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Project Manager Quality Assurance

Location:
Creedmoor, NC
Posted:
October 29, 2012

Contact this candidate

Resume:

Karen Barstow

Email: abo75h@r.postjobfree.com

Address: **** ***** ****

City: Creedmoor

State: NC

Zip: 27522

Country: USA

Phone: 919-***-****

Skill Level: Management

Salary Range: 90

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Karen Lilford Barstow, Ph.D.

2004 Hayes Road

Creedmoor, NC 27522

919-***-****

Email: abo75h@r.postjobfree.com

Summary of Qualifications

aa Excellent communication skills, both written and verbal

aa Creative problem solving abilities

aa Effective presentation and facilitation skills

aa Strong management skills and effective allocation of available resources

aa Ability to train, develop and encourage young professionals

aa Critical analysis of statistical information

Experience

Siemens Healthcare Diagnostics Tarrytown, NY

Project Manager / Technical Writer 07/2012-Present

Note: Change in responsibilities due to a re-location to North Carolina

aa Manage all reagent labeling deliverables for assigned projects

aa Establish project priorities and schedules for all reagent labeling deliverables

aa Work with other functions such as regulatory affairs, service, marketing, and clinical affairs to research, evaluate, and organize required technical information

aa Write reagent instructions for use ensuring technical accuracy and compliance to regulatory requirements for US, European, and Asian markets

aa Manage cross-functional reviews of all project deliverables

aa Schedule department and interdepartmental meetings

aa Coordinated with graphic personnel to plan illustrations and reagent labeling

aa Plan, schedule, and manage translations of instructions for use

aa Represent the product labeling group on business-initiative projects

Siemens Healthcare Diagnostics Tarrytown, NY

Head Reagent Documentation and Product Labeling 01/2008-06/2012

aa Manage reagent document and product labeling group which consists of twenty employees

aa Responsible for all reagent documentation, reagent labeling, and system labeling throughout the product development cycle

aa Ensure that documentation and labeling meet regulatory requirements for the United States, the European Community, Japan, and other countries

aa Monitor progress of all labeling project to support new products, revisions to existing projects, and departmental initiatives

aa Schedule departmental meetings

aa Provide guidance, training, and mentoring for the reagent document and product labeling group

aa Complete performance reviews, development planning, and identify leadership potential within the group

aa Coordinate with other functions including regulatory affairs, quality assurance, clinical trials, software, and research and development to assess labeling and resource requirements

aa Work with the translation coordinator to plan and schedule translation of documentation and labeling

Bayer Diagnostics/Siemens Healthcare Diagnostics Tarrytown, NY

Information Design Team Leader 03/2005-12/2007

aa Managed information design responsibilities for the molecular testing products

aa Established project priorities and schedules for information design deliverables

aa Managed resources assigned to the molecular testing documentation and labeling projects

aa Worked with other functions such as software, service, marketing, and regulatory affairs to research, evaluate, and organize required technical information

aa Scheduled department and interdepartmental meetings

aa Coordinated with graphic personnel to plan illustrations and reagent labeling

aa Worked with the translation coordinator to plan and schedule translation of customer documentation

aa Developed and wrote customer and service instructions for use

Harte-Hanks Interactive Lake Katrine, NY

Medical Director /Medical Writer 09/2003-03/2005

aa Developed and wrote scientific content for pharmaceutical Web sites

aa Reviewed all content for medical accuracy

aa Ensured FDA compliance of all content

aa Met with regulatory committees to review content

aa Worked with clients to achieve overall brand messaging

aa Responded to requests for proposals

aa Showcased Harte-Hanks capabilities to prospective clients

Education

University of Vermont College of Medicine Burlington, VT

Post-Doctoral Associate 01/2001-09/2003

Boston University Medical School Boston, MA

PhD in Pharmacology 2001

Boston University Medical School Boston, MA

MA in Medical Sciences 1996

Boston University Boston, MA

BA in Psychology 1992

Karen Lilford Barstow

Original Reports

1. Merriam LM, Barstow KL, Parsons RL. Pituitary adenylate cyclase-activating polypeptide enhances the hyperpolarization-activated nonselective cationic conductance, Ih, in dissociated guinea pig intracardiac neurons. Regul. Peptide 2004; 123(1-3):123-133.

2. Barstow KL, Locknar SA, Merriam LM, Parsons RL. The modulation of action potential generation by calcium-induced calcium release is enhanced by mitochondrial inhibitors in mudpuppy parasympathetic neurons. Neuroscience 2004; 124(2): 327-339.

3. Locknar SA, Barstow KL, Tompkins JD, Merriam LA, Parsons RL. Calcium-induced calcium release regulates action potential generation in guinea-pig sympathetic neurones. J. Neurophysiol. 2004; 555(Pt 3): 627-635.

4. Parsons RL, Barstow KL, Scornik FS. Spontaneous miniature hyperpolarizations affect threshold for action potential generation in mudpuppy cardiac neurons. J Neurophysiol. 2002; 88(3): 1119-27.

