Vimta Labs Ltd, based in Hyderabad, Telangana, is a premier clinical research organization known for its excellence in offering a range of testing and research services in the fields of clinical diagnostics, drug development, and analytical services. With a focus on innovation and regulatory compliance, Vimta Labs has established itself as a trusted partner in clinical research, catering to both domestic and global clients.
Responsibilities in the Job
As a Medical Writer at Vimta Labs Ltd, you will be engaged in various critical tasks, including:
- Protocol Design: Developing clinical trial protocols, particularly for biosimilars and PK/PD (pharmacokinetic/pharmacodynamic) study designs.
- ICF Preparation: Crafting Informed Consent Forms (ICF) to ensure participant comprehension and regulatory compliance.
- CRF/eCRF Review: Reviewing Case Report Forms (CRF) and electronic CRFs for accuracy and completeness.
- Study Report Writing: Composing detailed study reports and other documents as per regulatory and clinical standards.
- Collaboration with Statisticians: Working closely with statisticians for data analysis and the review of study results.
- Regulatory Submissions: Preparing documents in line with eCTD (Electronic Common Technical Document) requirements to facilitate submissions.
- Handling Queries: Responding to sponsor, regulatory, and ethics committee queries with thorough, evidence-based information.
Qualifications
- Experience Required: A professional experience range of 2 to 6 years in clinical and regulatory medical writing.
- Educational Background: Relevant qualifications in the life sciences, clinical research, or similar fields are preferred.
- Skills Needed:
- Proficiency in regulatory writing and designing clinical trial protocols.
- Experience with eCTD submissions and study report writing.
- Ability to prepare comprehensive ICFs and review CRF/eCRF documents.
- Strong analytical skills and the ability to collaborate with cross-functional teams.
Key Skills for the Role
- Regulatory Writing: Competency in developing comprehensive and compliant regulatory documents.
- Protocol Design: Expertise in creating structured, thorough protocols for clinical trials.
- Report Writing: Ability to draft high-quality clinical study reports.
- ICF Preparation: Skills in creating participant-friendly informed consent forms.
- CRF Review: Attention to detail in the evaluation of case report forms.
- Data Analysis Collaboration: Aptitude for working with statisticians and interpreting data effectively.
- eCTD Knowledge: Familiarity with the electronic format required for regulatory submissions.
How to Apply
Interested candidates who meet the qualifications and have the required skill set are encouraged to apply for this on-site, full-time position at Vimta Labs Ltd. You can send your resume to keerthana.rojanala@vimta.com. The company offers a competitive salary package, estimated at ₹300K/yr to ₹700K/yr, and benefits that align with industry standards.
