Indegene looking for Scientific Writing Lead - M.Pharm, B.Pharm, MSc Apply

We help biopharmaceutical, emerging biotech and medical device companies develop products, get them to the market, and grow their impact through the life cycle in a more effective, efficient, and modern way. We bring together healthcare domain expertise, fit-for-purpose technology, and an agile operating model to provide a diverse range of solutions. These aim to deliver, amongst other outcomes, a personalized, scalable and omnichannel experience for patients and physicians. It’s what drives our team and our purpose to enable healthcare organizations to be future ready.

Post : Lead - Scientific Writing

Job Description
Role Purpose : Manage a team; direct, develop and review various regulatory deliverables & dossiers; ensure quality as per set HA standards.

Principal Responsibilities :
• Thorough knowledge of EU, MENA and ASEAN markets country requirements/regulatory affairs procedures for initial submission, licensing, post-approval submission management
• Solid project management, organizational and time management skills to manage
• Client-specific project delivery process
• Strong analytical skills and problem-solving skills
• Excellent knowledge on various regulatory guidelines related to Dossier Preparation & Regulatory Submission for EU, MENA and ASEAN markets in ACTD, eCTD and non-eCTD format [e.g., NDA/BLA/INDs, MAAs]
• Provides guidance to project teams related to worldwide HA submission structure/format/requirements, submission filing strategy, eCTD document lifecycle management and submission compilation workflows
• Co-ordinate with relevant cross functional group Regulatory Affairs, CMC, Submission Managers and Medical Writing to obtain accurate, appropriate information for regulatory submission
• Develops, completes, and maintains submission delivery plans, submission content plans, and proactively provides status updates to designated collaborators.
• Assist in the preparation and submission of post-approval regulatory filings, variations, and renewal applications
• Review regulatory dossier preparation and submission like new drug application, variations, renewals, site registration etc.
• Conduct gap analysis to identify compliance issues and implement corrective actions to align with regulatory requirements.
• Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared
• Responsible for high client satisfaction for all regulatory submission deliverables with regard to quality and accuracy, timelines, and efforts
• Performing RCA when required with the team and preparing CAPA
• Prepare the company for regulatory inspections and audits, including mock audits and readiness assessments.
• Conducting regular client calls for content-related discussions as well as for project status updates and delivery
• Participate in trainings and learn through hands-on experience on the job
• Participate in client-specific training if applicable
• Mentoring of new joiners with respect to SOPs and processes
• Understand various target audience and methods to approach different deliverables

Candidate Profile
EDUCATION : BPharm / MPharm/ Pharm D/ MSc
EXPERIENCE : Required 6-8 years of experience in EU, MENA and ASEAN markets
Skills :
• Dossier Preparation (eCTD, ACTD and CTD)
• Good communication skills (Written and Oral)
• MS Office (Excel and Power point), Adobe Professional
• Desirable to have hands on experience on RIMS preferably Veeva Vault, Trackwise

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
End Date : 25th September 2024