We are seeking a Medical Writer / Senior Medical Writer to join our team in Bangalore (office-based/hybrid model). In this role, you will leverage your strong medical, pharmaceutical, and scientific knowledge to develop and review high-quality content for a variety of regulatory documents. You will ensure content adheres to established regulatory standards and compliance requirements, contributing significantly to the integrity of our submissions.
Role Purpose
Develop and review content for various regulatory documents, ensuring quality as per set regulatory standards and compliance requirements. You will have a good understanding of global regulatory dossier formats, including ACTD/CTD/NeeS/paper dossier formats.
Skills
- Good communication skills (Written and Oral)
- Proficiency in MS Office (Excel and PowerPoint)
Principal Responsibilities & Accountabilities
Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects)
- Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently for documents such as Protocols, Informed Consent Forms (ICF), Investigators Brochures (IB), and clinical and non-clinical documents under Modules 2, 4, and 5 of eCTD.
- Responsible for running and reviewing literature searches in various databases and screening articles to obtain required information for content development.
- Possess good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development.
- Conduct quality checks to ensure the accuracy and consistency of data included in documents.
- Build expertise in extracting information from textbooks, authentic websites, and articles for different deliverables and therapeutic areas.
- Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism.
- Follow the best practices while executing projects in the team with regard to processes, communication (internal and external), documentation, and technical requirements like language, grammar, style, content search, summarizing, data conflicts, and referencing.
- Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones.
- Work with internal stakeholders for project execution and actively participate in team meetings and client meetings from a content perspective.
Broad Area-2: Review Content of Team Members
- Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact checks.
- Guide team members on content client requirements and quality aspects of content development for various deliverables (including but not limited to Protocols, IBs, ICFs, clinical and non-clinical documents under Modules 2, 4, and 5 of eCTD, and Part III and IV of ACTD).
- Guide team members to develop content outlines for different target groups that are accurate, clinically relevant, reflecting the most recent medical advances, and in accordance with established content development practices, in collaboration with clients and team leads.
Broad Area-3: Process Adherence and Compliance
- Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security, and data privacy.
- Responsible for strictly adhering to quality standards for various deliverables as decided by the business unit or client.
- Responsible for maintaining confidentiality and copyright rules for various deliverables/clients and company norms.
- Follow all the security rules with regard to various standards like ISMS, ISO, CMMI, and client guidelines.
Broad Area-4: Self-Development
- Support in developing technical training programs for other team members relevant to the job.
- Responsible for completing client-specific training, if applicable.
- Responsible for building expertise in assigned deliverables through self-learning and formal trainings and staying abreast with current trends in the respective areas.
- Learn the basic skills to manage teams.
- Participate in and contribute to various continuous improvement initiatives or company-driven initiatives.
