Remote Principal Medical Writer – Clinical Regulatory Expert

Synchrogenix Information Strategies, LLC; Massachusetts; On-site; USD 142,000 - 153,000; Full time

Benefits offered by this job

Remote working

Flexible time off

Medical insurance

Tuition reimbursement

Retirement plans

Paid holidays

Job summary

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications for all stages of product development. You will organize, analyze, interpret, and present scientific data in line with ICH guidelines and company standards.

Collaborating with cross-functional teams under Medical Writing management, you will contribute to high-quality submissions and strategic regulatory communications for global programs, while maintaining a focus on

Qualifications

• Bachelor’s degree in a science-related field is required; science background preferred.
• Minimum of 7 years of medical writing experience in CRO/pharma setting.
• Advanced knowledge of ICH and related regulatory guidelines.
• Excellent written English with strong attention to detail.
• Strong interpersonal and communication skills; able to collaborate cross-functionally.
• Experience with Microsoft Office Suite is essential, including advanced features.

Responsibilities

• Plan and prepare regulatory documents and medical communications for all development phases.
• Organize, analyze, interpret, and present scientific data per ICH guidelines and company standards.
• Collaborate with cross-functional internal and external document production teams under Medical Writing management.

Skills

Medical writing

ICH guidelines

Excellent written English

Interpersonal & communication skills

Education

Bachelor’s degree in science-related field

7+ years medical writing experience

Tools

Microsoft Office Suite

Job description

Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications for all stages of product development. You will organize, analyze, interpret, and present scientific data in line with ICH guidelines and company standards.

Collaborating with cross-functional teams under Medical Writing management, you will contribute to high-quality submissions and strategic regulatory communications for global programs, while maintaining a focus on