Senior Medical Writer

Silmed Scientific; Ernakulam; On-site; INR 600,000 - 900,000; Full time

Job summary

Silmed Scientific is seeking a Regulatory Medical Writer in India to join our team. The role focuses on authoring and reviewing regulatory submission documents for pharma products aiming for EU and US markets.

You will prepare CTD modules 2.4 and 2.5, enhance literature reviews, and present research data clearly to scientific audiences. 2–8 years of medical writing experience and strong communication are essential.

Qualifications

• Experience writing CTD modules 2.4/2.5 for EU submissions.
• 2–8 years in Medical writing with regulatory focus.
• Good Vancouver-style referencing and literature search skills.

Responsibilities

• Authoring and review of regulatory submission documents for marketing authorization in Europe and United States.
• Prepare CTD modules 2.4, 2.5, 2.6 and 2.7, expert reports and safety summaries.
• Create product monographs, SmPCs and patient information leaflets.
• Develop regulatory strategy reports and respond to development questions.

Skills

Regulatory writing

CTD 2.4/2.5 experience

Medical writing

Excellent communication

Literature search

Regulatory submissions

Education

MPharm or PhD Pharmacology

MBBS or MD Pharmacology

Tools

PubMed

EMBASE

Job description

We at Silmed Scientific are empowered with a vision of public health safety with scientific evaluation and assessment of healthcare products and ensuring global reach of safe products. With scientific talent force located globally, our endeavour is to build a uniqueworking culture.

Responsibilities

• Authoring and review of Regulatory submission documents for obtaining marketing authorization of pharmaceuticals in Europe and United States
• Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries (such as Module 2.4, 2.5, 2.6 and 2.7), expert reports, safety & efficacy summaries; Aggregate safety reports such as Periodic Safety Update Reports ( PSURs), bridging reports, Periodic Adverse Drug Experience Reports (PADER), policy papers, RMPs, etc.
• Product monographs, SmPCs, Patient information leaflets
• Regulatory strategy reports
• Advice on clinical/nonclinical Development questions/biowaiver reports
• Literature Search

Requirements

• MPharm or Ph.D. Pharmacology
• MBBS or MD Pharmacology
• Experience of 2-8 Years in Medical writing
• Excellent communication and Writing Skills.
• Prior experience in Regulatory Medical writing for EU Submissions with reputed pharma companies.
• Proven track record in writing CTD modules 2.4 and 2.5 for generic and bibliographic applications a must
• Ability to present research data to the target audience in a reader friendly manner.
• In-depth knowledge of various therapeutic areas.
• Knowledge of relevant guidelines related to structure and contents of the specific documents with a good understanding of Vancouver style of referencing.
• Familiar with searching medical literature databases such as PubMed, EMBASE, etc .