical study reports, informed consent forms, investigator’s brochures, and other regulatory documents. Copy editor duties are focused on proofreading documents for text, content, and syntax consistency to facilitate the successful production and completion of such deliverables with quality. Provides communication support between medical writers, internal personnel, and clients. Provides quality review (QR) of documents as well as document finalization. Performs literature and reference research activities to support medical writers and regulatory professionals
Specific Tasks Would Include
Primarily reviews, proofreads, edits, updates, corrects, formats, and makes improvement suggestions for project-related clinical study documents.
Reviews material for grammar, spelling, punctuation, correct medical terminology, typographical errors, and formatting.
Checks accuracy of content and ensures style consistency.
Verifies data against original sources for quality control.
Verifies correct implementation of internal and client changes.
Ensures timelines are promptly met.
Assists in compiling documents into a final product.
Takes the initiative to be proactive and search out tasks before they are given.
Performs data/content verification and reference checks information as required.
Adheres to Synteract Style Guide, AMA style guidelines, or sponsor preferences.
Interacts with internal specialists and Synteract consultants when appropriate.
Participates in corporate initiatives and actions that ensure the continued success of the company.
Provides a variety of technical skills, especially in programs such as Microsoft Office and Adobe Acrobat.
May develop and maintain macros-enabled document templates.
Maintains working knowledge of applicable industry guidelines and regulations.
Maintains working knowledge, reviews, and updates departmental controlled documents as required.
Other activities as designated.
Bachelor’s degree or its international equivalent from an accredited institution.
Scientific/technical background preferred.
2 to 4 years of related experience (clinical trials, publishing, writing, or editing), with at least three years of medical editing experience in a regulated environment, preferably in the pharma/biotech/CRO sector.
Experienced in Microsoft Office and Adobe Acrobat.
Working knowledge of GCP, ICH and FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development.
Demonstrated knowledge of web-based communication tools and various technical programs, including but not limited to Adobe, Microsoft Office, etc.
Strong knowledge of AMA style guidelines.
Demonstrated mastery of grammar, punctuation, and spelling.
If you’re passionate about bringing clinical trials to life, we encourage you to apply today!
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.
Note: Never pay for any training, certificate, assessment, or testing to the recruiter.
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