July **, ****

JOHN H. WOJCIK

*** ***** ****** 610-***-****: home

Glenolden, PA 19036 acvufm@r.postjobfree.com 610-***-****: cell

www.mycareerhighlights.com/johnwojcik

REGULATORY OPERATIONS MANAGEMENT/SUBMISSIONS PLANNING/PUBLISHING

Strategic and Tactical Pharmaceutical Management roles driving the regulatory submissions environment with expertise in maintaining a constant awareness of ever changing code of federal regulations and various BLA and NDA submission guidance. Managed a yearly $500K capital budget and built an electronic submissions group from the ground up exploring novel ways and various platforms for BLA and NDA submissions before the advent of FDA electronic submission. Researched and purchased cutting edge technology to minimize the use of human capital and resources. Manage two distinct operational groups, a project planning group and a major submissions publishing group of 10 planners and publishers and 2 managers Directed major submissions of multiple vaccines and drug products where projects overlapped resulting in a juggling of resources and creative solutions to maintain project completion dates. Delivered to fruition several major vaccine and drug product submissions ahead of schedule resulting in over $1M in projected sales for each day ahead of scheduled submission date.

CORE COMPETENCIES

Regulatory Expert Business Process Engineering/Documenting Procurement

Strategic Analysis/Planning Program/Project Planning/Management Software Development

Budget Planning/Analysis Systems Validation/Implementation Training/Mentoring

Technology Integration Vaccine/Drug Submission Planning Client Communication

Internal Consulting Drug Discovery/Development Processes Systems Analysis

PROFESSIONAL EXPERIENCE

Associate Director, Global Regulatory Services June 2013 – January 2015

Accenture, Wayne PA.

Responsible for Electronic Regulatory Publishing projects and related activities, including managing personnel time budgets, personnel issues, and client relationships.

Report on all aspects of a project. Build new client relationships and create proposals.

Give presentations, both to the client as well as internally at Accenture. Travel to client sites to oversee team activities and work with the client. Manage people both individually and in team environments.

Recognize new client opportunities and work with Directors/Sales to develop and pursue new service offerings.

Major Achievements

Supplied and managed resources in a staff augmentation capacity across major pharmaceutical companies supporting multiple new drug submissions and resulting maintenance for several NDA approvals.

Successfully managed several pilot engagements with major pharmaceutical companies that resulted in long term submission publishing contracts.

Global Submissions Leader (May 2011-June 2013)

Bayer Pharmaceuticals, Montville NJ.

Manages all operational activities associated with compilation, publishing and distribution of submission dossiers for large, complex and long term projects submitted to Health Authorities worldwide.

Compiles global submission dossiers, identifying and recommending approaches, which fulfill the

requirements of global health authorities plus the business needs and objectives of key Bayer stakeholders

worldwide.

Advises submissions staff and trains multi-discipline global authors in building quality submission

documents including the use of specific software tools and processes.

As a Submission team project manager responsible for monitoring submission tasks and team deliverables.

Major Achievements

Submitted 2 Women’s Health Care Product NDAs one week ahead of the scheduled submission dates of December 16, 2011 and June 23, 2012.

Also submitted an Oncology NDA that received an approval at the 5th month of a 6 month priority review on September 27, 2012.

Director, Regulatory Operations (August2010-November 2010)

NPS Pharmaceuticals, Bedminster NJ

Oversight of the preparation, coordination, and submission of Regulatory documents as well as policy review and implementation of technical regulatory activity.

Major Achievements

Assisted in design, validation, and user acceptance testing while establishing new EDMS system (Next Docs) to production status within 2 months

Established ESG (Electronic Submissions Gateway) for all ongoing and future submissions.

Directed and assisted in compilation and publishing submissions in both paper and electronic IND and CTA amendments.

Established eCTD viewer (Rosetta Phoenix) as Regulatory default application viewer.

GLAXOSMITHKLINE PHARMACEUTICALS, Philadelphia, PA 1988-2009

Global Pharmaceutical & Healthcare Company with revenues of $47B and over 100K employees

Director, Vaccines Major Submission Planning & Publishing (2006-2009)

Recruited by the FDA Director of Electronic Submissions, to author e-IND Vaccine guidance by providing fully functional and complete example submissions, giving GlaxoSmithKline an advantage in submitting electronic applications and solidifying our relationship with the FDA Division of Electronic Submission.

Major Achievements

Directed the submission teams for franchise drug products including Avandia, Paxil, Augmentin, Levitra and Vaccines, driving several submissions to completion months earlier and under budget resulting in increased revenues of up to $50M.

Provided onsite logistical support for over 20 Advisory Committee Meetings.

Spearheaded the development and implementation of cost effective and efficient processes for the publishing of major US Vaccines regulatory submissions.

Consolidated Submission Publishing and Planning Groups into one Vaccines Operations Support Group resulting in a more cohesive group responding to customer needs.

Developed project management planning strategies and operational planning processes to support US Vaccine submission matrix teams

Built and maintained network infrastructure and end user hardware for Submissions Publishing Group when Corporate IT did not support the group at its inception.

GLAXOSMITHKLINE (Cont’d)

Associate Director, Submission Management & Publishing, Regulatory Affairs (2001-2006)

Effectively coordinated multiple projects and global personnel in a complex regulatory environment providing the leadership and process strategies to meet strict submission deadlines.

Major Achievements

Represented company at FDA meetings as the subject matter expert in all operations issues related to eCTD and other Module issues and used expertise to answer FDA queries.

Interacted with global vaccines operations group to maximize resources and data generation and coordinated with operations in Europe to satisfy US, European and International submission needs.

Broadened scope of responsibilities for all GSK therapeutic business (Oncology, Vaccines, Infections, Diseases, Metabolic, and Respiratory)

Expertise includes strategic evaluation and drug submission compilation tools: MS Project, Adobe Acrobat ver7, Compose Plug-ins, Datafarm Plug-ins, Core Dossier, Documentum and Insite Publisher ver2.1.

Assistant Director, Electronic Submissions and Regulatory Communications (1995-2001)

Managed the development of electronic New Drug Applications, paper-based submissions and computer resources for North American Regulatory Affairs Department. Planned, developed and delivered electronic review systems; identifying and implementing hardware and software needs.

Major Achievements

Authored and managed yearly department capital budget ($300-$500K/year).

Delivered electronic submission systems, demonstrations and presentations with additional responsibility for delivery and training for all electronic submission to FDA.

Originated and built Submission Publishing Group from the ground up.

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