Project Management

Sameera Tak

Breisacherstrasse -**, BASEL ****, Switzerland

Telephone: + (41-797-***-*** Email: *********@*****.**.**

Project Lead / Business Analyst – Clinical Packaging and Resource Management

Versatile and resourceful international professional offering over 6 years’ experience in managing Project & Resources and developing Strategic Documentation, SAP expertise in Clinical Supplies & Resource Planning for the Pharmaceutical industry.

Creative strategist and an effective planner with extensive knowledge of Clinical Supplies & related IT applications and excellence in translating & integrating business & technology needs.

A Certified Project Management personnel with expertise in implementing Resource based projects and developing Label & Packaging design in accordance with the GCP & GMP guidelines.

Skilled in leading Project Transformations and utilising Pharmaceutical Knowledge, Strategic Insight and Sharp Planning Skills to manage Business Operations and business objectives.

Extensive knowledge in Lean implementation on Clinical Labelling & Documentation Application, Validation & Rollout Planning, Process Design and Labelling Software in Drug Supply Management through process optimisation.

Subject Matter Expert conversant with the intricacies of the protocol and study no.23 for TRC consisting of the Bacteriology, Randomization & Stratification modules and Report Generation of Trial components.

Outstanding track record in serving as a Change Leader & Focal Point for Resource Planning; undertaking extensive process improvement strategic initiatives in compliance with the project & Global organizational objectives.

Recognized for hands-on experience in performing Pre-QA & GMP checks on the Translation Database and random packaging documentation including label designs & pack designs.

Contributed to successful strategies leading to effective operational excellence and improved work ethics

An excellent communicator - with demonstrated ability to lead & train Global teams and interact with people of diverse ethnicities and comfortable working in a multi-cultural set-up.

Facilitation and communication skills – setting up Global communications like Town-halls , Global news letters on Change Management.

CORE COMPETENCIES

Strategic Planning Project Management Documentation Specialization in Clinical Supplies Line Unit Checks Randomization & Clinical Labelling in SAP Resource Management Multi Level Packaging & Master Data Maintenance Clinical Labelling & Packaging Tools Business Process Modelling SAP Project Implementation Performance Benchmarking & Process Driven Initiatives Global Team Communication Certified in 21 CFR Part 11 Lean Projects for Clinical Labelling Management Resource Capacity Planning

KEY ACHIEVEMENTS ACROSS CAREER SPAN

Spearheaded roles as a ‘Translation Specialist’ for the internal Database of the translations used for Labels in Clinical Supplies for 9 – Novartis Pharmaceuticals Pvt. Ltd., Hyderbad, India.

Led the Resource & Planning Tool implementation through successful Project Management and ensured smooth roll out by associating with Business Leads from 5 cross functional units within the DSM during the first 6 months of employment. – Novartis Pharma AG, Basel Switzerland

Achieved 3 performance awards for implementing Clinical Packaging & Labeling and CSR projects

Successfully accomplished mapping of DSM Processes in Mega Tool whilst serving as an experienced Process Designer at Novartis Pharma AG, Basel, Switzerland

CAREER PROGRESSION

Business Support Manager Jan 2010- Till Date

Drug Supply Management – TRD (Technical Research & Development)

Novartis Pharma AG, Basel, Switzerland

Multinational pharmaceutical company with core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health

Contributing to the development of strategic projects and initiatives through establishing project SLAs

Developing strategic documents & presentations for the Global Leadership Team & global DSM

Leading the development of the DSM planning tools and coordinating related activities between DSM & IT Units.

Conducting training for new-hires as well as for the team during process transitions or tools upgrades.

Devising process improvement initiatives and establishing communication strategy for assigned strategic projects

Developing communication platforms & tools in conjunction with stakeholders.

Collaborating with cross functional teams including departmental planners & strategic project leaders to ensure project implementation in compliance with Global DSM objectives.

Identifying benchmarks and best practices and working on SAP implementation across Supply Chain.

Facilitator for the Global Townhalls – Drawing up charters ,chairing the Q & A.

Acting as a focal point for FTE planning and monitoring multi level packaging & master data maintenance during the SAP project implementation.

Leading Lean Project for Labelling software in Drug Supply Management through process optimisation.

Project Lead for SAP implementation at Drug Supply Management – Hyderabad Site.

Executive & Senior Executive Jan 2007 – Dec 2009

Novartis Healthcare Pvt. Ltd. Hyderabad, India

Multinational pharmaceutical company with core businesses in pharmaceuticals, vaccines, consumer health, generics, eye care and animal health

Accountable for implementing a Clinical Labelling tool at DSM India site and Documentation & Phrase Library Maintenance activities

Played a significant role in establishing the documentation group and participated in the roll out of tools

Performed Line Unit checks for GMP documents and peer review for the colleagues

Evaluated and aligned KPI’s for the 13 channel functions in Hyderabad

Responsible for providing Training and mentorship to the new recruits

Trainee & Associate Business Analyst Jan 2006 – Dec 2006

Covansys India Pvt. Ltd., Chennai, India

Developed and managed user requirements

Performed validation activities on an in house CTMS system

Involved in the detailed market research and COE documentation for the NetRegulus project

Participated in the development of beta - module patient diary for the Tuberculosis Research Centre

Developed white papers, business cases & gap analysis documents for various projects

EDUCATIONAL QUALIFICATIONS

Masters in Clinical Research June-2004 – June-2006

ICRI, New Delhi

B.Sc. In Microbiology June-2001 – May-2004

Sophia College Mumbai, Mumbai University, Mumbai

PROFESSIONAL CREDENTIALS

Certified in 21 CFR Part 11

Certified in Project Management

Emotional Intelligence –Workshop

Certified in MS office 2007

Team Management in Crisis Situation

Dale Carnegie Workshop on Communication for Managers

Attended 1 month Intensive Training for Trial Managers in Basel, Switzerland, 2007

Certified in Train the Trainer Course- Internal Development course by offered by Novartis

PERSONAL DETAILS

Date of Birth: 6th January 1983, Nationality: Indian, Gender: Female, Marital Status: Married, Driving License: No, Languages Proficiency: English & Hindi

References available on request

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