Amaris Clinical, a division of Caplin Point Laboratories, is inviting applications for the position of Clinical Medical Writer. This opportunity is ideal for candidates with 2–3 years of experience in clinical research, medical writing, clinical trial documentation, and regulatory submissions. Candidates holding B.Pharm, M.Pharm, or Pharm.D qualifications can apply for this exciting role.
Medical writing professionals seeking careers in clinical trial protocol writing, clinical study report preparation, regulatory documentation, and ethics committee coordination will find this opportunity highly rewarding. The organization is looking for talented individuals who can contribute to clinical research projects while ensuring compliance with ICH-GCP and regulatory requirements.
Job Overview
| Particulars | Details |
|---|---|
| Company Name | Amaris Clinical |
| Division | Caplin Point Laboratories |
| Position | Clinical Medical Writer |
| Number of Vacancies | 02 |
| Experience | 2–3 Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D |
| Department | Clinical Medical Writing |
| Employment Type | Full-Time |
| Application Mode | |
| Email ID | hr@amarisclinical.com |
Key Responsibilities
Selected candidates will be responsible for:
- Preparation of Clinical Study Protocols for BA/BE studies and clinical trials.
- Drafting and reviewing Informed Consent Documents (ICD).
- Writing and reviewing Clinical Study Reports (CSR) as per ICH-GCP guidelines.
- Preparing regulatory submission documents for BENOC and Test License applications.
- Coordinating Ethics Committee submissions and approvals.
- Supporting Ethics Committee meetings and documentation activities.
- Designing and preparing Case Report Forms (CRF) for clinical studies.
- Collaborating with investigators, clinical operations teams, and study personnel.
- Maintaining accurate clinical trial documentation.
- Ensuring compliance with GCP, regulatory guidelines, and study protocols.
Required Qualifications
Candidates must possess:
- B.Pharm, M.Pharm, or Pharm.D degree.
- 2–3 years of experience in Clinical Medical Writing.
- Experience in Clinical Study Protocol and CSR preparation.
- Knowledge of Bioavailability/Bioequivalence (BA/BE) studies.
- Understanding of regulatory submission processes.
- Strong documentation and technical writing skills.
- Good communication and coordination abilities.
- Thorough knowledge of ICH-GCP guidelines and clinical research regulations.
Desired Skills
- Clinical protocol writing expertise.
- Clinical Study Report (CSR) preparation.
- Regulatory documentation management.
- Ethics Committee coordination.
- Case Report Form (CRF) design.
- Attention to detail and data accuracy.
- Team collaboration and project coordination skills.
Why Join Amaris Clinical?
- Opportunity to work on diverse clinical research projects.
- Exposure to regulatory and ethics committee processes.
- Career growth in clinical research and medical writing.
- Professional work environment under Caplin Point Laboratories.
- Hands-on experience in BA/BE studies and clinical trials.
- Learning opportunities in regulatory compliance and documentation.
How to Apply
Interested and eligible candidates can share their updated CV to:
Email: hr@amarisclinical.com
