REV Clinical (formerly CBCC Global Research) is hiring a Medical Writer for a remote position. The opportunity is suitable for professionals with 3–6 years of medical writing experience in a clinical research organization (CRO), pharmaceutical company, or biotechnology environment. Candidates with experience in clinical study protocols, regulatory documentation, Module 2 summaries, clinical study reports, and scientific publications can apply.
Job Details
| Particulars | Details |
|---|---|
| Company | REV Clinical (formerly CBCC Global Research) |
| Job Title | Medical Writer |
| Job Location | Remote |
| Hiring Office | Ahmedabad, Gujarat |
| Experience | 3–6 years |
| Employment Type | Full-time, Permanent |
| Qualification | Degree in Life Sciences, Pharmacy, Medicine, or a related discipline |
| Preferred Qualification | Advanced degree |
| Industry | Clinical Research / Contract Research |
| Department | Healthcare & Life Sciences |
| Website | www.revclinical.com |
Position: Medical Writer
The Medical Writer will independently prepare, review, and finalize clinical and regulatory documents, including clinical study protocols, informed consent forms, investigator brochures, Module 2 summaries, regulatory submissions, and scientific publications.
The role involves collaboration with Project Management, Data Management, Biostatistics, Medical Monitoring, and Quality Assurance teams to ensure document accuracy, regulatory compliance, and timely delivery.
Key Responsibilities
- Prepare, review, and finalize medical writing documents, including concept sheets and clinical study protocols.
- Develop study-related documents such as Informed Consent Forms (ICFs), Case Report Forms (CRFs), and Investigator Brochures (IBs).
- Prepare clinical and non-clinical overviews and summaries for Module 2 regulatory documentation.
- Develop regulatory briefing documents, controlled correspondence, scientific advice documents, and applications for orphan drug designation, fast track designation, and accelerated approval.
- Review Clinical Study Reports (CSRs), Statistical Analysis Plans (SAPs), and study results.
- Prepare Subject Expert Committee (SEC) presentations in consultation with medical monitors and other stakeholders.
- Develop manuscripts, abstracts, scientific posters, and slide presentations for scientific meetings.
- Review study-specific project management plans in consultation with project managers.
- Coordinate with cross-functional teams to maintain document quality, regulatory compliance, and project timelines.
- Ensure compliance with quality management systems and documentation requirements.
- Guide and coordinate team members as required.
Eligibility and Qualifications
Candidates applying for the REV Clinical Medical Writer job should meet the following requirements:
- A degree in Life Sciences, Pharmacy, Medicine, or a related discipline.
- An advanced degree is preferred.
- 3–6 years of medical writing experience in a CRO, pharmaceutical, or biotechnology environment.
- Demonstrated experience in authoring clinical study protocols, ICFs, IBs, and concept sheets.
- Experience preparing Module 2 clinical and non-clinical overviews and summaries.
- Exposure to regulatory briefing documents, scientific advice, orphan drug applications, and fast track applications.
- Experience reviewing CSRs, SAPs, and clinical study results.
- Working knowledge of ICH-GCP and applicable FDA, EMA, and CDSCO guidelines.
- Experience preparing scientific manuscripts, abstracts, and presentations is an advantage.
Required Skills
- Medical writing and scientific communication
- Clinical study protocol writing and design
- Clinical trial documentation
- Regulatory writing and CTD documentation
- Clinical Study Report review
- ICH-GCP and regulatory guidelines
- Oncology-related clinical research documentation
- Attention to detail and quality management
- Cross-functional communication and stakeholder coordination
- Project timeline and document management
- Ability to work independently in a remote environment