Type : Full Time
Location : Bengaluru
Experience Required : 3 Year(s)
Industry : Pharma/Biotech/Clinical Research
Preferred Skills : Content Editor Content Writer Creative Writer
Job Description :
-Utilize regulatory expertise to review, develop and deliver core labeling documents such as the local product labels and Patient Leaflet to support submissions to the Regulatory Authorities across regions.
-Understands and applies labeling regulation in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text
-Has good understanding/ knowledge of principles and concepts of labeling-related disciplines.
-Well-versed with different country-specific process/formats (US labelling (SPL/XML), EU labelling etc)
-Well-versed with different databases used within the PV/regulatory labelling space.
-Accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations
-Ensure that clinical documents adhere to current global standards, FDA, ICH and GCP guidelines and are in accordance with electronic publishing standards.
-Review SOPs and other job aids for completeness as needed.
-Review and write proposals and project status reports
-Has thorough knowledge of the principles, concepts and theories of labeling, and awareness of principles and concepts of other labeling-related disciplines.
-Understands and applies labeling regulation knowledge in the region and in assigned local countries, and is able to interpret impact of that regulation on development of labeling text.
1 Minimum 2 to 3 years of experience in pharmaceutical companies in any of the following functionspharmacovigilance, regulatory-labeling
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.
Life science post-graduate with 2 to 3 years of experience in Pharmacovigilance, regulatory labeling, Safety/regulatory labeling Database and Technology