Medical Writer

Medical Writer:

Preferably have worked in both - pharmacokinetic and clinical efficacy study domains.

Qualification:

MD (Pharmacology) Fresher, OR

Ph.D (Pharmacology) 0 to 2 years, OR

Pharm.D / M.Pharm / M.S. (Pharmacology) 4 to 6 years

Job description details

1. Act as author or reviewer in finalization or revision of the following clinical documents (including, but not limited to), in coordination with cross-functional stakeholders:

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), clinicianreported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO).

Case report form (CRF) & its completion guidelines; support User Acceptance Testing (UAT) for eCRF, as applicable, in collaboration with data management team.

Clinical study report (CSR).

2. Ensure document consistency, scientific accuracy, and regulatory compliance in accordance with applicable ICH guidelines, regional regulatory requirements, and internal SOPs.

3. Support development and maintenance of document templates, style guides, authoring standards, and process documents.

4. Support in evaluating and implementing technology-enabled solutions, automation tools, and AIassisted approaches to improve medical writing efficiency, quality, and compliance.

5. Act as author or reviewer in finalization or revision of the following clinical documents (including, but not limited to), in coordination with cross-functional stakeholders:

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.

Regulatory submission slide decks including (but not limited) scientific expert committee (SEC), investigator meeting (IM).

6. Act as author or reviewer in finalization or revision of manuscripts based on CSR.

7. Collaborate with clinical development, medical affairs, clinical operations, biostatistics, data management, regulatory affairs, pharmacovigilance, quality assurance, and project management teams.

8. Coordinate document reviews and approvals with internal and external stakeholders.