SIRO is hiring an experienced Senior Regulatory Medical Writer for its regulatory medical writing team. Candidates with at least 4 years of relevant experience in authoring and quality checking regulatory documents are encouraged to apply.
The role requires expertise in clinical and regulatory writing, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical trial protocols.
Applicants must have experience across 2–4 phases of clinical trials. Bioavailability/Bioequivalence (BA/BE) experience will not be considered for this opportunity.
The position offers hybrid working in Mumbai or remote working for candidates based outside the city, with preference for immediate joiners and candidates serving short notice periods.
SIRO Senior Regulatory Medical Writer Recruitment
Company Overview
SIRO is inviting applications from experienced professionals for the position of Senior Regulatory Medical Writer. This opportunity is suitable for candidates with a strong background in regulatory documentation, clinical research writing, document authoring, and quality control.
Job Details
- Company: SIRO
- Department: Regulatory Medical Writing
- Designation: Senior Regulatory Medical Writer
- Experience: Minimum 4 years
- Location: Mumbai, Maharashtra, or remote for candidates based outside Mumbai
- Work Mode: Hybrid or remote, depending on location
- Joining Preference: Immediate joiners or candidates with a short notice period
SIRO Senior Regulatory Medical Writer Job Role & Responsibilities
The recruitment announcement highlights regulatory document authoring, quality checking, and clinical trial experience as the main requirements for this position.
Key Responsibilities
- Author regulatory documents, including Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical trial protocols.
- Perform quality control (QC) of regulatory medical writing documents.
- Review clinical and regulatory documentation for accuracy and quality.
- Apply knowledge of clinical research and regulatory documentation requirements.
- Support the preparation and review of documents associated with clinical trials.
Eligibility & Qualifications
Educational Qualifications
The recruitment announcement does not specify a mandatory educational qualification. Candidates should confirm the academic eligibility criteria with the recruitment team.
Experience Requirements
- Minimum 4 years of relevant experience in regulatory medical writing.
- Experience in authoring and quality checking regulatory documents.
- Clinical trial experience across 2–4 phases is mandatory.
- Bioavailability/Bioequivalence (BA/BE) experience will not be considered for this position.
Required Skills
Candidates should have:
- Strong regulatory medical writing skills.
- Experience preparing and reviewing CSRs, IBs, and clinical trial protocols.
- Knowledge of clinical research and regulatory documentation.
- Strong document review and quality-checking abilities.
- Excellent written communication skills.
- Attention to detail and the ability to maintain documentation quality.
Location & Work Mode
SIRO is considering candidates for the following work arrangements:
Candidates should clarify the applicable work arrangement with the recruitment team during the application process.
Salary & Benefits
The salary package and additional employment benefits have not been specified in the recruitment announcement. Candidates can contact the recruitment team for further details.
How to Apply
Interested candidates who meet the experience and clinical trial requirements can apply by emailing their updated CV to the recruitment contact below.
Application Email: vedanshi.hemani@siroclinpharm.com
Application Instructions
- Send an updated CV highlighting relevant regulatory medical writing experience.
- Include experience in authoring and QC of regulatory documents.
- Clearly mention clinical trial experience across the applicable trial phases.
- Mention your current notice period and earliest possible joining date.
- Confirm your preferred work arrangement, whether hybrid in Mumbai or remote from outside Mumbai.
Joining Preference
Immediate joiners and candidates with short notice periods are preferred.
Documents Required
Candidates should keep the following documents ready:
- Updated resume or CV.
- Educational qualification certificates.
- Relevant work experience certificates.
- Supporting details of regulatory document authoring and QC experience.
- Details of clinical trial experience across different phases.
Frequently Asked Questions
1. What is the designation offered by SIRO?
SIRO is hiring for the Senior Regulatory Medical Writer position.
2. How much experience is required?
Candidates must have a minimum of 4 years of relevant regulatory medical writing experience.
3. Is clinical trial experience mandatory?
Yes. Experience across 2–4 phases of clinical trials is mandatory.
4. Are candidates with BA/BE experience eligible?
No. The recruitment announcement specifically states that BA/BE experience will not be considered.
5. Is remote work available?
Yes. Remote working is available for candidates based outside Mumbai. Hybrid working is offered for the Mumbai location.
6. How can candidates apply for this position?
Candidates can email their updated CV to vedanshi.hemani@siroclinpharm.com.
Job Summary
| Category | Details |
|---|---|
| Company | SIRO |
| Vacancies | Senior Regulatory Medical Writer |
| Required Education | Not specified in the recruitment announcement |
| Experience | Minimum 4 years; clinical trial experience across 2–4 phases is mandatory |