SIRO Medical Writing Hiring Regulatory Medical Writer

SIRO Medical Writing Regulatory Writer Jobs India

Life Sciences, Pharmacy professionals with 5+ yrs experience can apply for Regulatory Medical Writer role at SIRO Medical Writing Pvt Ltd.

SIRO Medical Writing Pvt. Ltd. has announced an exciting opportunity for experienced professionals in the Regulatory Medical Writing domain. The organization is currently hiring skilled candidates for the position of Regulatory Medical Writer, offering professionals the chance to contribute to global pharmaceutical and clinical research documentation.

Medical writing plays a critical role in the pharmaceutical and clinical research industry. Regulatory medical writers are responsible for preparing complex scientific and regulatory documents that support drug development, clinical trials, and regulatory approvals. These documents ensure that pharmaceutical products meet strict global standards before reaching patients.

SIRO Medical Writing Pvt. Ltd. is looking for professionals with 5+ years of experience in regulatory medical writing, particularly in drafting and reviewing regulatory documents such as Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), Informed Consent Documents (ICDs), narratives, tables of studies, and eCTD summaries.

Professionals working in regulatory medical writing play an important role in supporting global pharmaceutical companies by preparing accurate, compliant, and scientifically sound documentation required by regulatory authorities such as USFDA, EMA, MHRA, and other global health agencies.

For professionals seeking to advance their careers in clinical research documentation, regulatory submissions, and pharmaceutical regulatory writing, this role provides an opportunity to work in a highly specialized and globally recognized domain.

Company Overview

SIRO Medical Writing Pvt. Ltd. is part of the SIRO Clinpharm group, a well‑known clinical research organization (CRO) that provides integrated clinical research and regulatory services to global pharmaceutical, biotechnology, and medical device companies.

The organization specializes in providing high‑quality regulatory documentation and scientific writing support throughout the drug development lifecycle. SIRO supports pharmaceutical sponsors by developing regulatory documents required for clinical trial submissions, regulatory approvals, and marketing authorization applications.

The company’s services include:

• Regulatory medical writing
• Clinical study report preparation
• Clinical protocol development
• Regulatory submission documentation
• eCTD and dossier support
• Clinical research documentation review

SIRO Medical Writing teams work closely with clinical research professionals, regulatory affairs specialists, biostatisticians, and pharmaceutical scientists to ensure that documentation submitted to regulatory agencies meets strict scientific and compliance standards.

By maintaining adherence to international regulatory guidelines such as ICH guidelines, GCP standards, and global regulatory submission frameworks, SIRO ensures that documentation produced by its teams supports the safe and effective development of pharmaceutical products.

Professionals working at SIRO gain exposure to global pharmaceutical projects and advanced regulatory documentation systems used in international clinical trials.

Job Role & Responsibilities

The Regulatory Medical Writer role focuses on preparing and reviewing scientific and regulatory documents required for pharmaceutical clinical development and regulatory submissions.

Regulatory Document Preparation

Medical writers are responsible for developing regulatory documents used in clinical trials and regulatory submissions.

Key responsibilities include:

• Drafting Clinical Study Reports (CSRs)
• Preparing clinical trial protocols
• Writing Investigator Brochures (IBs)
• Developing Informed Consent Documents (ICDs)

These documents are critical for ensuring transparency and compliance in clinical research activities.

Regulatory Submission Support

Medical writers assist regulatory teams in preparing documentation required for global regulatory submissions.

Key responsibilities include:

• Preparing tables of studies and clinical summaries
• Supporting eCTD submission documentation
• Drafting regulatory summaries and reports
• Ensuring documentation meets regulatory submission standards

These activities ensure that regulatory agencies receive well‑structured scientific data supporting pharmaceutical product approvals.

Scientific Review and Quality Checks

Regulatory medical writers are responsible for reviewing documentation to ensure scientific accuracy and regulatory compliance.

Key responsibilities include:

• Reviewing clinical documents for consistency and accuracy
• Verifying data presented in study reports
• Ensuring compliance with regulatory guidelines
• Maintaining document version control and documentation integrity

These review activities help maintain the reliability and credibility of clinical research documentation.

Collaboration with Cross‑Functional Teams

Medical writing teams collaborate with several departments during document preparation.

