Deputy Manager, Medical Writing

Job Description Summary

The Medical Writer will possess an understanding of regulatory requirements for clinical evaluation, post-market clinical follow-up (PMCF) documentation and other related documentation, primarily Clinical Evaluation Plans and Reports (CEPs and CERs) and PMCF Plans and Reports.

The role may focus on authoring, quality control (QC), or a combination, depending on the candidate's strengths and team needs. Responsibilities include developing high-quality documents to ensure clarity, accuracy, and compliance with applicable standards, in alignment with project timelines and priorities.

This role provides flexibility to work remotely.

Job Description

P3-12892

Essential / Key Job Responsibilities (including Supervisory And / or Fiscal)

• Perform clinical evaluation, including planning, identification, appraisal, analysis, and reporting of clinical data. Prepare and update European and international Clinical Evaluation Reports (CERs) and summarize relevant literature for technical files / dossiers / registrations as required and per applicable SOPs. Ensure compliance with the applicable regulations and guidance documents.
• Author and maintain PMCF Plans and PMCF Reports in accordance with EU Medical Device Regulation and applicable regulations and guidance documents. Collaborate with cross-functional teams to define PMCF objectives, methodologies, and data sources. Interpret PMCF findings and integrate them into CERs, Risk Management documentation, and other regulatory deliverables.
• Coordinate with various departments (e.g., Regulatory, R&D, Clinical Affairs, and Quality) to assess and identify the necessary preclinical, clinical, and technical information.
• Generate and track timelines. Follow through on all tasks and ensure quality results.
• Develop or revise templates, SOPs, or guidelines for regulatory, medical, and clinical documents.
• Conduct scientific literature reviews and compile reports such as annual literature updates and periodic safety updates to global regulatory agencies.
• Participate in post-market surveillance activities by leading routine systematic literature reviews (e.g., screen articles against inclusion / exclusion criteria, extract data from included studies, interpret study results, synthesize literature, and prepare summaries into formal reports) for specific medical device groups or sub-groups.
• Organize and incorporate information, such as references, graphics, tables, and data listings, for the creation of robust and compliant technical documents.
• Critically write and edit scientifically complex documents with substantial intellectual content.
• Ensure content is clear, complete, accurate, and aligned with source documents. Conduct peer review (quality control) for documents authored by other medical writers.
• Maintain knowledge of current internal and external standards, regulations, and technologies related to this function.

Required Qualifications

Preferred Qualifications

Education And / or Experience

Required Skills

Optional Skills

Primary Work Location

IND Gurgaon - Aurbis Summit

Additional Locations

Work Shift

Skills Required

Quality Control, Microsoft Office, Regulatory Requirements