Senior Medical Writer – 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 Senior Medical Writer is responsible for writing, editing and reviewing clinical study documents according to global agency 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), investigational medicinal product dossiers (IMPDs), informed consent forms (ICFs), annual reports, clinical study reports (CSRs), feasibility reports, Integrated Summary of Safety and Efficacy reports (ISS/ISE), and 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:
- Interprets clinical study results and write, review and/or edit clinical study documents.
- May translate clinical study documents.
- Performs QC reviews on documents developed by other writers.
- Prepares scientific manuscripts, abstracts, posters.
- May review scientific literature, product information and evaluate product data.
- Assists in the development of formats and guidelines for clinical documents.
- Trains other medical writers.
- Reviews of work products of junior staff.
- May cross-train individuals from other departments in QC review of CSRs.
- Assists with writing and/or reviewing of SOPs.
- May serve as the primary point of contact for MW on project teams.
- Keeps abreast of professional information and technology, industry practices and regulatory guidance affecting medical writing through attendance at conferences or professional meeting.
- Archives clinical documents prepared by the medical writing group.
- Conducts activities within budget requirements as instructed by the Project Manager.
- Advanced degree in a scientific, medical or statistical discipline and at least 5 years experience or equivalent combination of education and experience.
- Familiarity with relevant ICH, CTD/eCTD and FDA guidances, and GCP
- Familiarity with medical terminology.
- Excellent Proficiency in Microsoft Word, Excel, PowerPoint, Outlook, Internet Explorer and Adobe Acrobat.
- Effective verbal and writing skills; English + local language, if relevant
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.