Klin Health Bio Pvt Ltd aims to support innovator and generic drug development for global clients. According to its stated mission, it provides a comprehensive portfolio of services, including:Clinical researchBioanalytical servicesRegulatory supportThe company emphasizes its use of skilled professionals (scientists, researchers, clinicians, and statisticians) and state-of-the-art facilities to deliver high-quality data and results. It positions itself as a partner to pharmaceutical and biotechnology companies, accelerating the development and commercialization of healthcare products.
We are Hiring!!
Department: Medical Writing and Regulatory Department
Qualification: B.Pharm/M.Pharm/MSc
Experience: 1 to 3 years
Skills:
1. Candidate should have basic knowledge of medical writing.
2. Candidate should have excellent communication skills.
3. Ready for immediate joining.
Job Responsibilities:
1. Preparation and review of Feasibility Assessment Report as per sponsor and regulatory requirements.
2. Preparation and review of Protocol as per sponsor and regulatory requirements.
3. Preparation and review of Informed Consent Document (ICD) in English and vernacular language according to protocol.
4. Preparation of a Case Report Form (CRF) within the proposed timeline as per regulatory requirements.
5. Coordination with clinical, bioanalytical department, principal and co-investigators, and other respective departments while preparing Protocol, Feasibility Assessment Report, Informed Consent Document, and Case Report Form.
6. Interpretation of study outcome in coordination with Principal Investigator.
7. Coordination with Ethics Committee (EC) in submission of study-related documents and obtaining approval.
8. Preparation and review of in-house Standard Operating Procedure (SOP).
9. Ensure the submission of DCGI NOC documents to the office of DCGI for BA/BE studies for requisite approval on time.
10. Any other responsibility delegated by Head-Medical Writing.
Interested Candidates can share their CVs on: hr@klinhealthbio.com
