Medical Writer Clinical Development

The Fountain Group is currently seeking a Medical Writer  for a prominent client of ours. This position is Remote – Marlborough, MA . Details for the position are as follows:

Medical Writer – Clinical Development
Location: Remote – Marlborough, MA
Pay Rate: $76.13/hr
Duration: 7 months
Estimated Hours: 30–40 hours/week

Job Description

The Medical Writer – Clinical Development will author, edit, and review clinical and regulatory documents supporting global clinical development programs. Responsibilities include:

• Author clinical study protocols and protocol amendments, Investigator Brochures (IBs), Clinical Study Reports (CSRs), briefing book materials, and IND/NDA summary and submission documents.

• Develop documents aligned with regulatory requirements, internal standards, medical writing plans, and clinical development objectives.

• Integrate scientific and clinical information from Clinical Development, Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, Pharmacovigilance, and Medical Affairs functions.

• Manage document review cycles, incorporate reviewer comments, and coordinate deliverables against established medical writing timelines.

• Support regulatory submissions, health authority interactions, and inspection readiness activities.

• Contribute to medical writing templates, style guides, processes, and operational procedures.

Education

• Bachelor's degree or higher in a relevant scientific, medical, or related discipline.

• Advanced degree preferred.

Required Skills

• Hands-on medical writing experience within pharmaceutical, biotechnology, CRO, or clinical research environments.

• Experience authoring or reviewing Clinical Study Reports (CSRs), clinical study protocols, protocol amendments, and Investigator Brochures (IBs).

• Experience with IND/NDA summary documents and regulatory submission materials.

• Knowledge of clinical development processes and ICH guidelines.

• Working knowledge of Good Clinical Practice (GCP) and clinical/regulatory documentation requirements.

• Experience supporting global clinical development programs and regulatory documentation.

Preferred Skills

• Experience developing briefing book materials for regulatory interactions.

• Experience supporting health authority interactions and inspection readiness.

• Experience developing or maintaining medical writing templates, style guides, and standard operating procedures.

• Experience managing multiple clinical/regulatory document deliverables across development programs.

• By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy

#LI-BS1