Job Description

We are currently seeking a Senior Medical Writer to join our growing team. Within the role, you will be responsible for:


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

Bangalore, India

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

Associate

Clinical Research

Full Time