Pharma Regulatory Writer - India - Greymatter Innovationz
2 weeks ago
Description
Join the forefront of digital innovation in healthcare with Greymatter Innovationz As a leading provider of digital solutions, we empower organizations to stay digitally relevant across diverse domains, technologies, and skillsets every day.
We are currently seeking talented individuals to join our team in the role of:
Pharma Regulatory Writer
Location: Anywhere is India/ Remote
Duration: 6 months
• At least 15 to 20 years of active medical writing experience. Oncology Therapeutic Area (TA) is preferred, although we are flexible if the experience is gained in other TAs.
• Independent authorship in the IND/CTA sphere. Documents to include, but not limited to, pre-IND briefing packages, modular clinical study protocols, pediatric development plans, and global investigational plans.
• Independent authorship in the NDA/BLA/MAA sphere. Documents to include, but not limited to, pivotal phase 3 CSRs, Module 2 and Module 5 documents, and major health authority responses (FDA, EMA, Health Canada, CDE, NMPA, ANVISA).
• Ability to independently interpret and communicate clinical data.
• Ability to author and deliver under tight (accelerated) timelines.
• Ability to thrive in multi-cultural, diverse teams spread across geographies.
• Excellent stakeholder negotiation skills.
• Experience as an OSP for major pharmaceutical and/or biotechnology clients.
• Sound knowledge of pharmaceutical drug development, including biostatistics and pharmacology.
• Ability to perform under minimal supervision.
At Greymatter Innovationz, we offer a dynamic work environment where you'll collaborate with industry experts and contribute to cutting-edge projects.