Job Title: Technical Officer - Report Writing
Ahmedabad, India
ORGANISATIONAL OVERVIEW
We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.
Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly.
Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.
JOB DETAILS
| Job Role | Report Writer |
| Reporting To | Report Group Lead |
| Department | Report Groups |
| Location | Ahmedabad |
| Overall Purpose | To write Clinical Study Reports complying with regulatory requirements |
KEY DELIVERABLES
▪ Knowledge of Clinical Study Report writing process for BABE (early phase) projects
▪ Understanding about ICH E3 report requirements
▪ Clarity of regulatory expectations for Report Writing and Medical Writing
▪ Teamwork, Resource management – training & quality improvisation steps
▪ Overall coordination with project team, QA team, Regulatory coordination, etc.
EXPERIENCE
1-4 yrs. in Report Writing.
EDUCATIONAL QUALIFICATION
M.Pharma (Pharmacoloigy) or Pharm.D.