Job Purpose: Were seeking an experienced Principal Investigator (PI) to lead BA/BE clinical trials at our site in Noida. The PI will ensure studies are conducted ethically, maintaining subject safety, data integrity, and full compliance with study protocols and regulatory guidelines. Key Responsibilities: Lead and supervise BA/BE studies per protocol, ICH-GCP, and regulatory standards. Conduct medical assessments, manage subject eligibility, and oversee adverse event reporting. Ensure informed consent is transparent, ethical, and patient-friendly. Provide immediate medical care during emergencies and ensure proper documentation. Ensure accurate data capture and completeness of source documents. Participate in site monitoring, audits, and inspections, addressing any findings promptly. Mentor and train clinical teams, fostering a culture of scientific rigor and compliance. Review and sign off on study-related documents (e.g., CRFs, source documents, medical reports). Contribute to clinical study reports and publications, as applicable. Qualifications & Experience: MBBS/MD (Pharmacology, Clinical Pharmacology, or relevant specialization). 3-4 years as a Principal Investigator or Sub-Investigator in BA/BE studies or early-phase trials. Strong knowledge of ICH-GCP and local/global regulatory frameworks. Proven track record in safeguarding subject safety and data integrity. Interested? Share your CV at HR@skylimitresearch.com or call 9971733709 Why Join Us? Be part of a dynamic and growing CRO committed to innovation, quality, and global excellence in clinical research.
Company Description Skylimit Research Private Limited provides a comprehensive range of clinical, preclinical, and bio/analytical services supporting innovator, biosimilar, and generic drug development programs globally. As an independent, investor-owned, and professionally managed contract research group, we offer scientific leadership, robust quality management systems, and long-term stability. We serve clients in the clinical research organisation Clinical trial management, Preclinical Research and Development, Regulatory support and submissions of study data, Bioanalytical services, Pharmacovigilance, Statistical Services. Role Description This is a full-time on-site role for a Medical Writer located in Noida. The Medical Writer will be responsible for preparing scientific documents, medical communications, and research articles. Daily tasks include conducting thorough research, writing, and editing various types of medical content, ensuring accuracy and compliance with regulatory standards. Collaboration with scientists and other team members to produce high-quality deliverables is also a key part of the role. Qualifications Scientific Writing, Medical Writing, and Writing skills Experience in Medical Communications Research skills Attention to detail and excellent organizational skills Strong written and verbal communication skills Ability to work collaboratively in an on-site team environment Understanding of regulatory standards in the pharmaceutical. Bachelor's degree in Life Sciences, Medicine, Pharmacy, or a related field.