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Medical writing, Narrative writing, quality control, MedDRA

Location:
Boston, Massachusetts, United States
Salary:
$70000
Posted:
February 19, 2018

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Resume:

ANJALI R. IYER

Address: Upcrest Road, Unit *, Brighton, MA-02135, email: ac4i7e@r.postjobfree.com, Ph No: 857********,

https://www.linkedin.com/in/anjali-iyer-32896255/

EDUCATION

Northeastern University, Boston, MA June 2018

M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices

Cranfield University, UK Aug 2011

M.S. in Clinical Research

University of Central Lancashire, Preston, UK Jun 2009

BSc. Hons. in Biomedical Science

PROFESSIONAL EXPERIENCE

Cognizant Technology Solutions – Mumbai, India Aug 2013 - Feb 2016

Narrative Writer – Medical Writing (Client: Boehringer Ingelheim)

Proficiently drafted, quality checked and medically reviewed over 1000 CSR-patient narratives across different therapeutic areas

Spearheaded 5 major projects successfully –managed task allocation, co-ordination, and training activities

Improved the quality of the narratives by acting as the point of contact of the independent quality control team

Generated quality control reports (scorecard) and conducted feedback sessions for the team of 25 associates

Conducted process and project specific trainings for new recruits by preparing process flows and training modules

Created quality control checklists, narrative writing templates, guidance documents, and defect tracking sheets thus ensuring processes and projects were always audit-ready

Awarded for the inception of ‘knowledge sharing sessions’ to improve quality and efficiency of narratives and for being one of the most productive and innovative employees.

SIRO Clinpharm Pvt. Ltd. – Mumbai, India May 2012 - Aug 2013 Medical Writer- Medical Writing (Client: Johnson & Johnson, Janssen Pharmaceuticals)

Drafted CSR narratives for different therapeutic areas like virology, oncology, and metabolic disorders

Competently quality checked CSR, IB, Protocols as well as manuscripts, abstracts, posters

Drafted table of studies and literature summaries

Maintained the literature management and documentation database (repository for publications of sponsor molecules)

Liaised effectively with other writers, communicating project information in a timely manner

Tata Consultancy Services – Mumbai, India Aug 2011 - May 2012

Work Flow Specialist-Clinical submission support (Client: GlaxoSmithKiline)

Collected, summarized, and reported clinical investigators’ financial interests (disclosures)

Executed quality checks of FDA financial disclosure forms (FIDS A& B) and statement of investigator FDA Form 1572

Generated the FDA financial disclosure reports Forms 3354 & 35455 and assisted in regulatory submissions

CERTIFICATIONS/TRAININGS

Lean with basic Six Sigma Bronze Certification

Trained at the Tata Memorial Centre for Cancer Research in the Cytogenetics Department

Obtained the Achiever’s League Advanced Scientific Writing Certificate (online course)

Completed the NIH Web-based training course "Protecting Human Research Participants"

SKILLS

Medical Writing, MedDRA Hierarchy, Regulatory Affairs, Quality Control

Pubstrat publication tool, Literature management and documentation system, eTrack system, (clinical trial management system), InForm (data management tool)

MS Office (Excel, Word, PowerPoint, Visio)



Contact this candidate