The Clinical Analyst has responsibility, with supervision, for preparing documents on the projects they are assigned, providing critical information on progress and project needs to their management and other writers. They ensure that documents are written consistent with company and regulatory guidelines.
Responsibilities/ Authorities :
-With supervision, plan and prepare of a variety of clinical documents (eg; Clinical CTD modules, investigator s brochures, clinical study reports) by organizing, critically examining, and interpreting scientific and statistical data.
-Work effectively with other writers, communicating project information in a timely manner.
-Work to ensure documents are of high quality, scientifically accurate, meet company standards and regulatory requirements (eg, SOPs ICH and FDA guidances) and reflect a consensus among team members that is acceptable to all appropriate reviewers
Requirements:
-No special physical demands.
-Major part of work done in office environment.
-High degree of accuracy and attention to detail.
-Good decision making ability.
-Demonstrated strong writing skills and has written publications.
-Ability to analyze, understand and interpret complex scientific data from a broad range of scientific disciplines.
-Ability to manage timelines
Roles and responsibilities:
– Monitoring websites and other data sources – Data extraction from publications, websites and regulatory documents – Develop reports based on literature, regulatory and pharmaceutical reimbursement
Desired Candidate Profile:
– Be a graduate in life sciences – Have very high attention to detail
Education : B.Pharmacy/M.Pharmacy/ PharmD, Any Life Science, Paramedical, Medical Graduates and Post Graduates (Pharmacy, Physiotherapy, Nursing, , Biotechnology, Plant Biology, Biology, Bio-Medical graduates, Zoology, Botany, Bioinformatics, Genetics, B.O.T, Microbiology, Biochemistry ,Endocrinology, Nutrition & Dietetics, Anatomy, Physiology , Chemistry, Medical Lab Technology, Health Education, M.B.B.S, B.D.S, B.H.M.S, B.A.M.S, etc.)
Freshers are encouraged to apply. Training will be provided