Syner-G BioPharma Group

Consultant I, Medical Writing

Syner-G BioPharma Group

full-time

Posted on:

Location Type: Remote

Location: United States

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Tech Stack

Vault

About the role

  • Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials.
  • Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications).
  • Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines.
  • Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands.
  • Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines.
  • Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust.
  • Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.
  • Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents.
  • Contribute to the development of regulatory strategies for early-stage and smaller clients.
  • Provide guidance on tools, document management systems, and client SOPs.
  • Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship.

Requirements

  • An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.
  • RAC certification is beneficial.
  • 3+ years industry experience
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Teams, and MS Project.
  • Familiarity with regulatory document management systems, such as Veeva Vault.
  • Experience with regulatory submissions and understanding of global regulatory standards.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory documentsClinical Study Reportsstudy protocolsquality controlsubmission-readiness processesregulatory submissionsdocument management systemsregulatory strategiesproject managementtimelines
Soft Skills
client interactionscommunicationproject ownershipproblem-solvingcollaborationtrust buildingadaptabilityattention to detailtime managementcontinuous learning
Certifications
RAC certification