5. Falkenburger BH, Barstow KL, Mintz IM. Dendrodendritic inhibition through reversal of dopamine transport. Science 2001; 293: 2465-2470

6. Barstow Lilford K. Subthalamic control of dopamine release in the substantia nigra. Thesis for Ph.D. in Pharmacology, Boston University School of Medicine. January, 2001.

7. Barstow Lilford K. Opioid induced sensitization. Thesis for Masteraaas Degree in Medical sciences, Boston University School of Medicine. May, 1996.

8. Tomera JF, Lilford K, Friend KD, Kukulka SP, Harakal C. Calcium accumulation in experimental hypertension. Food Chem Toxicol. 1995;

33(7): 579-90.

9. Tomera JF, Lilford K, Harakal C. Multiple linear regression analysis of hypertrophy, calcium and cadmium in hypertensive and non-hypertensive states.

Food Chem Toxicol. 1995; 33(6): 529-35.

10. Tomera JF, Lilford K. Co-modulation between acetylcholinesterase and cyclic nucleotide signal transduction systems in burn trauma. Methods Find Exp Clin Pharmacol. 1995;17(2): 89-105.

11. Tomera JF, Lilford K. Indirect talk of signaling systems in endotoxicosis: cross-talk alternatives. Methods Find Exp Clin Pharmacol. 1994;16(10): 697-716.

12. Tomera JF, Lilford K, Kukulka SP. Polyinositol interrelationships in skeletal muscle under the duress of burn trauma. Burns. 1994;20(3): 212-9.

13. Tomera JF, Lilford K. Multiple stepwise regression analysis of physiologic

tension and secondary messengers in chronic burn trauma. Methods Find Exp Clin Pharmacol. 1994;16(4): 235-46.

14. Tomera JF, Lilford K. Multivariate and vectorial analysis of pharmacological signaling: diaphragm inositol 1,4,5-triphosphate under the duress of burn trauma. Burns. 1994;20(2): 136-45.

15. Tomera JF, Kukulka SP, Lilford K, Martyn JA. E. coli endotoxin affinity at the nicotinic2 receptor: receptor theory revisited, ilumina nostros occulae. Methods Find Exp Clin Pharmacol. 1994;16(3): 191-201.

16. Tomera JF, Lilford K, Kukulka SP, Friend KD, Harakal C. Divalent cations in hypertension with implications to heart disease: calcium, cadmium interactions. Methods Find Exp Clin Pharmacol. 1994;16(2): 97-107.

17. Tomera JF, Lilford K, Kukulka SP. Dysfunctional metabolism induced by the systemic effects of burn trauma: the role of rates of polyinositol and glycerophosphate formation in diaphragm. J Burn Care Rehabil. 1993;

14(6): 639-52.

18. Tomera JF, Lilford K. Multivariate influence of polyinositols on IP3 in diaphragm: individually applied matrix and vectorial analysis of trauma from small and large body surface area burn groups. Methods Find Exp Clin Pharmacol. 1993;15(8): 497-507.

19. Tomera JF, Kukulka SP, Lilford K. Myocardial [3H]polyinositol phosphates and their response to burn trauma. Burns. 1993;19(5): 379-86.

20. Tomera JF, Lilford K. Calcium and skeletal muscle: a multiple regression on signal transduction mechanisms in burn trauma. Methods Find Exp Clin Pharmacol. 1993;15(7): 471-82.

21. Tomera JF, Lilford K. Multivariate influence of inositol phosphates on cAMP: interrelationships between signal transduction mechanisms in burn trauma.

Burns. 1993;19(4): 313-9.

22. Tomera JF, Lilford K, Martyn JA. Diaphragm acetylcholinesterase multimeric forms in mice in response to burn trauma. J Burn Care Rehabil. 1993;

14(4): 406-19.

23. Tomera JF, Lilford K. The alpha study: multiple regression of the inositol 1,4,5-triphosphate signal transduction mechanism in burn trauma. Methods Find Exp Clin Pharmacol. 1993;15(6): 395-406.

24. Tomera JF, Lilford K. Multiple regression of skeletal muscle tension on inositol phosphates: cross-talk between signal transduction mechanisms in burn trauma. Methods Find Exp Clin Pharmacol. 1993;15(5): 255-65.

25. Tomera JF, Lilford K, Kukulka SP. Changes in diaphragm polyinositol phosphates caused by a large body surface area burn. Burns. 1993;

19(1): 35-42.

26. Tomera JF, Kukulka SP, Lilford K. Cross-talk of second messengers during the systemic trauma response following burn injury: how, when, and where.

Circ Shock. 1993;39(2): 128-38.

27. Tomera JF, Kukulka SP, Lilford K. Formation of gastrocnemius [3H]polyinositol phosphates in response to burn trauma. Burns. 1992;

18(5): 381-6.

28. Tomera JF, Friend KD, Kukulka SP, Lilford K. Modification of calcium flux of twitch skeletal muscle in mice subjected to 20% body surface area burn. J Burn Care Rehabil. 1992;13(5): 546-55.



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