Join Our Medical Writing Team
Are you a dedicated professional with a passion for scientific communication and clinical research? A leading pharmaceutical organization, Quantys, is actively seeking a talented Medical Writer to join its growing team. This is an exciting opportunity to contribute to the development of high-quality clinical and regulatory documentation that supports innovative healthcare solutions and patient well-being.
We are looking for an individual with 3-5 years of experience in the Medical Writing department. Candidates should hold a qualification such as M.Pharm, Pharm.D, or M.Sc. in Life Sciences. This full-time position is based at our Kandla facility.
Key Responsibilities for this role include:
- Preparing and meticulously reviewing a wide range of clinical and regulatory documents. This includes Protocols, Investigator Brochures (IB), Informed Consent Forms (ICF), Patient Information Sheets (PIS), Clinical Study Reports (CSR), and Case Report Forms (CRF).
- Developing comprehensive documentation specifically for CDSCO/SUGAM and Ethics Committee submissions, ensuring all requirements are met.
- Conducting thorough scientific literature reviews to support and enhance the development of clinical documents.
- Ensuring strict compliance with established industry standards and guidelines, including ICH-GCP, NDCTR 2019, CDSCO guidelines, and the company’s Standard Operating Procedures (SOPs).
- Collaborating effectively with various internal and external stakeholders, such as Clinical Operations, Regulatory Affairs, Biostatistics, Data Management, and Sponsors, to achieve project objectives.
- Providing crucial support during regulatory inspections, sponsor audits, and internal quality assurance activities to maintain high standards.
What We Are Looking For:
The ideal candidate will possess exceptional scientific writing, editing, and literature review skills, coupled with strong communication abilities. Proficiency in essential office software, including Microsoft Word, Excel, and PowerPoint, is also required.
If you are eager to advance your career in Medical Writing within a dynamic pharmaceutical environment, we encourage you to apply. This role offers a significant opportunity to make a tangible impact on the advancement of healthcare.
To apply for this position, please send your resume and cover letter to kasturi.singh@rusanpharma.com.
