Job Description

Synterex, Inc. is a global 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 senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in leading the planning and preparation of high-quality clinical regulatory documents. The medical writer may produce protocols, publications, study reports, investigator brochures, narratives, and module documents, according to client and agency guidelines, to support drug development under brisk timelines.

Location: Fully remote, but must be able to attend key (e.g., roundtable or kickoff) meetings on site with clients as requested.

Essential Duties & Responsibilities

Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
Coordinate cross-functional client contributors and stakeholders as well as internal resources (e.g., quality control [QC], publishing) to ensure timely completion of documents
Ensure document development adheres to any relevant client processes, templates, and instructional documents
Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
Lead document message development in collaboration with client
Interpret data and create shell documents to support authoring
Plan and lead kickoff meetings
Facilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient)
Follow-up with individual team members as needed to resolve outstanding review feedback
Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
Conduct literature searches as needed
Perform peer QC review as needed

Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed

Requirements

Experience (5+ years) as a medical writer in the CRO/biotech/pharmaceutical field
Bachelor’s degree or higher in a relevant field
Oncology, Infectious Disease, or Vaccine experience desired
Experience desired in writing clinical study reports, protocols, protocol amendments, investigator brochures, module 2, and module 5 documents
Flexibility to work across multiple therapeutic areas, if needed
Experience writing documents according to established processes and document templates
Familiarity with lean authoring approaches and structured content management
Familiarity with the requirements for preparation of key clinical and regulatory documents, including ICH and US regulatory requirements; working knowledge of ex-US regulatory requirements is desired
Expertise with Microsoft Word and other Microsoft applications
Experience developing documents using document management systems, collaborative authoring tools, and review tools
Comfortable adapting to new tools and technologies, if needed
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
Comfortable providing suggestions based on previous experience
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. 

Synterex participates in the Department of Defense’s SkillBridge program. For more information, please visit www.synterex.com/fellowships-internships.

Synterex

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