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Medical Device

Location:
New York City, New York, United States
Posted:
November 16, 2018

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Resume:

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



Contact this candidate