Key responsibilities include:

• Coordinating with clinical research teams
• Working with biostatistics and data management teams
• Supporting regulatory affairs teams during submission preparation
• Addressing document review comments and revisions

Effective collaboration ensures that regulatory documentation accurately reflects clinical research findings.

Eligibility / Qualifications

SIRO Medical Writing Pvt. Ltd. is seeking experienced professionals with academic backgrounds in life sciences and pharmaceutical sciences.

Required Educational Qualifications

Relevant qualifications include:

B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences

Relevant academic disciplines include:

Pharmacy, Pharmacology, Clinical Research, Biotechnology, Microbiology, Biochemistry, Life Sciences

These educational backgrounds provide foundational knowledge in clinical research methodologies, pharmaceutical sciences, drug development processes, and regulatory documentation standards.

Experience Requirement

Candidates must have minimum 5+ years of experience in regulatory medical writing.

Relevant experience includes:

• Clinical study report writing
• Regulatory documentation drafting
• Clinical protocol preparation
• Regulatory submission documentation
• eCTD summary preparation

Professionals with experience working in clinical research organizations (CROs) or pharmaceutical regulatory documentation teams will be preferred.

Required Skills

Ideal candidates should possess:

• Strong scientific writing skills
• Understanding of clinical research documentation
• Knowledge of regulatory guidelines
• Ability to analyze clinical data
• Excellent attention to detail and documentation accuracy

Experience working with clinical research documentation systems and regulatory submission platforms will be an advantage.

Location & Salary

Job Location

SIRO Medical Writing Pvt. Ltd.

India (office location based on company assignment)

Medical writing professionals often work in major pharmaceutical hubs where clinical research and regulatory documentation teams collaborate with global pharmaceutical sponsors.

Salary

Salary packages are determined based on candidate experience, expertise, and company policies. Regulatory medical writing professionals typically receive competitive compensation packages due to the specialized nature of their work.

Application Process

Interested candidates who meet the eligibility criteria can apply by sending their updated resumes.

Send your CV to:

vedanshi.hemani@siroclinpharm.com

Applicants should include the following information when submitting their resume:

• Full name
• Educational qualifications
• Total experience in medical writing
• Experience in regulatory documentation
• Notice period availability

Shortlisted candidates will be contacted by the recruitment team for further discussions and interviews.

Why Build a Career in Regulatory Medical Writing

Regulatory medical writing is a highly specialized profession within the pharmaceutical and clinical research industries. Medical writers translate complex clinical and scientific data into structured regulatory documents used for drug development and regulatory approvals.

Professionals working in this field gain expertise in:

• Clinical research documentation
• Pharmaceutical regulatory guidelines
• Drug development processes
• Regulatory submission systems
• Scientific and regulatory writing techniques

Medical writing professionals play a vital role in the pharmaceutical industry by ensuring that regulatory authorities receive clear, accurate, and compliant documentation.

Career opportunities in regulatory medical writing include:

• Senior Medical Writer
• Regulatory Documentation Manager
• Clinical Research Documentation Specialist
• Regulatory Affairs Medical Writer

As pharmaceutical research continues to expand globally, the demand for experienced medical writers continues to grow across pharmaceutical companies, CROs, and biotechnology organizations.

Frequently Asked Questions (FAQs)

Who can apply for the SIRO Medical Writer role?

Professionals with life sciences or pharmacy qualifications and at least 5 years of regulatory medical writing experience can apply.

What documents should candidates have experience with?

Candidates should have experience drafting Clinical Study Reports, protocols, Investigator Brochures, Informed Consent Documents, and eCTD summaries.

What industry does this role belong to?

The role belongs to the pharmaceutical and clinical research industry.

How can candidates apply?

Candidates can send their updated resume to the official HR email mentioned in the job posting.

What skills are important for medical writing?

Strong scientific writing, understanding of regulatory guidelines, and experience with clinical documentation are essential skills.

Job Summary

Company	SIRO Medical Writing Pvt Ltd
Vacancies	Regulatory Medical Writer
Required Education	B.Pharm, M.Pharm, Pharm.D, M.Sc Life Sciences
Experience	5+ Years