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Rebecca Shirk is listed as Principal Regulatory Writer at Synchrogenix, a Certara company at Synchrogenix, a Certara company, based in Malvern, Pennsylvania, United States. AeroLeads shows a work email signal at synchrogenix.com and a matched LinkedIn profile for Rebecca Shirk.
Rebecca Shirk previously worked as Principal Regulatory Writer at Synchrogenix, A Certara Company and Senior Research Scientist II at Wyeth Research. Rebecca Shirk holds Postdoctoral Studies from Wake Forest University School Of Medicine.
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AeroLeads found 1 current-domain work email signal for Rebecca Shirk. Compare company email patterns before reaching out.
Dr. Shirk is a Principal Regulatory Writer, with 10 years of regulatory writing experience of nonclinical and clinical regulatory documents for small-molecule drugs and biologics across multiple therapeutic areas. In addition, she has 8 years of experience in pharmaceutical research and development and 13 years of experience in clinical laboratory science as a board-certified medical technologist. She leads nonclinical writing teams for INDs, NDAs, and BLAs, serving as a liaison between writers, client, and management; maintaining collaborative and proactive communications with both client and internal team; and providing guidance and critical reviews.She develops, manages, and authors regulatory documents according to regulatory guidelines and ensures adherence to high quality standards, timeline, and budget, while managing multiple writing projects. She has extensive writing experience with CTD modules 2.4 and 2.6 (nonclinical overview and nonclinical summaries), modules 2.7.1 and 2.7.2 (summaries of biopharmaceutic studies and clinical pharmacology), and investigator brochures.
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A career timeline built from the work history available for this profile.
Radnor, Pennsylvania, US
Leads nonclinical writing teams for regulatory submissions. Writes, edits, and reviews clinical and nonclinical submission level documents for INDs, NDAs, BLAs, and MAAs, working with client at the content and project management levels.
New York, New York, US
Drug discovery research in big pharma; environment in cardiovascular disease. Experience includes: Biology team leader for anticoagulant program and team member for four additional programs in heart failure and thrombosis.
New York, New York, US
Drug discovery research in Women's Health. Evaluated effects of sex hormones & drug candidates on hemostasis parameters in animal models.
Researched structure and function of coagulation factor XI and the interaction with platelets. (Advisor: Peter N. Walsh, M.D., Ph.D.)
Chapel Hill, North Carolina, US
Medical Technologist in Clinical Coaguation Laboratory: Developed and implemented new clinical coagulation assays, evaluated new instrumentation and reagents, lab supervision duties (1987-1989); part-time bench tech (1983-1987 & 1989-1996) running standard assays in STAT lab setting.
US
Performed bacterial culture, identification, and antimicrobial susceptibility testing. Taught students at the bench.
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Matthew Brougham
Colleague at Synchrogenix, A Certara CompanyOttawa, Ontario, Canada, Canada
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Holly Lusk
Colleague at Synchrogenix, A Certara CompanyWindsor, Colorado, United States, United States
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Holly Dierkers
Colleague at Synchrogenix, A Certara CompanyCincinnati Metropolitan Area, United States, United States
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Timothy Verret
Colleague at Synchrogenix, A Certara CompanyAustin, Texas, United States, United States
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Thomas Moyer
Colleague at Synchrogenix, A Certara CompanyEphrata, Pennsylvania, United States, United States
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Michael Miner, M.B.A.
Colleague at Synchrogenix, A Certara CompanyCharleston, South Carolina, United States, United States
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Susmitha Raja
Colleague at Synchrogenix, A Certara CompanyKurnool, Andhra Pradesh, India, India
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Keping Li
Colleague at Synchrogenix, A Certara CompanyWest Newton, Massachusetts, United States, United States
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PR
Pathmanaban Raj
Colleague at Synchrogenix, A Certara CompanyNew York City Metropolitan Area, United States, United States
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RB
Rob Barlow
Colleague at Synchrogenix, A Certara CompanyGreater Philadelphia, United States, United States
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Quick answers generated from the profile data available on this page.
Rebecca Shirk works for Synchrogenix, a Certara company.
Rebecca Shirk is listed as Principal Regulatory Writer at Synchrogenix, a Certara company at Synchrogenix, a Certara company.
AeroLeads has found 1 work email signal at @synchrogenix.com for Rebecca Shirk at Synchrogenix, a Certara company.
Rebecca Shirk is based in Malvern, Pennsylvania, United States while working with Synchrogenix, a Certara company.
Rebecca Shirk has worked for Synchrogenix, A Certara Company, Wyeth Research, Sol Sherry Thrombosis Research Center (Temple University School Of Medicine), Unc Hospitals, and Duke University Medical Center.
Rebecca Shirk's colleagues at Synchrogenix, a Certara company include Matthew Brougham, Holly Lusk, Holly Dierkers, Timothy Verret, and Thomas Moyer.
You can use AeroLeads to view verified contact signals for Rebecca Shirk at Synchrogenix, a Certara company, including work email, phone, and LinkedIn data when available.
Rebecca Shirk holds Postdoctoral Studies from Wake Forest University School Of Medicine.
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