Klin Health Bio Pvt Ltd is a dynamic organization committed to advancing the development of innovative and generic drugs for clients globally. With a mission to deliver high-quality data and results, the company offers a comprehensive suite of services including clinical research, bioanalytical services, and regulatory support. Their team, composed of skilled scientists, researchers, clinicians, and statisticians, utilizes state-of-the-art facilities to ensure the efficient commercialization of healthcare products, making Klin Health Bio a valuable partner in the pharmaceutical and biotechnology sectors.
We Are Hiring!
Klin Health Bio Pvt Ltd is excited to announce openings in our Medical Writing and Regulatory Department. We are looking for passionate and qualified individuals to join our team.
Position: Medical Writer
Department: Medical Writing and Regulatory Department
Qualifications and Expertise Required:
- Educational Background: Candidates must hold a B.Pharm, M.Pharm, or MSc degree.
- Experience Level: We are seeking individuals with 1 to 3 years of experience in related fields.
- Skill Set:
- Fundamental understanding of medical writing.
- Exceptional communication abilities, both verbal and written.
- Willingness to join immediately, facilitating a smooth transition and contribution to our team.
Key Responsibilities:
As a Medical Writer at Klin Health Bio, you will play an essential role in our operations. Your daily tasks will include the following:
- Preparation and Review of Feasibility Assessment Reports: Ensure these documents meet both sponsor and regulatory specifications.
- Protocol Development: Create and assess study protocols accurately aligned with sponsor objectives and regulatory guidelines.
- Informed Consent Document (ICD) Preparation: Draft and review informed consent forms in both English and local languages based on protocol requirements.
- Case Report Form (CRF) Preparation: Construct CRFs while adhering to the timeline and regulatory standards.
- Cross-Department Coordination: Collaborate with various departments including clinical, bioanalytical, and principal/co-investigators to streamline the development process of protocols, feasibility reports, informed consent documents, and CRFs.
- Study Outcome Interpretation: Work alongside the Principal Investigator to analyze study findings effectively.
- Ethics Committee Coordination: Engage with the Ethics Committee for timely submission of study-related documents and acquisition of necessary approvals.
- Standard Operating Procedures (SOP): Develop and review in-house SOPs to optimize workflows.
- Regulatory Submissions: Ensure timely submission of the Drug Controller General of India (DCGI) No Objection Certificate (NOC) for Bioavailability/Bioequivalence (BA/BE) studies.
- Additional Responsibilities: Undertake other tasks as assigned by the Head of Medical Writing, ensuring flexibility and a commitment to excellence.
Why Join Klin Health Bio Pvt Ltd?
At Klin Health Bio, we believe in fostering a collaborative and innovative work environment. By joining our team, you’ll become an integral part of a company that is not only dedicated to driving advancements in healthcare but also champions professional growth and development.
How to Apply:
If you are interested in becoming a part of our dedicated team and meet the qualifications outlined above, we invite you to share your CV with us at hr@klinhealthbio.com. We look forward to reviewing your application and potentially welcoming you aboard as we continue to make significant strides in the pharmaceutical industry.
Conclusion
Joining Klin Health Bio Pvt Ltd is more than just a job; it’s an opportunity to be part of a forward-thinking organization committed to enhancing health outcomes on a global scale. By bringing together talented professionals dedicated to excellence, we can accelerate the development and commercialization of vital healthcare products. Don’t miss your chance to contribute to this meaningful work—apply today!
