Medical writer

• Identify and incorporate relevant new publications for Radiesse and Ultherapy that are not currently captured in the existing matrix.
• Incorporate APAC-specific clinical publications, real-world evidence, and consensus papers.
• Assess the quality and robustness of existing claims and their supporting evidence.
• Refine current claims language to ensure scientific accuracy, clarity, and appropriate substantiation for both HCP and consumer audiences.
• Identify opportunities to strengthen competitive and differentiating claims where supported by evidence.
• Conduct a structured literature review and validate all references.
• Provide recommendations on claim hierarchy, evidence grading, and any gaps requiring additional substantiation.

Medical Writer – Claims Substantiation Specialist

• **Main Responsibilities: **
• - *To write and edit complex medical writing deliverables (including informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures) in accordance with sponsors’ and Excelya’s SOPs, guidelines and applicable legislation.*
• - *To coordinate cross-functional stakeholders and departments (including Clinical Operations, Biostatistics, Data Management, Regulatory Affairs, PV) to ensure the timely collection, review, alignment, and integration of scientific and clinical content required for the development of high-quality medical writing deliverables (including clinical study protocols, IBs, INDs).*
• - *To ensure the accuracy, consistency and regulatory compliance of all information, data and references included in the produced publications/documents, maintaining high standards of scientific quality.*
• - *To contribute to document quality control (reviewing data accuracy, formatting, appropriateness of language and compliance with industry guidelines).*
• - *To mentor and lead less experienced Medical Writers on complex projects, and to support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers.*
• - *To liaise with sponsors to negotiate changes where necessary and ensure alignment on deliverables and expectations.*
• - *To acknowledge and strictly comply with sponsors’ and Excelya’s SOPs, guidelines and appropriate local and international legislation. To keep himself/herself continuously informed on any amendments or updates of the above-mentioned guidelines, applicable laws and procedure*
• - *To perform a literature review according to the project’s requirements for its effective completion and according to the sponsors’ and Excelya’s SOPs*
• - *To review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency*
• - *To maintain familiarity with current industry practices and regulatory requirements, and guidelines that affect medical writing*
• - *To assist with any other project or other teams (Medical Advisor, Medical Monitor) of the Medical Affairs Department as requested by the superior*
• - *To support the Principal Medical Writer with the coordination of other Medical Writers or Senior Medical Writers*
• - *To act as a backup to other Senior Medical Writers and Medical Writers when needed*

Senior Medical Writer

• Responsible for medical writing including: PSURs/PBRERs PADERs ACOs DSURs RMPs
• QC and review of all written output from the operations team as required
• Supporting the project managers to determine scheduling of the aggregate reports for which they are responsible
• In conjunction with the Quality, Compliance and Training Manager identify areas for improvement and address via training, clarifying changes to SOPs/OGs/templates
• Complete quality documentation of aggregate reports
• Attending kick off meetings with new clients as required
• Attending audits and inspections as required
• Providing aggregate report training

Medical Writer II

• Leads the clear and accurate completion of medical writing deliverables
• Manages medical writing activities associated with individual studies
• Completes a variety of documents including clinical study protocols, clinical study reports, informed consents, and more
• Adheres to established regulatory standards
• Coordinates quality and editorial reviews
• Acts as peer reviewer for internal team
• Provides technical support, training, and consultation

Medical Writer – Future Roles

• Completes assignments independently or for more complex documents, under guidance of a mentor
• Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
• Ensures high integrity of data interpretation, following negotiation with document team
• Ensures the consistency and quality level of all documents that are issued
• Actively participates in all planning, coordination and review meetings
• Ability to work on 2-3 assignments simultaneously
• Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives
• Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers)
• Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments

Medical writer jobs in India

See all jobs on JobTailor

Medical Writer – Claims Substantiation Specialist

Senior Medical Writer

Medical Writer II

Medical Writer – Future Roles

Senior Medical Writer