Allison Lehtinen Rac
Detail-oriented scientist with proven track record of effectiveness in leading regulatory affairs and research operations to support client... | Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States
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Allison Lehtinen Rac’s Emails al****@pf****.com
Allison Lehtinen Rac’s Phone Numbers No phone number available.
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Allison Lehtinen Rac’s Location Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States
Allison Lehtinen Rac’s Expertise Detail-oriented scientist with proven track record of effectiveness in leading regulatory affairs and research operations to support client goals for product marketing. Offers thorough command of all regulations and protocols governing project lifecycles from early phase coordination through postmarketing license maintenance. Focused and efficient in facilitating execution of deadline driven project applications and reports. Promotes a cooperative workplace environment by maintaining clear and supportive dialogues across organizational levels. Able to interpret and communicate highly technical medical data to all levels of audiences verbally and in writing. Specialties: • Clinical Trial Regulatory Support and Review • FDA, EMEA, and ICH Regulations • Full-Lifecycle R&D Oversight, including Postmarketing • GLP, GMP, and GCP guidelines • Medical Writing and Editing • Project Documentation and Submission • Project Management • Regulatory Compliance Initiatives • Staff Training, Mentoring, and Supervision • Strategic Planning and Implementation
Allison Lehtinen Rac’s Current Industry Pfizer
Allison
Lehtinen Rac’s Prior Industry
Wake Forest School Of Medicine
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Cato Research
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Biogen
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Pfizer
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Work Experience
Pfizer
Director, Global Regulatory Sciences, Vaccines CMC
Tue Sep 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Pfizer
Senior Manager, Global CMC Regulatory Affairs, Vaccines
Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Sep 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Sr. Manager, CMC Regulatory Affairs
Sun Feb 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Biogen
Manager, CMC Regulatory Affairs
Wed May 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Feb 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Cato Research
Project Manager
Wed Sep 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Cato Research
Assistant Project Manager
Thu Jan 01 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Sep 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time)
Cato Research
Regulatory Scientist
Sun Jun 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Apr 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Wake Forest School Of Medicine
Postdoctoral Research Associate
Fri Apr 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jun 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Allison Lehtinen Rac Email Addresses
FAQ About Allison Lehtinen Rac
-
Allison Lehtinen Rac is located at
Raleigh-Durham-Chapel Hill Area, Raleigh-Durham-Chapel Hill Area, United States -
Allison Lehtinen Rac is a
Detail-oriented scientist with proven track record of effectiveness in leading regulatory affairs and research operations to support client goals for product marketing. Offers thorough command of all regulations and protocols governing project lifecycles from early phase coordination through postmarketing license maintenance. Focused and efficient in facilitating execution of deadline driven project applications and reports. Promotes a cooperative workplace environment by maintaining clear and supportive dialogues across organizational levels. Able to interpret and communicate highly technical medical data to all levels of audiences verbally and in writing. Specialties: • Clinical Trial Regulatory Support and Review • FDA, EMEA, and ICH Regulations • Full-Lifecycle R&D Oversight, including Postmarketing • GLP, GMP, and GCP guidelines • Medical Writing and Editing • Project Documentation and Submission • Project Management • Regulatory Compliance Initiatives • Staff Training, Mentoring, and Supervision • Strategic Planning and Implementation Pfizer -
Allison Lehtinen Rac currently works in the
Pfizer -
Allison Lehtinen Rac specializes in
Detail-oriented scientist with proven track record of effectiveness in leading regulatory affairs and research operations to support client goals for product marketing. Offers thorough command of all regulations and protocols governing project lifecycles from early phase coordination through postmarketing license maintenance. Focused and efficient in facilitating execution of deadline driven project applications and reports. Promotes a cooperative workplace environment by maintaining clear and supportive dialogues across organizational levels. Able to interpret and communicate highly technical medical data to all levels of audiences verbally and in writing. Specialties: • Clinical Trial Regulatory Support and Review • FDA, EMEA, and ICH Regulations • Full-Lifecycle R&D Oversight, including Postmarketing • GLP, GMP, and GCP guidelines • Medical Writing and Editing • Project Documentation and Submission • Project Management • Regulatory Compliance Initiatives • Staff Training, Mentoring, and Supervision • Strategic Planning and Implementation -
Allison Lehtinen Rac speaks the following languages:
No languages available. -
Allison Lehtinen Rac has prior experience in the following industries:
Pfizer , Biogen , Biogen , Cato Research , Cato Research , Cato Research , Wake Forest School Of Medicine -
Allison Lehtinen Rac has the following professional experience:
Pfizer , Pfizer , Biogen , Biogen , Cato Research , Cato Research , Cato Research , Wake Forest School Of Medicine . -
You can view Allison Lehtinen Rac’s
LinkedIn profile at LinkedIn URL. -
Allison Lehtinen Rac’s work email addresses are
[email protected] . -
Allison Lehtinen Rac works at
Pfizer
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