Job opportunity in Scientific Writing at Indegene- Apply before 25th September 2024

Lead – Scientific Writing

Join Us in Shaping the Future of Healthcare

About Indegene

At our company, we empower biopharmaceutical, emerging biotech, and medical device companies to develop innovative products, bring them to market, and grow their impact throughout the product lifecycle. We leverage our deep healthcare domain expertise, cutting-edge technology, and agile operating model to deliver personalized, scalable, and omnichannel experiences for patients and physicians. Our mission is to ensure that healthcare organizations are equipped to meet the challenges of the future.

Position: Lead – Scientific Writing

Role Purpose: As the Lead – Scientific Writing, you will manage a team, oversee the development and review of various regulatory deliverables and dossiers, and ensure that all outputs meet high-quality standards as per Health Authority (HA) requirements.

Key Responsibilities:

• Regulatory Knowledge: Demonstrate a thorough understanding of regulatory affairs procedures and country-specific requirements for the EU, MENA, and ASEAN markets, including initial submissions, licensing, and post-approval submission management.
• Project Management: Apply strong project management, organizational, and time management skills to oversee client-specific project delivery processes.
• Analytical Skills: Utilize robust analytical and problem-solving abilities to address complex regulatory challenges.
• Guidance and Collaboration: Provide strategic guidance to project teams on worldwide HA submission structures, formats, and requirements, ensuring compliance with eCTD, ACTD, and non-eCTD formats for submissions like NDA/BLA/INDs, MAAs.
• Cross-Functional Coordination: Collaborate with cross-functional groups, including Regulatory Affairs, CMC, Submission Managers, and Medical Writing teams, to gather accurate information for regulatory submissions.
• Submission Management: Develop and maintain submission delivery plans and proactively update collaborators on the status of submissions. Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications.
• Content Review: Oversee the preparation and review of regulatory dossiers, ensuring compliance with all relevant guidelines. Conduct gap analyses to identify compliance issues and implement corrective actions.
• Quality Control: Perform quality checks on content prepared by junior team members to ensure authenticity and accuracy. Lead root cause analyses (RCA) and prepare corrective and preventive action plans (CAPA) as needed.
• Inspection Preparation: Prepare the company for regulatory inspections and audits by conducting mock audits and readiness assessments.
• Client Engagement: Regularly engage with clients through calls to discuss content and project status updates. Participate in client-specific training when applicable.
• Mentorship: Mentor new team members on standard operating procedures (SOPs) and processes, helping them understand different target audiences and approaches to various deliverables.

Candidate Profile:

• Education: BPharm / MPharm / Pharm D / MSc
• Experience: 6-8 years of experience in regulatory affairs for the EU, MENA, and ASEAN markets.
• Skills:
  • Proficient in Dossier Preparation (eCTD, ACTD, and CTD formats).
  • Excellent written and oral communication skills.
  • Strong proficiency in MS Office (Excel and PowerPoint) and Adobe Professional.
  • Hands-on experience with Regulatory Information Management Systems (RIMS) like Veeva Vault and Trackwise is desirable.

Additional Information:

• Qualification: BPharm, MPharm, Pharm.D, MSc
• Experience: 6-8 years
• Location: Bangalore, KA
• Industry Type: Pharma/Healthcare/Clinical Research
• Functional Area: Scientific Writing
• Application Deadline: 25th September 2024

Be a part of a team that is passionate about transforming healthcare and making a difference in the lives of patients and healthcare professionals worldwide.