HELMUT A. WITTREICH P.O. Box 5373 Somerset, NJ 08875 (908) 873-1001
EXPERIENCE
10/93-Present qdNET, a Division of Scientific Education Associates, Inc., P.O. Box 5373, Somerset, NJ 08875-5373
Consultant/Managing Partner
As a firm specializing in clinical quality assurance, project management and clinical monitoring, our consultants are available on a temporary basis either part time or full time to provide services to the pharmaceutical industry. My responsibilities include furnishing personal consulting services, establishing a business strategy and developing a marketing plan. Our objective is to cultivate and implement a group of knowledgeable and reliable consultants that are easily adaptable to any working environment.
Personal Consulting Assignments:
Project Coordinator, APR Management Group (7/96 - Present)
- Coordinate the timely submission of Annual Progress Reports to the FDA.
- Implement a new APR process.
- Manage the customization, implementation, training and administration of an APR management system.
- This includes project management software tools.
Safety Reporting, Clinical Data Operations (10/93 - 6/96)
- Prepare, review and audit safety tables used in the submission of NDAs, APRs and Safety Updates to the FDA.
- Review, identify and resolve discrepancies between Serious Adverse Events Database and Clinical Project Database.
- Interact with International and Domestic Project Teams to review patient CRFs and resolve identified problems.
- Track projects and provide update reports to all therapeutic teams regarding status of submissions and allocation of resources using project management software.
11/87 - 10/93 IMMUNOBIOLOGY RESEARCH INSTITUTE, a Johnson & Johnson Company, Route 22 East, Annandale, NJ
Assistant Manager, Clinical Documentation and Clinical Supplies
- Develop and implement Clinical Quality Assurance Programs.
- Audit in-house files and clinical investigational sites for GCP compliance.
- Review and track all clinical documents used in the submission of INDs and NDAs.
- Coordinate and track the manufacturing, labeling and distribution of investigational drug.
- Manage a four member Clinical Supplies group.
Clinical Documentation Control Associate, Clinical Development
- Track all regulatory documents submitted by clinical monitors.
- Audit both in-house and clinical study sites.
- Develop and implement Clinical Quality Assurance Programs to ensure compliance with Federal Regulations.
Associate Scientist, Peptide Chemistry Synthesize, purify and characterize immunoregulatory peptides.
3/86 - 11/87 SCHERING-PLOUGH CORPORATION, 60 Orange Street, Bloomfield, NJ
Assistant Scientist II, Natural Products Isolation, Schering Research Division Isolate, purify and identify compounds of pharmacological importance from microbial fermentations.
4/84 - 3/86 WITCO CORPORATION, 100 Bauer Drive, Oakland, NJ
Chemist, Research & Development, Pearsall Chemical Division Organic synthesis, analytical chemistry and process engineering.
Chemist, Technical Service, Allied-Kelite Division Provide technical support to customers from the eastern regional analytical laboratory. Implement developmental projects to determine the scope and application of various products.
EDUCATION
Lehigh University, Bethlehem, Pennsylvania Bachelor of Science degree, October 1983 Major: Biochemistry
PROFESSIONAL AFFILIATIONS
American Chemical Society, Drug Information Association, American Peptide Society, Project Management Institute, Associates of Clinical Pharmacology.
AWARDS
Immunobiology Research Institute - 1989 Special Recognition Award
REFERENCES
Available upon request.