Senior Medical Writer

Job Description

Recruise is looking for a Senior Medical Writer to join their Medical Writing function in Bengaluru. The  role is a full-time role where you will be focusing on the  clinical document authorship,  producing and owning high-quality regulatory and clinical documents, with this also  maintaining the standards that define the function's output. The role  is for someone who  works independently, drives their own assignments forward, and holds themselves accountable for data integrity and document quality. In this job having a strong background in regulatory medical writing and  readiness  to operate at a senior level without needing to be told what to do next.

Key Responsibilities

Clinical Document Authorship:

 In this role offers you lots of work in different domains  you will be expected to produce and own a range of clinical and regulatory documents also looking at the regulatory submissions, protocols, clinical study reports like the  NDA and MAA CTD documents,you will also have  investigator brochures, briefing documents, and responses to questions from regulatory authorities. There will be some assignments  where you will handle independently but  others  will involve a mentor, depending on how  complex the task is .

Data Integrity and Document Quality:

In this job you will be personally accountable for the accuracy and integrity of the data in your documents. In case of any  interpretive disagreements within the document team, you will  act as a negotiator  and ensure that every final document is perfect.With this you will also make sure that the quality and consistency, not only in your own documents but across the team's collective output is maintained.

Independent Work Management:

The assignments that you make should never compromise the quality,your own work needs to be driven forward by you.Also raising issues early is necessary and keeping the people aligned through planning meetings, coordination calls, and review sessions is expected from you.

Standard Advocacy:

 The standard advocacy steps are that whenever  you identify a flaw  in a document or in a process  you flag it, explain why it matters, and come up with an alternative solution.

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:

Manage two or three complex documents simultaneously without affecting the quality of any of them. You flag issues proactively, and do not wait to be directed.

Scientific Communication:

You can take complex clinical information and present it accurately and cohesively in a document that holds up to regulatory scrutiny in this process you always need to make sure that the document is clear and has  precise scientific writing and data interpretation

Interpersonal and Coordination Skills:

 You keep stakeholders aligned and raise disagreements constructively rather than letting them sit unresolved, with this you also maintain effective communication across document teams, review sessions, and planning meetings

Qualification Required

Education:

Life sciences degree ( Bachelors and Masters, Ph.D., or equivalent) from a recognised institution.

Experience:

Experience of  working independently on multiple concurrent regulatory documents  as well as having experience in regulatory medical writing with proficiency in CTD submissions is essential.

Benefits

Professional Environment:

Scientific Writing function at Recruise  values quality, standards, and professional rigour. The writers in the team are very professional , they always take ownership of their  work.

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  the CTD authorship, multi-document management, cross-functional coordination that you will  gain here is  valued across the pharmaceutical and medical writing industry globally.