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2.0 - 8.0 years
0 Lacs
kochi, kerala
On-site
You will be working at Silmed Scientific, an organization dedicated to public health safety through scientific evaluation and assessment of healthcare products. The company aims to ensure the global availability of safe products and fosters a unique working culture. As a Regulatory Medical Writer at Silmed Scientific, your primary responsibilities will include: - Authoring and reviewing Regulatory submission documents for pharmaceutical marketing authorization in Europe and the United States. - Developing Common Technical Document (CTD) modules like nonclinical and clinical overviews & summaries (Module 2.4, 2.5, 2.6, and 2.7), expert reports, safety & efficacy summaries, as well as Aggregat...
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
haryana
On-site
As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specificati...
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
haryana
On-site
The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the deli...
Posted 2 months ago
10 - 15 years
15 - 25 Lacs
Noida
Remote
Immediate Joining | Remote | | Part Time - Visiting Faculty Impart Training Sessions for the students of Drug Regulatory Affairs Weekend Training Sessions Prepare presentations Deliver Training Sessions
Posted 4 months ago
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