Indegene is an integrated scientific partner to global pharmaceutical and life sciences companies delivering a spectrum of marketing, medical, training, and research & 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
Qualifications –
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
