6 Ctd Modules Jobs

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3.0 - 7.0 years

0 Lacs

haryana

On-site

Role Overview: You will be responsible for planning and managing medical writing for Regulatory and Pharmacovigilance Verticals in compliance with applicable regulatory guidelines. Your main duties will include providing high-quality medical and scientific writing, offering technical consultation, demonstrating subject matter expertise, managing medical writing projects, collaborating with internal and external clients, and ensuring document output compliance with client specifications. Key Responsibilities: - Provide high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients. - Offer techn...

Posted 1 week ago

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5.0 - 9.0 years

0 Lacs

haryana

On-site

Job Description: As a Medical-Regulatory Writer Assistant Manager, your main responsibility will be to plan and manage Medico-Regulatory Writing in accordance with relevant Regulatory Guidelines. You will be expected to deliver high-quality medical and scientific writing, provide technical consultation and advice on strategy and regulations, demonstrate subject matter expertise, effectively manage writing projects to meet deadlines, collaborate with internal and external clients, and produce various types of reports including CTD Modules, Safety Reports, and Aggregate Reports. Key Responsibilities: - Conduct science reviews of aggregate reports - Ensure document compliance with client specif...

Posted 3 weeks ago

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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 months ago

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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 3 months ago

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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 3 months ago

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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 5 months ago

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