Sr Medical Writer

Job Summary

• The preparation and review of clinical study outlines.
• The preparation and review of the feasibility synopsis
• The preparation and review of protocols for clinical trials, Phase I to IV, and for bioavailability/bioequivalence studies
• The preparation and review of clinical study reports for Phase I to IV clinical trials and bioavailability/ bioequivalence studies for submission to regulatory authorities.
• The preparation of Common Technical Documents (CTD) for regulatory authority submission.
• The preparation of ICD, IB s, subject diary and other subject facing documents
• The technical review and ensuring the quality of medical writing documents
• Preparing departmental SOP under the guidance of departmental head/designee and quality assurance
• The preparation/review of SAE Narrative.
• Drafting and independently managing high-quality clinical documents, i.e. Protocol, ICD, IB, diary, and all other documents are part of regulatory submission (e.g. IND, NDA, BLA, MAA, 505B2, Biosimilar, hybrid applications)
• The preparation and review of Non-clinical Overview (Module 2.4), Clinical Overview (Module 2.5), Module 2.6, Module 2.7 and briefing documents. Development of ISS and ISE text Summaries
• The drafting of Pre-IND, Pre-NDA briefing packages, SAM briefing packages, orphan drug designation feasibility reports, and expedited approval processes
• Reviewing and supporting other departments for clinical trial-related documents (e.g. SAP, Mock TLFs, eCRF outline, any study-specific documents, etc.)
• Managing medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
• Creating impactful and accurate content for a variety of deliverables for our clients with moderate oversight
• Understanding client expectations and meeting those expectations through teamwork, adherence to deadlines, problem-solving, and scientific knowledge
• Ensuring compliance of documentation to internal organization standards and external regulatory guidelines
• Interacting with department head and staff members in data management, biostatistics, regulatory affairs, and medical lead as necessary to create writing deliverables
• Managing the administrative requirements of the medical writing department
• Any additional responsibility given by the head of department/designee/management

Desirable Skills and Experience

• Minimum of 5 years of experience as a professional medical writer who has contributed or written many regulatory MW documents
• Expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation of regulatory MW documents
• Proficient in Word, PowerPoint, Excel, and Adobe Acrobat; for developing and editing PowerPoint slides and PDF editor for dossier compilation. An advanced knowledge of PDF editor is a plus
• A basic understanding of the publication process and congress activities
• Excellent interpersonal skills for effective and professional liaison with the internal team, clients, Key Opinion Leaders, and other stakeholders
• A keen eye for accuracy
• A passion for writing and communicating science for different audiences
• Extremely high level of English fluency or English speaker
• Ability to multitask and prioritize work effectively
• Strong work ethic and ability to work as part of a cross-functional team

Qualifications

• Location: Bangalore
• Education: Medical/Pharmacy (PhD, MBBS, MD, M. Pharma/Pharma D)
• Role: Associate
• Department: Clinical Research

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