Senior Medical Writer

Job Description

Recruise is looking for a Senior Medical Writer to join their Medical Writing function in Bengaluru. This is a permanent, full-time role focused on clinical document authorship  producing and owning high-quality regulatory and clinical documents while maintaining the standards that define the function's output. The role demands someone who works independently, drives their own assignments forward, and holds themselves accountable for data integrity and document quality. If you have a strong background in regulatory medical writing and are ready to operate at a senior level without needing to be told what to do next, this role is worth your attention.

Key Responsibilities

Clinical Document Authorship:

Your primary function is producing and owning a range of clinical and regulatory documents  including regulatory submissions, protocols, clinical study reports, NDA and MAA CTD documents, investigator brochures, briefing documents, and responses to questions from regulatory authorities. Some assignments you will handle independently; others will involve working with a mentor, depending on complexity.

Data Integrity and Document Quality:

You are personally accountable for the accuracy and integrity of the data in your documents. When interpretive disagreements arise within the document team, you negotiate through them and ensure that every final document is defensible. You maintain quality and consistency not only in your own documents but across the team's collective output.

Independent Work Management:

You manage two or three concurrent assignments without compromising quality on any of them. You drive your own work forward, raise issues early rather than sitting on them, and keep the people around you informed and aligned through planning meetings, coordination calls, and review sessions.

Standards Advocacy:

At this level, doing good work quietly is not enough. When you identify a flaw  in a document or in a process  you flag it, explain why it matters, and come with an alternative. Actively advocating for high standards is part of the job description.

Skills Required

Regulatory Medical Writing:

Strong background in regulatory medical writing with hands-on experience across CTD submissions (NDA, MAA). You understand what makes a regulatory document defensible and you produce work at that standard.

Multi-Document Management:

Ability to manage two or three complex documents simultaneously without dropping quality on any of them. You plan your own workload, flag issues proactively, and do not wait to be directed.

Scientific Communication:

Clear, precise scientific writing and data interpretation. You can take complex clinical information and present it accurately and cohesively in a document that holds up to regulatory scrutiny.

Interpersonal and Coordination Skills:

Effective communication across document teams, review sessions, and planning meetings. You keep stakeholders aligned and raise disagreements constructively rather than letting them sit unresolved.

Qualification Required

Education:

Life sciences degree (B.Science,M.Science, Ph.D., or equivalent) from a recognised institution.

Experience:

Demonstrated experience in regulatory medical writing with proficiency in CTD submissions. Experience working independently on multiple concurrent regulatory documents is essential.

Registration:

Relevant professional registrations or certifications in medical writing (e.g., AMWA, EMWA) are an advantage but not mandatory.

Benefits

Professional Environment:

You will work within a structured Scientific Writing function at Recruise that values quality, standards, and professional rigour. The team is built around people who take ownership of their work and hold themselves to a high standard and an environment where strong writers thrive.

Career Advancement:

The Senior Medical Writer role at Recruise is a platform for growth into Principal-level responsibilities and beyond. The skills and regulatory expertise you build here  CTD authorship, multi-document management, cross-functional coordination  are valued across the pharmaceutical and medical writing industry globally.

Compensation:

Competitive compensation package commensurate with experience and expertise.