Scientific Writing_Aggregate reporting Recruise India Consulting

3.0 - 8.0 years

7 - 12 Lacs

Hyderabad, Bengaluru, Mumbai (All Areas)

Hybrid

Level A4 – 3+ years Associate - Scientific Writing_Aggregate reporting Locations – across any nodal offices/Hybrid **Job Description:** **Responsibilities:** - Responsible for the entire document life cycle, maintaining quality, timeliness, and compliance with internal/client SOPs and regulations. - End-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, PSURs, SUSAR, PADERs/PAERs, ACOs, RMPs , and ad-hoc regulatory and safety reports. - Perform QC review of documents to validate accuracy and relevance, ensuring compliance with client-specific style and global standards. - Assist and mentor junior writers, provide guidance, and ensure consistency and completeness of reports. - Continuous process improvement in the team for developing content. - Participate in assigned training programs and create training materials and guidelines. - Interface with clients regularly to meet their expectations. **Qualifications:** - Medical/M.Pharm/Pharm D/life sciences degree. - Minimum 4 years of experience in medical writing or equivalent life sciences domain experience. - Knowledge of regulatory documentation, drug development process, and global regulations. - Excellent written and verbal communication skills, organizational and time management skills, and strong data interpretation and presentation skills. - Strong interpersonal skills and the ability to be flexible in varying environments. Indegene is proud to be an Equal Employment Employer committed to Inclusion and Diversity. We do not discriminate based on race, religion, sex, color, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions will be based on business requirements, the candidate’s merit, and qualifications. We are an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to any protected characteristics. Thank you for your attention to this matter. We look forward to receiving suitable profiles from you soon.

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