Medical Writing – Remote (Haryana) at BD

Are you an experienced medical writer with a strong grasp of regulatory documentation for medical devices and a flair for precision and clarity? We are excited to present a compelling opportunity with a leading medical-device organisation based in Haryana (remote working allowed) for the position of Deputy Manager, Medical Writing. In this role, you will author and quality-control key documents including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) Plans & Reports, in full compliance with EU and international medical-device regulations. This remote-friendly role suits professionals with strong scientific writing, regulatory insight, and device-clinical evidence experience.

Responsibilities

• Perform clinical evaluation activities: plan, identify, appraise, analyse and report clinical data for medical-device technical documentation.
• Author and maintain high-quality European and international Clinical Evaluation Reports (CERs) and CEPs; summarise relevant literature for technical files/dossiers/registrations in line with SOPs and applicable standards.
• Develop and execute PMCF Plans and PMCF Reports, aligned with the EU Medical Device Regulation (MDR) and other global regulatory requirements.
• Collaborate with cross-functional teams (Regulatory, R&D, Clinical Affairs, Quality) to assess required preclinical, clinical and technical information for devices.
• Generate and track project timelines; ensure compliance with milestones and deliverables.
• Develop or revise templates, SOPs or internal guidelines for regulatory, medical and clinical documents.
• Conduct systematic literature reviews (screening, extraction, synthesis) for post-market surveillance and prepare formal summary reports for device groups or sub-groups.
• Organise references, graphics, tables, data listings to support robust and compliant technical documentation.
• Edit, peer-review and perform quality control of scientific/clinical documents authored by others, ensuring clarity, completeness, accuracy and alignment with source documents.
• Maintain up-to-date knowledge of internal and external standards, regulations and technologies relevant to medical-device clinical-evidence documentation.

Qualifications & Skills

Required:

• Excellent English writing skills, ability to use medical terminology accurately and communicate persuasively.
• Strong working knowledge of Microsoft Office suite.
• Ability to manage multiple projects, work independently with minimal supervision and collaborate across multi-disciplinary teams.
• Rapid understanding of therapeutic areas, medical-device portfolios, business objectives, clinical data/evidence.
• Analytical and problem-solving skills: anticipate issues/delays and proactively minimise project impact.
• Ability to interpret statistical results of clinical studies, summarise complex results succinctly and present them clearly to various stakeholders.
• Excellent attention to detail: ability to identify inconsistencies, gaps and errors in complex technical content.
• Knowledge of narrative and systematic literature reviews; ability to interpret and present data accurately.
• Strong understanding of scientific or clinical research and methodologies.

Preferred:

• Experience in authoring CEPs, CERs, PMCF Plans and PMCF Reports for medical devices.
• Familiarity with European clinical-evidence requirements, including MDR, MEDDEV 2.7.1 and other global regulatory guidance.

Education & Experience:

• Bachelor’s degree in a science, medical-related field or medical/technical writing (advanced degree preferred) + 1-3 years of medical-device experience, OR 5+ years of medical-device clinical-evidence / medical-writing experience.

Benefits & Work Environment

• Fully remote role (with primary work location listed as Gurgaon-Aurbis Summit, Haryana).
• Opportunity to work on high-impact regulatory documentation for medical-device clinical evidence across global markets.
• Cross-functional collaboration (Regulatory, R&D, Clinical Affairs, Quality) which offers professional growth and exposure.
• Engage with cutting-edge medical device portfolios and international regulatory frameworks—ideal for writers aiming to deepen their expertise in device clinical evaluation and post-market surveillance.
• Flexibility working remotely, allowing better work-life balance while interacting with a dynamic scientific and regulatory team.

Application Instructions

Application Link