Senior Medical Writer

Synterex, Inc.; New Jersey; Hybrid; USD 80,000 - 110,000; Full time

Job summary

Synterex, Inc. is seeking a Senior Medical Writer to join their team remotely. This role involves leading the planning and preparation of clinical regulatory documents while collaborating with various departments. The ideal candidate has over 5 years of experience in medical writing within the CRO/biotech industry.

This position requires excellent project management skills, familiarity with regulatory requirements, and proficiency in Microsoft Word. Interested applicants should reach out via [e-mail].

Qualifications

• 5+ years of experience as a medical writer in the CRO/biotech/pharmaceutical field.
• Familiarity with ICH and US regulatory requirements.
• Experience writing clinical study reports and protocols.

Responsibilities

• Lead the execution of documents and manage timelines.
• Coordinate client contributors and internal resources for timely document completion.
• Ensure adherence to client processes and templates.

Skills

Medical writing

Project management

Regulatory documentation

Conflict management

Strong communication

Education

Bachelor's degree or higher in a relevant field

Tools

Microsoft Word

Document management systems

Job description

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 to lead 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 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, 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 [e-mail].

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.