Senior Medical Writer & Project Lead – Flexible Hours

Quanticate; United States; Remote; USD 90,000 - 130,000; Full time

Benefits offered by this job

Competitive salary

Flexible working hours

Holidays and leave

Medical Insurance for self and family

Gratuity

Accidental Coverage

Learning development opportunities

Job summary

Quanticate is seeking a Medical Writer (Consultant) to lead and contribute to regulatory and scientific documents across clinical development programmes worldwide.

You will collaborate with cross-functional teams, provide subject-matter guidance, and support continuous improvement in medical writing processes. The role emphasizes mentorship and client interaction within a data-focused CRO environment.

Qualifications

• Master’s degree in Life Sciences, Medical Sciences, Pharmacy, or related field.
• A PhD, PharmD, MD, MVSc, or equivalent advanced qualification is desirable.

Responsibilities

• Author, review, and quality-check regulatory and scientific documents (clinical study reports, etc.).
• Ensure documents reflect source data, meet regulatory requirements, and comply with standards.
• Manage document review cycles and coordinate feedback from multiple stakeholders.
• Provide editorial support, proofreading, and quality control reviews.
• Support document publishing activities and submission-ready deliverables.
• Manage multiple writing projects within timelines and budgets.
• Track milestones, risks, and progress using PM tools.
• Collaborate with project teams, reviewers, and subject matter experts.
• Maintain accurate project records, including time reporting and metrics.
• Serve as client point of contact and build strong relationships.
• Support proposal development and business development activities.
• Provide training and mentorship to junior writers.

Skills

Written communication

Verbal communication

Complex concept translation

Attention to detail

Organization & prioritisation

Analytical thinking

Independent working

Stakeholder management

MS Office proficiency

Continuous learning

Education

Master’s degree in Life Sciences or related field

PhD/MD/PharmD or equivalent (desirable)

Tools

Microsoft Office

Document management systems

Job description

Quanticate is seeking a Medical Writer (Consultant) to lead and contribute to regulatory and scientific documents across clinical development programmes worldwide.

You will collaborate with cross-functional teams, provide subject-matter guidance, and support continuous improvement in medical writing processes. The role emphasizes mentorship and client interaction within a data-focused CRO environment.