Project Management Coordinator

Nikunj Modi

**B Saint Alphonsus Street, Boston, MA 02 Email: **************@*****.***

(M) 857-***-**** Linkedin:www.linkedin.com/in/nikunjmodi

Summary:

A graduate student at Northeastern University with almost 2 years of experience in pharma industry, is actively looking for co-op/full time opportunity to work as a project coordinator to implement learning into real case scenario.

Education:

Master of Science in Project Management Expected July 2017

(Focused in Regulatory affairs and Clinical trial design) Northeastern University (Boston, MA)

Master of Business Administration in International Business July, 2014 Sikkim Manipal University, India

Bachelor of Pharmaceuticals April 2011

Gujarat University, India

Professional Experience:

West-Coast Pharmaceuticals works ltd., Ahmedabad, India Aug 2011-Sep 2013 Quality Assurance Officer

Authored, revised and reviewed quality GMP documents like product dossiers, BMR, SOP and validation protocols/reports.

Supervised quality checks of regular production activities in a regulated plant.

Tested of all finished goods and raw materials including medicine dosage forms and cosmetics.

Actively participated in process validation, execution of validation protocols and sampling as per protocol.

Calibrated instruments used in production and warehouse departments. research & development

Prepared the process validation, cleaning validation protocols and reports establishing with equipment cleaning procedures.

Involved in carrying out internal audits to ensure procedures, practices and facility is in compliance with regulatory guidance and maintained master copies of all the departments.

Technical Knowledge

Requisite knowledge of FDA regulations & ICH guidelines

Drug Submissions: IND, NDA, eCTD, ANDAs

Medical device submissions: 510(k), IDE, PMA

Clinical and non-clinical submission, Clinical trial documentation: Protocols, ICF, CRF and ICH- compliant clinical study reports

Preparation of investigator’s brochures (briefing/meeting packages)

Pharmacovigilance, Drug safety, Post market surveillance

Well versed with WHO, cGMP, GLP, SUPAC, and Validation Process.

Regulatory Affairs Strategic Planning Management, Regulatory Project Management.

Proficiency in Microsoft Office (Project, Word, Excel, PowerPoint), Adobe Acrobat

Key Skills

Good analytical capabilities

Decision-making/ Innovative

Working in cross-functionalteam

Medical/Technical writing

Negotiation and problem solving attributes

Organizational/Time management

Strong communication

Coordination to meet strict deadlines in project understanding

customer/business needs

Contact this candidate