Indegene is an integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, training, and research &amp;amp;amp; analytics services. With operations across the US, Europe and the Emerging Markets, track record of working with most of the Top 20 global pharmaceutical companies.
Job Title – Regulatory Writing/ Medical Writing
Location – Bangalore/Bengaluru
Experience – 3 – 7 Years
UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
Knowledge and Skills Required:
1. Minimum 2 to 4 years of experience in pharmaceutical companies in any of the following functions- regulatory/medical writing- PBRER.
2. Understanding of any specialty area of medicine (preferred) or an overall understanding of the medical field.
3. Strong flair and passion for writing.
4. Strong written and verbal communication/presentation skills.
5. Passion for networking.
6. Being up-to-date with the latest technical/scientific developments and relating them to various projects.
Job Description –
1.Responsible for authoring regulatory/ safety documents such as Protocol, CSR,PBRER/PSUR, Subject Narratives, Aggregate Reports, RMPs and others
2.Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
3.Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards. Update SOPs and other job aids for completeness as needed.