Medical Writer

Résumé

Ms. Sonali Shrikant Dabir

************@*****.***

Summary

I have a total of 6 years and 6 months of experience in medical writing and editing. I am proficient at writing scientific/clinical study related information, consolidating data from various sources and creating summaries. I have good understanding of clinical studies, the drug development pathway, and the approval process. I am currently working as a Business Process Lead at TCS.

Employment History

Designation: Business Process Lead at Tata Consultancy Services (TCS)

Period: October 2016 – Present (1 year 6 months)

Profile:

Regulatory:

-Reviewing regulatory documents, such as Clinical Study Reports, Protocol, and Aggregate Reports (IBs, SSUR, DSUR, PSUR, PBRER) as per the guidelines.

-Peer review

Publications:

-Abstracts and Manuscripts

-Publications Coordination and Compliance Management

-Follow ICMJE guidelines for processing manuscripts

-Assessing clinical trial publications according to CONSORT guidelines

Designation: Process and Quality Analyst (Medical writing) at Crest (Part of the Springer Nature group)

Period: January 2016 - October 2016 (10 months)

Profile:

Subject Matter Expert:

-Revise standard operating procedure (SOPs) documents and guidelines

-Present weekly status update reports to senior management

-Provide production support by resolving tricky issues and queries from the production team

Client engagement:

-Weekly client meetings

-Propose and discuss modifications in the process during client meetings for improvement of the product

-Cascade relevant information to the team

Quality:

-Perform quality checks of clinical trial records to ensure compliance with internal guidelines

-Ensure implementation of process changes by organizing team meetings and product related sessions

Testing:

-Conduct User Acceptance Testing (UAT)

-Coordinate with the IT team during editorial tool releases

-Identify bugs, contribute toward process improvements, etc

Training:

-Train new hires in AdisInsight Clinical Trial sub-processes

-Identify training needs as well as cross-train accredited associates to perform a broader variety of tasks

-Develop/update training material for various topics in AdisInsight Trials

-Record and maintain training related information for all medical writers

Designation: Scientific and Medical Writer at Crest (Part of the Springer Nature group)

Period: January 2014 - January 2016 (2 years)

Profile:

Accredited in sub-processes of AdisInsight Trials, a clinical trial database

Writing clinical trial summaries with respect to the efficacy, safety, PK, PD data, etc

Consolidating information from various registry sources like ClinicalTrials.gov, European clinical trials database, Australia & NZ Clinical Trials Register

Creating and updating clinical trial profiles to assimilate the data of all the proprietary drugs in clinical phases

Follow-up of company websites to track the clinical progress of various drugs from clinical to marketing stage

Screening relevant clinical data from published clinical literature such as leading medical journals, abstracts presented in conferences, media releases, and clinical trial registries

Retrieving literature specific to the target by preparing strategies for search engines such as PubMed, to review and summarize the drug details and study results

Peer quality check

Designation: Level 2 Copy Editor (Language Editor) at Crest (Part of the Springer Nature group)

Period: August 2012 - January 2014 (1 year 5 months)

Profile:

Edit books and journal articles according to guidelines provided in style sheets and AMA style manual

Correct grammar and typos

Enhance readability and language of the manuscript

Perform quality checks

Poof reading

Format the manuscript as per instructions

Designation: Technical Assistant at Molecular Diagnostic Center

Period: January 2012 - August 2012 (8 months)

Profile:

Extraction of nuclear material (DNA and RNA) from various clinical samples

Testing for diseases like HCV, HBV, HIV, MTB, HSV, etc. on real-time thermal cycler

Designation: Trainee at Deenanath Mangeshkar Hospital

Period: November 2010 - February 2013 (3 months)

Profile:

ABO blood typing

Separating blood components and storage

Performing diagnostic tests of the collected blood

Working in blood donation camps

Issuing the blood bags to the patients as per the process

Technical Skills

Proficient with MS Word

Basic knowledge of Excel (simple macro), PowerPoint and Access

Academic Activities

Dissertation: 2009 - 2010

Designation: Trainee

Institution: National Chemical Laboratory

Project Title: Callus Induction, Organogenesis, and Embryogenesis from Nelumbo nucifera (Lotus)

Skills:

Writing a report for the project

Reviewing and analyzing literature from various databases, such as PubMed, PNAS central

Creating standard operating procedures (SOPs) from various references

Performing techniques like histology by Microtome, plant tissue culture, etc

Educational Qualification

Qualification

Year of Passing

University/Board

College/School

M.Sc. Microbiology

2010

University of Pune

Modern College, Ganeshkhind, Pune

B.Sc. Microbiology

2008

University of Pune

Modern College, Ganeshkhind, Pune

HSC

2005

Maharashtra State Board

MES Abasaheb Garware College, Pune

SSC

2003

Maharashtra State Board

Muktangan English School, Pune

Professional Objective

To enhance my knowledge for professional growth by securing a challenging position at work. To excel in tasks I undertake and prove an asset to the organization.

Personal and Contact Information

Mobile no.: 808-***-****

Address: Flat no. 302, Vinayak apartment, 117 Tulsibaugwale colony, Sahakar Nagar 2, Pune - 411009.

Date of birth: 10th January 1987

Age: 30 years

Gender: Female

Declaration

I hereby declare that the information furnished above is true to the best of my knowledge.

(Sonali S Dabir)

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