Medical Writer - Remote (Anywhere, US)
This position can be located anywhere in the US.
Who We Are
Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies. With our mission of "Bringing Clinical Trials to Life," we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations. Our mission is to support the innovation and development of better therapies in healthcare.
The Medical Writer is responsible for writing, editing and reviewing clinical study documents according to global regulatory guidance, templates, style guides and standard operating procedures (SOPs). Clinical study documents may include but are not limited to study protocols and amendments, investigator brochures (IBs), informed consent forms (ICFs), annual safety reports, clinical study reports (CSRs), Integrated Summaries of Safety and Efficacy (ISS/ISE), and other sections of regulatory applications (IND, IDE, NDA, BLA and PMA submissions). Other scientific documents (including but not limited to manuscripts, abstracts, posters) may also be developed.
Specific tasks would include:
Interpret clinical study results and write, review and/or edit clinical study documents
Perform quality reviews on documents developed by other writers
Prepare scientific manuscripts, abstracts, posters
Review scientific literature, product information and evaluate product data
Assist with writing and/or reviewing SOPs
Serve as the primary point of contact for MW on project teams
Conduct activities within budget and timeline requirements
Degree in a scientific or medical discipline and 2-4+ years' experience or equivalent combination of education and experience. Advanced degrees (e.g., PhD, MS, MPH) preferred.
Familiarity with relevant ICH, GCP, CTD/eCTD and FDA guidances,
Familiarity with medical terminology
Excellent proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer and Adobe Acrobat.
Effective verbal and writing skills; English
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.