TAJNEEN NATASHA *** Monroe St, Apt ***, Hoboken, NJ 07030 • 848-***-**** • accio6@r.postjobfree.com

SUMMARY

• Seasoned professional with over 10 years of experience in diverse areas including Project Management in Regulatory

Affairs, Clinical Research and Development, Business & Systems Analysis, and Finance.

• Strong analytical thinking with good business acumen, combined with strong interpersonal, verbal, and

communication skills.

• Managed outsourcing of scientific projects to global vendors.

• Successfully facilitated and managed operations with cross-functional and virtual teams to drive results.

• Broad understanding of drug development and regulatory processes.

• Supported as a Subject Matter Expert as well as an analyst, and collaborated with IT to develop and implement data

integration system.

• Utilized Sarbanes Oxley controls compliance in grants generation, payment execution, month-end closing and accrual

processes.

• In addition to my project management role within Regulatory Affairs, I proactively assumed a special assignment to

extend my professional competencies and complement my MBA experience. The assignment entailed supporting

Merck Financial Services (Grant Management team) in processing Clinical Grants and payments in accordance with

established Financial Process & Control.

• Gained extensive knowledge of financial products and market through various trainings and MBA coursework.

Completed professional training on Financial Modeling.

• Self-motivated individual with ability to build strong relationship with peers and senior management.

PROFESSIONAL EXPERIENCE

Project Manager in Regulatory Affairs Apr 2012 - Nov 2013

Global Regulatory Operations (GRO), Merck & Co, Inc., Rahway, NJ

• Chaired Submission Planning and Management Team (SPMT) meeting to plan and ensure timely execution of

globally consistent and complete regulatory submissions.

• Liaised with Worldwide Regulatory Group to coordinate operational activities for Worldwide Marketing Applications

(WMAs), Clinical Trial Applications (CTAs), and amendments/supplements related to both investigational and in-line

marketed products.

• Managed multiple projects under tight timeline and served as the primary Point of Contact between SPMT and other

GRO functional areas to support regulatory operation planning activities.

• Effectively collaborated with cross-functional areas to ensure successful execution of new product filing strategies per

worldwide regulatory guidelines.

• Developed customized submission plans as per regulatory requirements, managed progress of submission plans, and

communicated plan variances to appropriate stakeholders to meet deadlines.

• Facilitated discussion to make decisions for regulatory projects, steered team members to comply with regulatory

guidelines, and addressed critical issues to achieve targeted milestones on time.

• Successfully filed a WMA for a new product within a year of assuming responsibilities in Regulatory Affairs.

• Skillfully negotiated across organizational levels to resolve conflicts and drive results.

Finance Specialist – Grant Processor (Special Assignment) Jun 2012 - Feb 2013

Merck Research Laboratories Financial Services, Merck & Co, Inc., Rahway, NJ

• Followed Sarbanes Oxley guidelines to approve grants (funding for external R&D costs), make payments to vendors,

and close month-end financials.

• Reviewed and maintained grants and all necessary documentation in accordance with internal regulation and financial

controls.

• Reviewed vendor payment requests and supporting documentation for final approval by management.

• Maintained invoice payment details (spend category, healthcare professional information) to comply with Sunshine

Act requirements related to Transparency Reporting.

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TAJNEEN NATASHA 727 Monroe St, Apt 304, Hoboken, NJ 07030 • 848-***-**** • accio6@r.postjobfree.com

Associate Research Scientist Nov 2011- Apr 2012

Clinical Development Laboratory (CDL), Merck & Co, Inc., Rahway, NJ

• Evaluated capability/capacity of external vendors and identified preferred vendors to provide business and logistical

input for clinical research services.

• Managed outsourced projects with external vendors by negotiating contracts, preparing requests for proposals, and

tracking project progress to ensure all requirements (timeline, budget, and scientific deliverables) were met.

• Liaised with Merck Clinical teams and external Clinical Research Organizations (CROs) in coordinating clinical trial

related operations and provided hands-on training at various sites in Europe.

• Collaborated with Scientific Capability Leads from various functional areas to develop and execute work plans and

communicated project progress to internal stakeholders.

• As a CDL SME, wrote business requirements and collaborated with internal IT to assist them write functional

requirements. Performed UAT and raised issues found during UAT for a successful integration of CDL data

management system with internal database.

Research Biochemist Jul 2007 - Oct 2011

Clinical Development Laboratory (CDL), Merck & Co, Inc., Rahway, NJ

• As a CDL SME, wrote business requirements and collaborated with internal IT to assist them write functional

requirements for successful implementation of optimal Watson LIMS (Laboratory Information Management System)

configuration, which converted sample tracking and data reporting system from paper to electronic.

• Performed UAT, trained users on LIMS, and provided expert-level support during post-implementation.

• Provided expert and timely support to end-users in creating and managing purchase requisitions and expense reports

within a SAP-based strategic initiative that Merck implemented to integrate and standardize business processes

globally.

• Led in-house development and validation of biomarker assays using a broad array of techniques to make experimental

data driven decisions for clinical programs.

Research Biologist Jul 2005 - Jun 2007

Department of Biologics, Merck & Co, Inc., West Point, PA

Research Scientist Apr 2005 - Jun 2005

Oncology, Hoffman-La Roche, Nutley, NJ

Research Associate Nov 2003 - Mar 2005

Department of Genetics, Rutgers, The State University of NJ, Piscataway, NJ

ACHIEVEMENTS

Received two Awards for Excellence for contribution in Clinical program and outsourcing management - 2011

•

Received a Special Achievement Award for contribution in Clinical program - 2010

•

Received an Award for Excellence for contribution in COMET implementation - 2010

•

Received an Award for Excellence for sample analysis to support a key Clinical program - 2007

•

EDUCATION

M.B.A., Finance and Pharmaceutical Management, (part-time, expected graduation May 2014)

Rutgers Business School, Newark, New Jersey. GPA: 3.84 for the 53 credits completed

B.S., Biomedical Engineering, Sept 1999 - May 2003

Rutgers University, College of Engineering, New Brunswick, New Jersey. Graduated with Honors degree

LEADERSHIP ACTIVITIES

Mentor - Women Investing In & Guiding Students (WINGS) Mentoring Program, September 2010 - April 2012

Partnership between Merck and Rutgers, The State University of New Jersey

• Mentored undergraduate students to develop their professional career and increase awareness of workplace culture,

organizational structure, and work/life balance.

• Attended professional programs with mentee to enhance their communication, networking, and interviewing skills.

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