RIMA DESHMUKH

Address: Gaithersburg, MD - *****, USA.

Contact Details: +1-240-***-**** E-mail ID:

acshn9@r.postjobfree.com

CAREER OBJECTIVE

. Seeking career in growth oriented organization in Clinical Research /

Pharmaceutical industry

. To utilize my education, professional experience and skills for

advancement of my knowledge and benefits of the organization

SUMMARY

. Total work experience of 7+ years in regulatory electronic document

publishing and pre-publishing activities including submissions to FDA

. Experience in working with global teams supporting FDA submissions,

including formatting and compilation of submission documentation, and

preparation of regulatory components

. Extensive experience in electronic document management system (EDMS)

including upload, retrieval, and maintenance of documents for

electronic submissions using the appropriate software and applications

. Experience in validation of the clinical data cited in the documents

like Clinical Study Reports, IND/NDA Modules, Clinical Overviews and

Summaries

. Active Regulatory Affairs Professionals Society (RAPS) member since

June 2015

ACADEMIC PROFILE

. Post Graduate Diploma in Regulatory Affairs: 65%, May 2012.

Global Institute of Regulatory Affairs (GIRA), Pune, India.

. Post Graduate Diploma in Clinical Research: 66.6%, August, 2008.

Academy for Clinical Excellence (ACE) at Bombay College of Pharmacy,

Santacruz (E.), Mumbai, India.

. Bachelor of Pharmacy: 70.5%, July, 2007.

University of Mumbai, India

Mumbai Educational Trust's (MET) Institute of Pharmacy,

Bandra (W.), Mumbai: 400050, India.

WORKING EXPERIENCE

ORGANIZATION NAME:

1. SIRO ClinPharm Pvt. Ltd., Thane, India.

Designation: Senior Clinical Medical Editor (Client - Baxter Healthcare)

Grade: Senior Executive 2 Tenure: April 2011 to

August 2014

Key Responsibilities:

. Perform Formatting Quality Check on documents like Protocols/Amendments,

IBs, Clinical Study Reports, Clinical Overviews and Summaries, DSURs,

ISS/ISE documents to ensure compatibility with electronic publishing

standards

. Perform Data Quality Check to ensure validity of the data cited, against

the sources (summary tables, listings, etc.), in documents like CSR,

Clinical Overview and Summary, DSUR, ISS/ISE, etc.

. Compile CSR appendices (Consent Forms, CRFs, Investigator list and CVs,

Listings and Tables, etc.) and ensure submission readiness prior to

publishing

. Make the PDF files ready for electronic submission using ISI toolbox

Secondary Responsibilities:

. Conducting the training sessions for newly joinees in the team

. Responsible for creation and updating of the training material

Achievements:

. Promoted from the grade "Senior Executive 1" to "Senior Executive 2" in

2013-2014 promotion cycle

2. Tata Consultancy Services (TCS), Nerul, Navi Mumbai, India.

Designation: Document Specialist (Client - GlaxoSmithKline Group of

Companies).

Grade: Senior Process Associate Tenure: July 2007 to March 2011

Role Objective:

To manage documents in the electronic document management system throughout

their lifecycle, providing technical expertise in preparing study related

documents for publishing, ensuring that these documents and any supporting

material are compliant with technical publishing standards.

Key Responsibilities:

. Management of documents in electronic document management system and

working with Regulatory Publishers to ensure the modules are ready for

regulatory submission

. Managing lifecycle of documents like Protocols/Amendments, IBs, SAP,

IND/NDA reports till they get published

. Maintaining correct status flags and version increments

. Compile supporting documents of CSRs that are required for regulatory

submissions

. Check for the copyright clearance status of the Articles / Publications

supporting CSR /IND Annual Reports

. Co-ordinate with Statisticians to ensure the availability of complete

statistical data for publishing

. Interact with Medical Writers from different Therapeutic Areas

(Respiratory, Oncology, Cardiovascular, Metabolic, Neurology, Psychiatry,

Musculoskeletal, Inflammation) to provide training, coaching and

awareness of their responsibilities with regards to documents they author

to ensure compliance with the standards

. Interact with Study Managers for obtaining supporting documents

(Investigator Lists, CVs, Consent Forms, CRFs, COAs, Audit Certificate,

Reporting and Analysis Plan, Statistical data etc.) to complete CSR

bundle

. Obtaining all the mandatory modules of IND / NDA bundle from Medical

Writers and compliance checking these modules prior to publishing

. Ensuring customer satisfaction by timely delivery of quality output

Secondary Responsibilities:

. Internal Quality checker for GSK Document Specialist Team

. Quality coordinator for TCS to ensure that audit requirements are met.

This included maintaining training records and ensuring regular updating

of these records by team

. Conducting audit awareness sessions prior to audits to make the team

audit compliant

. Played pivotal role in preparing the training materials, guidance

documents & various other presentations helping to streamline the

processes

Achievements:

. Promoted from the post of "Process Associate" to "Senior Process

Associate" in 2010 promotion cycle

. Received GSK "Rewards & Recognition Awards" for timely delivery of

critical documents required for FDA Submission on urgent basis

. Received GSK "Certificate of Excellence" for quality performance and

timely delivery of 3 crucial oncology submissions

. Received "TCS Gems Award" (Star of the Month and Star of the Quarter) for

contribution towards achieving stringent timelines for crucial FDA

Submission, standardizing the new process improvement practice approved

by client and for keeping the team compliant in terms of quality of the

training records

. Received "TCS Gems Award" (Champions League) for dedication, commitment

and contribution towards the organization

. Received TCS - "Pat on the back award" for timely delivery of a high

priority Oncology Protocol and for contributing towards achieving

important timelines for crucial FDA submission

SKILLS

. Regulatory affairs global submissions including FDA submissions

. Knowledge and understanding of GCP, GMP, QA

. Document lifecycle and electronic document publishing in EDMS (electronic

document management system)

. Computer Literacy: MS-Word, Acrobat PDF, ISI Toolbox, EDMS, PowerPoint

. Proficient in English written and oral communication

. Ability to perform well in team as well as individually

. Good Analytical problem solving skills

TRAINING

Organization Name: Cipla, Ltd.

Completed internship as a trainee during the course of B. Pharm. Visited

Production, Quality Control and Quality Assurance Departments.

Total Experience: 1 month (15-May-06 to 14-Jun-06).

PERSONAL PROFILE

> Nationality: Indian

> Languages Known: English, Hindi, Marathi

> Hobbies: Reading, listening to music, playing badminton

> VISA Details: L2 Visa valid till April 2017

> Work permit (EAD) valid till January 2017

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