What are the responsibilities and job description for the Non-Clinical Writer position at Synterex?
Synterex, Inc. is a consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.
Synterex is seeking an organized, motivated, and collaborative individual for our medical writing team. The nonclinical medical writer will partner cross-functionally with client teams in Research and Development, Nonclinical Development (Pharmacology, Toxicology, Pharmacokinetics), Clinical Pharmacology, Clinical Operations, Biostatistics, Regulatory, Program Management, and Chemistry, Manufacturing, and Controls in planning and preparation of high-quality nonclinical and regulatory documents. The medical writer may produce nonclinical protocols, study reports, investigator brochures, regulatory documents, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.
Initial contract length: 3 to 6 months, with potential for extension or conversion to FTE.
Location: Fully remote position, preferred ability to attend roundtable meetings on site with clients as requested.
Essential Duties & Responsibilities
- Manage execution of documents, including creation, maintenance, and communication of timelines
- Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing)
- Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document production
- Lead document messaging in collaboration with client
- Plan and lead kickoff meetings and roundtable meetings for each document draft; vet comments post team review to ensure efficient roundtable meetings
- Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
- Perform peer QC review as needed
- Contribute to medical writing operational initiatives (eg, templates, style guides, reference management)
Requirements
- Subject matter expertise in nonclinical
- Experience (3 years) as a medical writer in the CRO/biotech/pharmaceutical field, or equivalent
- Bachelor’s degree in a relevant field
- Familiarity with the requirements for preparation of key nonclinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of other ex-US regulatory requirements is desired
- Expertise with Microsoft Word and other Microsoft applications
- Familiarity with document management systems
- Ability to work both independently and collaboratively in the face of competing priorities
- Service-oriented and proactive approach to project management
- Excellent conflict management and negotiation skills
- Strong written and verbal communication skills
For further information or to apply, please reach out to careers@synterex.com.
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
