Information Technology (IT) and Telecommunications professional with over 25-years of experience and a strong record of implementing quality-based business processes and requirements along with the technical requirements necessary to support the launch of new products and applications through their full life cycle – Project Management Professional experienced in managing an IT Portfolio with projects including system implementations & upgrades, product development & launches, software development & implementation as well as systems integrations.  Subject Matter Expert skilled in identifying business risks,…

• Over twenty years of statistical, project and business management experience in the pharmaceutical industry.• Hands-on experience as a statistical programmer and analyst in data manipulation and statistical reporting.• Experienced in CDISC and managing projects for SDTM and ADaM as well as CSRs.• Advanced degrees and training in statistics, economics, and demography including epidemiology.

Leadership of Health Economics and Outcomes Research (HEOR) projects in oncology, immuno-oncology, CNS, hematology, biologicals for asthma and rheumatoid arthritis, endocrinology, vaccines, pain, and inflammation therapies and cardiovascular and respiratory diseases. Strategic thinking, problem-solving and decision-making skills. Successful collaboration with subject matter experts, as well as internal and external stakeholders. Expertise in leveraging outcomes data in the appropriate clinical context.Program direction from initial strategy development through protocol design, PRO selection, publication and production of educational materials. Strong interpersonal skills, multicultural…

Experienced clinical dataarchitect with over 18 years of experience with focus on product innovation, architecture and data management.  Passionate about increasing efficiency through data analytics.  Record of improving efficiency and productivity through automation and sound data architecture. Posses the following core competencies:

• Global Partnership

• Project Management

• Data Profiling

•Strategic Planning

• ETL Development

• Program Oversight

• Client Success

• Data Architecture

With over a decade of experience in the life science industry, spanning devices, drugs, veterinary products, and diagnostics, I have gained a rare perspective on what it takes to bring an innovative product from concept to commercialization. I specialize in guiding early-stage companies as they navigate fundraising and execution on milestones in an increasingly complex regulatory environment. I am also well-positioned to assist companies of all stages and sizes needing extra hands on deck for specific projects, having the experience,…

An experienced professional with a broad background in data management, project management, and IT-related Stuff.

Blends detailed understanding of the clinical trial process and regulatory standards with expertise in resource management, data management, and process/technical developments to advance data management operations.  Hires and cultivates talent to offer discrete handing of sensitive information for fast-turnaround assignments.  Mentors team members in best practices, SOPs, industry standards, and federal, state, and local regulations.

I focus on helping companies maximize investments and develop their clinical portfolio through utilization of the optimal outsourced model. I offer strategic and transactional support including:

CRO/vendor selections;

Contract and budget negotiations;

Change Order management;

Financial oversight;

CRO Partnership selection and negotiation;

Governance development support services, including CRO/vendor relations management; and,

Gap analysis including audit ready procurement/supplier selection documentation.

My passion is bringing precise formatting and order to document messes and chaos.

I have been formatting and troubleshooting documents as well as creating templates in Word for over 20 years.  I have worked primarily on regulatory submission documents (documents from pharmaceutical and biotech companies who submit their documents to the Food & Drug Administration or to other Health Authorities throughout the world) but have worked with numerous types of eCTD templates for…

·         Strong experience on LAN, WirelessLAN, switching

·         IP addressing/configuration (WIN/LINUX)

·         Configure and manage firewall Sonicwall E5600, FortiGate 60, Smoothwall, IPCop, PFsense and Packetfence

·         Install/Configure and Maintain windows 2000/2003/2008 Active Directory, DNS and DHCP

·         Linux DNS/Web Server Configuration

·         Install OS MS Windows 2000/XP/Vista/7/8/10

·         Install Linux Mint, Ubuntu,…

Lead LifeSciHub through start up phase to the hockey stick and beyond. Build platform and consultant support back end administration workflow through acquired resources and technologies.  Creating funding and strategic growth plans.  Execute.

Highly skilled, detail-oriented GxP professional with 20+ years in technology-driven work settings. Expert planning and reporting skills, ability to see big picture, well-organized, focused on results, capable of managing multiple projects, excellent time and self-management.  Clinical experience with materials, manufacturing, filing and quality control.

 Demonstrated experience in systems and manufacturing auditing, project and process management, inventory, reporting, audits and systems operations.

Strong leadership in reporting/planning, operations/production, auditing, Root Cause Analysis and implementation of corrective/preventive action…

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Dynamic, forward-thinking pharmacovigilance leader with a unique blend of “big pharma” and small biotech experience. Experience in pharmacovigilance activities from development through regulatory approval, including post approval regulatory commitments, i.e., global registry studies for marketed products, REMS programs. Comprehensive knowledge of Pharmaceutical Operations, Risk Management, Signal Detection and FDA Advisory Committee meetings. Broad range of experience including small molecules, biologicals, and orphan drug products for rare diseases.

CORE COMPETENCIES

 Signal Detection and Evaluation

 Pharmacovigilance Operations

 Effective Communication…

Dedicated Clinical Safety & PV contractor and consultant with almost 20 years of pre- and post-market product safety

life-cycle development, research, and surveillance experience. I hold a Masters of Science in Clinical Research, Health

Evaluation Sciences from the University of Virginia, & a Bachelors degree in Psychology, with dual concentrations in

Neuro and Clinical, from Hollins University. Previous professional experience prior to undergraduate and graduate

program completion includes 8 years of full and part-time positions in the health and science…

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Experience with end to end manufacturing, clinical, and post marketing system development, management, and oversight, encompassing drug, device, and combination products. Providing leadership guidance and implementation methodology for Clinical Safety, Data Migration, Document Management, Product Complaint, Clinical Trial Monitoring, Regulatory Submissions, Data Mining, Signal Detection, Safety Surveillance, Corporate Compliance, Pharmacovigilance reporting and Training. Involved in preparation and filing of Investigational New Drug (IND) and New Drug Applications (NDA), Biologics License Application…

Widler & Schiemann AG can provide you with innovative, creative and cost-effective answers to your questions and needs in the areas of Clinical Quality Management. With our vast experience and extensive network in the industry and the regulators we are uniquely positioned to identify and provide the best solutions for you.

Over 10 years in web development field

Experience with designing manufacturing and packaging solutions for new and

existing product lines

Understanding of labeling, artwork, and packaging design options

Deep understanding of serialization, track and trace, and regulatory

requirements regarding supply chain traceability

Knowledgeable in creating specifications for packaging equipment used for

syringes, ampules, vials, bottles, blisters, cartons, cases, pallets and EPCIS, ERP,

MES interfacing

Proven track record of managing and maturing project teams

Thorough knowledge of packaging equipment and details of internal operation

Senior Clinical Trials Professional with over 9 years of experience in supply chain, clinical operations, and

budgets. Results-oriented team player, versed in all aspects of clinical trial lifecycle, including budgeting,

contract negotiations, inventory, forecasting, predictive supply, and vendor management. Adept at using

computer tools and models for analysis, tracking, and creating patient-facing materials. Clear communicator

with high level of integrity, focused on process improvement, best practices, and continued growth.