Veena R
Phone no: 972-***-****
Emai id: ac7puu@r.postjobfree.com
Professional Summary:
Sr. Medical Writer with around 7 years of experience in preparing Phase 1 to Phase IV regulatory documents for pharmaceutical and CRO industries.
PROFESSIONAL EXPERIENCE
Sr. Medical Writer
Quintiles, Durham, NC
Feb 2014-Present
Major Responsibilities:
Prepared CSR study synopses in accordance with client Guidance Documents and the regulations of the FDA.
Reviewed Protocols, SAP’s and TFL’s.
Ensured assigned projects were delivered on time and under budget, through effective project management skills
Preformed quality control assessments of all assigned deliverables for other medical writers
Interacted with Medical directors, Clinical Research, Data Management and Stats people for review of serious adverse events.
Compiled and bookmarked CSRs for FDA submissions.
Sr. Medical Writer
Merck, North Wales, PA
May 2013-Jan 2014
Major Responsibilities:
Provided manuscript writing and editing services
Wrote Clinical documents for submission to regulatory authorities including regulatory responses, clinical development plans, investigator brochures, clinical study reports, integrated summary of safety and integrated summary of efficacy and DSURs.
Attended meetings with Medical, Data management and Stats People for review of ISS and ISE reports.
Wrote and edited Clinical Study Reports and patient narratives
Involved review of Protocol, SAP’s and TFL’s.
Developed Annual Reports, INDs and NDAs.
Medical Writer
Icon Clinical, North Wales, PA
Feb 2011-March 2013
Major Responsibilities:
Authored CSRs for drug and medical device clinical studies.
Reviewed SAPs and TFLs.
Oversaw timely internal and external reviews of draft and final documents
Compiled and bookmarked CSRs for FDA submissions.
Wrote and edited clinical study reports and narratives
Reviewed SAP’s and TFL’s
Authorized CSR’s for Drug and medical device studies.
EDUCATIONAL QUALIFICATIONS:
Bachelor of Pharmacy - Annamalai University, Chidambaram,India
Pharm.D (Post Baccalaureate) - Sri Ramachandra University, Chennai, India
COMPUTER SKILLS :MS Office: Word, Excel, PowerPoint, Outlook