Job Description

We are currently seeking an Assistant Manager – Medical and Scientific Affairs to join our growing team. Within the role you will be responsible for:

• Drafting and independently managing high-quality clinical documents i.e. Protocol, ICD, IB, diary, and all other documents that are part of a regulatory submission (e.g. IND, NDA, BLA, MAA, 505B2, Biosimilar, hybrid applications)
• The preparation and review of the 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
• 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 leads as necessary to create writing deliverables
• Managing the administrative requirements of the medical writing department

Desirable Skills and Experience

• Minimum of 10+ years 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. Advanced toll knowledge of PDF editor plus
• A basic understanding of the publication process and congress activities
• Excellent interpersonal/communication skills for effective and professional liaison with the internal team, clients, KOL, and other key stakeholders
• A keen eye for accuracy
• A passion for writing and communicating science to 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

Bangalore, India

Medical/Pharmacy graduate (PhD, MBBS, M.Pharma/Pharm D)

Project Manager

Clinical Research

Full Time