Job Description

Department Details

Role Summary

We are seeking a Medical Regulatory Writing spoc who has hands on experience across
1. Medical (Regulatory) Writing
2. Scientific Communications
3. Data analysis
4. Adobe Pro, MS Office, Endnote, SharePoint.

Key Responsibilities

1. Write, edit, review, format all regulatory (clinical and nonclinical) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO and ICH guidelines.
2. Write, edit, review, clinical publications (systematic reviews, meta-analysis, manuscripts-primary and secondary, abstracts, posters, slide deck etc.) from Clinical Development and Medical Affairs.
3. Interpret, represent and summarize clinical and scientific data.
4. Plan and track completion of clinical and nonclinical regulatory dossiers.
5. Organize and archive clinical documents and publications.
6. Provide medical review of promotional and non-promotional materials for each brand.
7. Conduct literature searches and interpret scientific literature for internal stakeholders, including competitor assessments.
8. Manage stakeholders across line functions and geographies: medical affairs, clinical development, patents, legal, key opinion leaders
9. Manage assigned individual projects and hold complete responsibility through the document lifecycle.
10. Ensure consistency at all times with compulsory and voluntary codes of conduct, appropriate legislations and compliance with internal SOPs.
11. Train peers from other departments in scientific and technical writing.
12. Mentoring and coaching of direct reportees.

Educational Qualifications

Required Education Qualification: B.pharma
Required Experience: 6 - 25 years

Biocon