Domnic Lewis International
Location
Bangalore | India
Job description
We are looking for Regulatory medical writers for the position of Lead and Specialist for the GBS setup of a Global Pharmaceutical MNC in Bangalore.
Position: Regulatory Medical Writer/ Lead/ Specialist
Level: Band 6, 7 and 8 respectively
Location: Bangalore
Work mode: Hybrid
Position Overview:
The key responsibilities of this position include performing medical writing tasks for trial and/or non-trial activities within clinical reporting . This involves the preparation of Protocols, Clinical Trial Reports (CTRs), Non-interventional study reports (NSRs), Layperson Summary (LPS), Investigator Brochure (IB), Regulatory response documents (Q&A), Clinical summaries, and Clinical overviews.
The role requires a significant degree of independence in task execution and clear and concise communication of clinical data. Timely, clear, and proactive communication and collaboration with stakeholders and colleagues globally are essential.
Additionally, the role involves contributing to process improvements, knowledge sharing, skill building, and mentoring and training other medical writers as needed. Building and maintaining good relationships with stakeholders and colleagues, effective planning to meet timelines, proactive problem-solving, and seeking help and advice from relevant individuals within GBS and HQ are crucial aspects of the role.
The position also involves challenging expert contributors on clinical documents to enhance the quality of their written contributions. Frequent international travel to attend meetings in HQ and CMRs, as well as conferences and courses worldwide, is an integral part of the job.
Qualifications:
Interested Candidates can share their updated resume at [HIDDEN TEXT]
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