Senior Medical Writer

3 days ago

Bengaluru, Karnataka, India Navitas Life Sciences Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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

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