Develop and update process documents, SOPs and trackers for Medical Writing Function
Prepare, review and edit clinical trial protocols, investigator's brochure (IB), Case Report Form (CRF), Informed Consent Document (ICD) and Patient diaries (if applicable)
Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs
Ensure all study documents like protocol, ICD, CRF, patient diaries & CSRs are prepared in alignment with ICH-GCP, CDSCO guidelines and all applicable regulatory guidelines
Conduct quality check (QC) of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents
Lead review cycles of documents with respective stakeholders for timely completion
Finalize publication plan for each manuscript in coordination with respective medical affairs personnel
Prepare and review manuscripts - original research articles, review articles, meta-analyses, consensus / expert opinion, abstracts, posters and other relevant documents, in alignment with IJCME, GPP3 and any other relevant guidelines
Work cohesively with internal stakeholders including Clinical research team, Medical Affairs team, business team, regulatory affairs, legal team, compliance team and project specific other functions
Strong coordination with external stakeholders including investigators, Key Opinion Leader (KOL) authors, Biostatisticians, Data management team & medical association office bearers
Vendor management for Medical writing vendors, in accordance with Sun Pharma policies and procedures.
Ensure execution of MSAs, project contracts, and invoice management
WHO YOU ARE:
3-5 years' experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies
Preferably Pharmacy post-graduate /graduate
Formal training in Medical Writing will be value add
Well versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines and PRISMA statement
Experience of medical writing for complex publications (e.g. Meta-analysis, consensus, guidelines) with successful outcome will be of added advantage
Experience in publications in indexed journals
Training in clinical trial methodologies, research design and ICH - GCP & publication guidelines
Relevant knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
Strong academic record with knowledge of research methodologies & publication processes for different type of publications