About This Role
This medical writer role involves authoring and reviewing clinical and regulatory documents, ensuring scientific accuracy and compliance. It suits a professional with experience in pharmacology, particularly in pharmacokinetic and clinical efficacy study domains.
Responsibilities
- Act as author or reviewer in the finalization or revision of clinical documents, including but not limited to: Investigators brochure (IB), Clinical study synopsis, Clinical study protocol (CSP), Informed consent document (ICD), Participant diary card (PDC), Clinical outcome assessment (COA) (including patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO)), Case report form (CRF) and its completion guidelines
- Support User Acceptance Testing (UAT) for eCRF, as applicable, in collaboration with the data management team
- Act as author or reviewer in the finalization or revision of clinical study reports (CSR)
- Ensure document consistency, scientific accuracy, and regulatory compliance in accordance with applicable ICH guidelines, regional regulatory requirements, and internal SOPs
- Support the development and maintenance of document templates, style guides, authoring standards, and process documents
- Support in evaluating and implementing technology-enabled solutions, automation tools, and AI-assisted approaches to improve medical writing efficiency, quality, and compliance
- Act as author or reviewer in the finalization or revision of regulatory submission documents, including clinical summaries and overviews (modules 2.5 and 2.7), selected common technical document (CTD) components (related to clinical trials), scientific justifications, health authority response documents, and presentation materials, as applicable
- Act as author or reviewer in the finalization or revision of regulatory submission slide decks, including scientific expert committee (SEC) and investigator meeting (IM)
- Act as author or reviewer in the finalization or revision of manuscripts based on CSR
- Collaborate with clinical development, medical affairs, clinical operations, biostatistics, data management, regulatory affairs, pharmacovigilance, quality assurance, and project management teams
- Coordinate document reviews and approvals with internal and external stakeholders
Requirements
- Preferably worked in both pharmacokinetic and clinical efficacy study domains
- MD (Pharmacology) Fresher, OR
- Ph.D (Pharmacology) with 0 to 2 years of experience, OR
- Pharm.D / M.Pharm / M.S. (Pharmacology) with 4 to 6 years of experience
