Key Resume Guidelines
- Font: Keep it simple (e.g., Times New Roman, Arial, Calibri).
- Order for Freshers:
- Name & Contact Info
- Professional Summary (Brief career objective)
- Skillset (Relevant technical & soft skills)
- Internship Experience (If any)
- Education (Degree, university, year)
- Projects (Academic/research projects)
Pro Tip:
✅ Add company logos (if applicable) to boost visibility and click-through rates.
Essential Skills for Clinical Research & Pharma Roles
1. Clinical Data Management (CDM)
- Study Start-up: eCRF & database design
- Study Conduct: Data collection, CRF tracking, data entry, review, validation, edit checks, UAT, discrepancy management, medical coding, SAE reconciliation
- Study Close-out: Database lock, clean file declaration
- Compliance: 21 CFR 11, CDM databases (Rave, Macro, Oracle Clinical)
2. Clinical Research
- Drug discovery, preclinical & clinical trials (Phases 0-IV)
- Protocols, reports, ICH-GCP, ethical guidelines, eCTD modules, dossiers
- Study designs (RCT, non-RCT, prospective/retrospective, case studies)
- Roles of CRA, CRC, Investigator, Sponsor
- Trial Master File (eTMF), ICF, CFR, CRF
3. Pharmacovigilance (PV)
- AE, ADR, SAE, SUSAR reporting
- Regulatory frameworks: 21 CFR 312/314, GVP, ICH E2A-F, CIOMS
- Causality assessment (WHO-UMC, Naranjo)
- Reporting systems (MedWatch, Yellow Card, Vigibase)
- Aggregate reports (DSUR, PSUR, PBRER)
- Medical coding (MedDRA, WHO-ART)
4. Medical Writing (MW)
- Regulatory Writing: Protocols, study reports, safety documents
- Scientific Writing: Manuscripts, abstracts, posters
- Medico-Marketing Writing: Brochures, product monographs, blogs
- Academic Writing: Thesis, medical books, research chapters
5. Regulatory Affairs (RA)
- DMF, Dossiers (IND, NDA, ANDA, BLA)
- Regulatory submissions & compliance
- eCTD modules (1-5)
- Key regulatory bodies (FDA, EMA, CDSCO)
