Regulatory Writing

Job Description

• Develop and review content for various regulatory documents; ensure quality as per setegulatory standards and compliance requirement. • Good understanding of global regulatory dossier formats and ACTD/CTD/NeeS/paper dossier format. • Candidate will need to author and/or review clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD for submission to the Health Authorities in EU and APAC markets, respectively. Key requirement: • Good medical/pharma/scientific knowledge that can be applied in developing content for regulatory documents • Experienced in the development and review of clinical and non-clinical documents under Module 2, 4 and 5 of eCTD, and Part III and Part IV of ACTD, for submission to the regulatory authority in EU and APAC regions, respectively • Good understanding of clinical trial and product life cycle EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD/BPharm/MSc EXPERIENCE: 4 to 6 years of Regulatory Writing/Reviewing experience LOCATION: Bangalore (Office-based/Hybrid) SKILLS: • Good communication skills (Written and Oral) • MS Office (Excel and Power point) PRINCIPAL RESPONSIBILITIES & ACCOUNTABILITIES: • Broad Area-1: Develop Content to Meet High CSAT Independently (Simple and Complex Projects) o Responsible for developing new drafts/updating existing content/review with quality, accuracy, timelines, and efforts, independently (Protocol, Informed Consent Form [ICF], Investigators Brochure [IB], clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD) o Responsible to run and review literature searches in various databases and screening articles to obtain required information for content development o Good knowledge of various regulatory guidelines and regulatory dossiers related to regulatory content development o Conduct quality checks to ensure the accuracy and consistency of data included in documents o Build expertise in extracting information from textbooks, authentic websites and articles for different deliverables and therapeutic areas o Demonstrate good technical competence on how to search the internet and books for referencing, copyrights, and plagiarism o 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 o Analyze challenges/limitations in content development and provide logical, unbiased, and rational recommendations for modifying quality standards or introducing newer ones o 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 o Review the content prepared by junior team members. Validate the authenticity of the content by performing data fact check o Guide team members on content client requirements and quality aspects of content development for different deliverables development (including but not limited to Protocols, IBs, ICF, clinical and non-clinical documents under Modules 2, 4 and 5 of eCTD and, Part III and IV of ACTD), o 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 o Be aware of all organizational, divisional, and client-related policies and procedures related to quality, information security and data privacy o Responsible to strictly adhere to quality standards for various deliverables as decided by the business unit or client o Responsible to maintain confidentiality and copyright rules for various deliverables/clients and company norms o Follow all the security rules with regard to various standards like ISMS, ISO, CMMI and client guidelines • Broad Area-4: Self-Development o Support in developing technical training programs for other team members relevant to the job o Responsible to complete client-specific training, if applicable o Responsible to build expertise in assigned deliverables through self-learning and formal trainings and stay abreast with current trends in the respective areas o Learn the basic skills to manage teams o Participate in and contribute to various continuous improvement initiatives or company driven initiatives Interested Candidate Please Apply - India.hr@infinitysts.com