SIRO Senior Regulatory Medical Writer

SIRO Recruitment – Senior Regulatory Medical Writer

SIRO is hiring a Senior Regulatory Medical Writer for candidates with at least 4 years of relevant experience in regulatory medical writing. This opportunity is suitable for professionals experienced in authoring and quality checking clinical and regulatory documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical trial protocols. Candidates must have experience across Phase 2–4 clinical trials; Bioavailability/Bioequivalence (BA/BE) experience alone will not meet the stated requirement. The position offers hybrid working in Mumbai or remote working for candidates based outside the location.

Company Overview

SIRO is seeking experienced regulatory medical writing professionals to support clinical and regulatory documentation activities. The role emphasizes scientific writing, document review, quality control, and clinical trial experience.

Job Details

Job Role & Responsibilities

The Senior Regulatory Medical Writer will contribute to the preparation and quality review of clinical and regulatory documents.

Key responsibilities based on the recruitment announcement include:

• Author regulatory documents such as Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical trial protocols.

• Perform quality control (QC) and review of regulatory medical writing documents.

• Ensure the accuracy, clarity, and quality of clinical and regulatory documentation.

• Apply knowledge of clinical research and clinical trial processes while preparing and reviewing documents.

Eligibility & Qualifications

Candidates should have relevant experience in regulatory medical writing and clinical research documentation.

Required experience and skills:

• Minimum 4+ years of relevant experience in regulatory medical writing.

• Experience in authoring and quality checking regulatory documents, including CSRs, IBs, and protocols.

• Mandatory experience across Phase 2–4 clinical trials.

• Strong understanding of clinical research and regulatory documentation.

• Excellent scientific writing, reviewing, and quality-checking skills.

Important: Bioavailability/Bioequivalence (BA/BE) experience will not be considered for this requirement.

Work Location & Schedule

• Mumbai candidates: Hybrid working arrangement.

• Outstation candidates: Remote working option.

• Joining preference: Immediate joiners and candidates serving a short notice period.

How to Apply

Interested candidates can share their updated CV directly with the recruitment contact.

• Email: vedanshi.hemani@siroclinpharm.com

• Email subject: Application for Senior Regulatory Medical Writer

Candidates should highlight their regulatory medical writing experience, document authoring and QC expertise, and Phase 2–4 clinical trial experience in their CV.

Job Summary