Remote Senior Medical Writer - Regulatory Submissions

Synchrogenix Information Strategies, LLC; Massachusetts; On-site; USD 132,000 - 151,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Paid holidays

Medical insurance

Tuition reimbursement

Retirement plans

Job summary

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents across product development stages. You will guide teams, synthesize data, and ensure SOP‑compliant submissions, with client‑facing advisory responsibilities and budget oversight.

The role emphasizes leadership in study‑level and submission‑level writing, cross‑functional collaboration, and coaching junior staff to meet regulatory standards.

Qualifications

• Bachelor’s degree (MS or PhD preferred).
• 7+ years of regulatory writing experience or equivalent experience with nonclinical sections of the CTD (e.g., Nonclinical Overview, Nonclinical Summaries, Pharmacology or Toxicology Reports, ADME Reports).
• Experience in the development of submission‑level documents and understanding of regulatory authority guidelines.

Responsibilities

• Work closely with client and internal and partner organization teams to develop strategies for organizing and preparing regulatory documents.
• Lead a project team and actively participate in development and writing of high‑quality study‑level, submission‑level, and pharmacovigilance documents.
• Author documents per client specifications, templates, style guides, and regulatory authority guidelines.
• Act as client advisor, building trust through reliable communication and providing strategic guidance.
• Practice blameless problem‑solving to resolve issues and prevent negative impacts.
• Manage the budget for low‑complexity projects, including writers and editors.
• Conduct comment‑resolution meetings (CRMs) and lead the project team to consensus.
• Maintain proactive, effective communication with clients and internal teams.
• Lead project‑related meetings and teleconferences.
• Provide coaching to junior staff on study‑level and submission‑level documents and ensure compliance with SOPs and training requirements.

Skills

Regulatory writing

Project leadership

Stakeholder communication

Blameless problem‑solving

Submission writing

Budget management

Coaching junior staff

Data synthesis

Education

Bachelor's degree (MS or PhD preferred)

Tools

Microsoft Word

Job description

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents across product development stages. You will guide teams, synthesize data, and ensure SOP‑compliant submissions, with client‑facing advisory responsibilities and budget oversight.

The role emphasizes leadership in study‑level and submission‑level writing, cross‑functional collaboration, and coaching junior staff to meet regulatory standards.