Lead - Scientific Writing

6-8 years

Preffered by Company

Bangalore

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Join Us at Indegene: A Technology-Led Healthcare Solutions Provider

At Indegene, we are at the cutting edge of healthcare and technology. Our mission is to empower healthcare organizations to be future-ready. We offer a unique career experience that blends innovation, collaboration, and entrepreneurial spirit. If you are driven, bold, and ready for global growth opportunities, we invite you to explore a career with us.

Why Indegene?

Dynamic Career Growth: We provide a platform for rapid career advancement with the stability and reliability you seek.
Leadership Development: We are committed to nurturing future leaders by mentoring and developing them into successful people managers and account managers.
Global Opportunities: Work at the intersection of healthcare and technology, and benefit from our global reach and fast-track career paths.
Purpose-Driven Work: Join a team that is passionate about making a difference and driven by purpose.

Excited? Here’s What We’re Looking For:

Role: Regulatory Affairs Manager

Location: [Specify Location]

Role Purpose: Lead a team in managing, developing, and reviewing regulatory deliverables and dossiers to ensure they meet Health Authority (HA) standards.

Key Responsibilities:

Dossier Preparation: Oversee the preparation of regulatory dossiers (eCTD, ACTD, CTD) and ensure quality and compliance with HA standards.
Regulatory Knowledge: Apply thorough knowledge of EU, MENA, and ASEAN market requirements for initial and post-approval submissions.
Project Management: Develop and maintain submission plans, and provide proactive status updates. Manage client-specific project delivery processes.
Cross-Functional Coordination: Work with Regulatory Affairs, CMC, Submission Managers, and Medical Writing teams to gather accurate information for submissions.
Content Review: Review and validate the content prepared by junior team members, and ensure high client satisfaction through quality and timely delivery.
Compliance and Quality: Conduct gap analyses, implement corrective actions, and prepare for regulatory inspections and audits.
Client Interaction: Regularly update clients on project status and content-related discussions. Mentor new team members and participate in relevant training.

Required Skills and Experience:

Education: Bachelor’s or Master’s degree in Pharmacy (BPharm, MPharm), Pharm D, or MSc.
Experience: 6-8 years of experience in regulatory affairs, specifically within EU, MENA, and ASEAN markets.
Technical Skills: Proficient in MS Office (Excel, PowerPoint), Adobe Professional, and experience with RIMS (Veeva Vault, Trackwise) preferred.
Regulatory Expertise: Strong understanding of regulatory guidelines related to dossier preparation and submission, including NDA/BLA/INDs, MAAs.

Equal Opportunity Employer:

Indegene is committed to fostering a culture of 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 are based on business needs, qualifications, and merit.

Ready to Join Us?

If you are eager to take on an exciting role in a rapidly growing organization with a strong purpose, apply today at www.careers.indegene.com.

Indegene: Where Healthcare Meets Innovation.

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Lead - Scientific Writing

Job Description

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