Medical Microsoft Office

DEVI M PALANICHAMY

*************@*****.*** / 615-***-****

A scientifically-driven medical writer who writes and/or edits regulatory, clinical, or commercial documents relating to the development/marketing of drugs and biologics. Experienced in authoring clinical study reports (CSRs), Investigator’s Brochures, annual reports, study protocols and amendments, informed consent documents, study narratives, IND and briefing documents. Working knowledge of publication guidelines of AMA and ICJME.

EDUCATION

Masters of Biotechnology, BITS, Pilani, Rajasthan, India

Bachelor of Pharmacy, MGR Medical University, India

PROFESSIONAL AFFLIATION

American Medical Writers Association: MEMBER

MWC Certification – exam

WORK EXPERIENCE

Xertz Business Solutions LLC

Consultant Aug 2016- Till Date

Worked with the clinical team, prepared documents such as Clinical Study Protocols, Clinical Study Protocol Amendments, Clinical Study Reports (full, synoptic, and abbreviated reports) and Investigator brochures.

Reviewed regulatory documents (e.g., protocols, amendments, IBs, CSRs, eCTD summary documents (2.5, 2.7), appendices) for content, data accuracy against source data, consistency between the document text and the in-text tables, grammar, syntax, style, and compliance with style guides, regulatory guidelines, and publishing requirements

Compiled and assembled components (appendices, attachments, tabulated summaries) of clinical documents, including clinical study reports, clinical protocols, investigator’s brochures, and CTD clinical summary documents for marketing applications

Serve as a resource for medical writers, providing on-boarding and mentorship

Develop writing strategy and assist with organization, content, timelines, and resource allocation

Coordinate meetings with publication leads, statisticians, internal authors, and external subject matter experts to plan, develop, and execute publication projects

Communicate effectively with cross-functional stakeholders and external subject matter experts to ensure delivery of high-quality publications on time

Perform data analysis/visualization and literature searches

Develop, draft, and edit publications including figures, tables, and bibliography

Proficiency in using Microsoft Office applications, Power point and document management software’s Datavision.

Noevos Market Research and Analysis

Sr. Medical Writer Nov 2014-Jan 2016

Summarize salient medical information from large volume of scientific and clinical data

Prepare high quality medical and scientific document from planning and coordinating literature search through final delivery

Expertise in conducting specific literature searches on PubMed, MedLine or other similar medical literature databases.

Compiled and assembled components (appendices, attachments, tabulated summaries) of clinical documents, including clinical study reports, clinical protocols, investigator’s brochures

Prepared clinical trial protocols and clinical study report shells for phase 1 and phase 2 clinical research studies

Critically analyzed, synthesized, and presented complex information.

Prepare clinical case studies for review and publication

Write clinical abstracts, posters, and manuscripts for assigned studies.

Check accuracy and review styling of references per AMA style, using PubMed

Maternity Break - March 2010- March 2013

BrainWave Biosolutions Limited, India

Project Manager / Medical Writer July 2002 – Feb 2010

Market Analyst

Identification of KOL from public domain data, tiering and ranking based on the KOL’s credentials (secondary market research). Trend analysis of KOL using PIVOT tables.

Develop SOPs and training material for research teams to perform competitor analysis

Analyzing and Reporting data using SPSS tools identify trends, issues and exceptions and develop strategic improvements.

Employ research methodologies, design research and conduct insightful secondary market research

Literature data mining and Patent data mining by employing analytical and market research techniques

Medical Writing

Critical Appraisal of CSR and Articles from Medical Journals like lancet, NEJM – Narratives on Introduction & background, Purpose of study, Type of study, Methods, Outcome and Critical review.

Study Protocol to CRF Questionnaire design – Reviewing Protocol & CRF Completion guidelines, collecting different health –instruments and drafting Questionnaires to approval.

Patient Narratives – PSURs

Critical Analysis of Clinical Data – Conduct comprehensive literature search and perform critical analysis of clinical data.

Medical News Writing – Rewriting medical news published from pioneer new sources with additional information from parent article in a way that is useful to Investigators, medical staff and patients.

Medical Content for On-line Medical Portals – Writing narratives, FAQ’s for CME Peer reviewed portals.

Scientific writing - Blurbs, News, Summary, Whitepapers, Product Information for Internationally reputed Pharmaceutical magazines as Digital Editor. (Putman Media, Inc).

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