10.0 - 14.0 years

0 Lacs

karnataka

On-site

The Principal Medical Writer is an individual expert contributor with 10-12 years of experience, proficient in Clinical and Regulatory document writing, CSR, Briefing Document, Module (m2.5, m2.7.1 & m2.7.2). You will be based in Bengaluru and will independently execute complex writing assignments with a thorough understanding of clinical trial designs and interpretation of statistically analyzed research data. Your responsibilities will include writing various clinical regulatory documents, ensuring high quality and compliance with GSK standards and global regulatory requirements. You will work in a matrix team, plan and produce clinical dossier documents for regulatory submissions worldwide, and effectively manage projects of increasing complexity. Additionally, you will have the ability to assess complex situations, apply scientific knowledge, and interpret clinical data effectively. The ideal candidate will have a PhD or relevant working experience within the life sciences space, along with clinical regulatory writing experience in the pharmaceutical industry. You should demonstrate leadership skills, experience in multicultural settings, and proficiency in interpreting, describing, and documenting clinical data. Strong computer skills, knowledge of ICH/GCP, and excellent English language skills are essential for this role. GSK, a global biopharma company, is committed to uniting science, technology, and talent to positively impact the health of billions of people. At GSK, we aim to create an inclusive environment where our employees can thrive and be inspired to be the best they can be. If you share our ambition and want to contribute to getting ahead of disease together, join us on this exciting journey. Please note that GSK does not accept referrals from employment agencies without prior written authorization. If you receive unsolicited emails or job advertisements not ending in gsk.com, please disregard them and inform us at askus@gsk.com for verification.,

Posted 1 week ago

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