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 Aggregate safety reports (e.g., PSURs, PADER), product monographs, SmPCs, patient information leaflets, and regulatory strategy reports. - Providing advice on clinical/nonclinical development questions and preparing biowaiver reports. - Conducting literature searches to support the regulatory writing process. To qualify for this role, you must meet the following requirements: - Hold an MPharm or Ph.D. in Pharmacology, or an MBBS or MD in Pharmacology. - Have 2-8 years of experience in Medical writing. - Possess excellent communication and writing skills. - Demonstrate prior experience in Regulatory Medical writing for EU Submissions with reputable pharmaceutical companies. - Show a proven track record in writing CTD modules 2.4 and 2.5 for generic and bibliographic applications. - Ability to present research data in a reader-friendly manner to the target audience. - Have in-depth knowledge of various therapeutic areas. - Familiarity with relevant guidelines for the structure and contents of specific documents, along with a good understanding of the Vancouver style of referencing. - Proficiency in searching medical literature databases like PubMed, EMBASE, among others.,

Posted 5 days ago

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