Rebekah Schulz, Phd, Pmp Email and Phone Number
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Rebekah Schulz, Phd, Pmp personal email
Ph.D. and PMP certified professional with 5 years of experience in project management and regulatory authoring for Phase I - IV clinical trials. Experience includes, but is not limited to:• Managing timelines and budgets for over 60 small and large drug development projects• Acting as US agent to more than 10 FDA applications• Coordinating over 5 successfully submitted IND applications• Authoring of regulatory submission documents for both IND and BLA applications
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Senior Regulatory Affairs ConsultantParexel May 2024 - PresentDurham, North Carolina, Us• Responsible for managing teams of CMC, NC, and Clinical professionals to produce high quality regulatory deliverables • Ensured successful submission of regulatory packages through development and adherence to global regulatory strategy • Demonstrated leadership and mentorship through training team members on the adoption of the Veeva Vault system
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Regulatory Affairs ConsultantParexel Jul 2022 - May 2024Durham, North Carolina, Us• Strong communication skills and attention to detail in authoring and managing the submission of INDs, IMPDs, sBLAs, and regulatory communication• Proven collaboration skills through creating and maintaining relationships with regulatory authorities as US agent
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Senior Regulatory Affairs AssociateParexel Sep 2021 - Jul 2022Durham, North Carolina, Us•Robust project management experience including leading high priority scopes under tight timelines and budgets•Demonstrated verbal communication skills through engaging and establishing credibility with clients, which led to earning repeat business
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Specialist, Project Management And Clinical PharmacologyNuventra Pharma Sciences May 2020 - Jul 2021Research Triangle Park, Nc, Us• Manage project scope, budgets, timelines, and personnel/resource allocation to ensure functional deliverables are supplied on time, on budget and according to quality standards• Follow up on critical action items and alert project team of potential roadblocks or delays to provide resolution to issues identified on projects• Assist with the preparation, review, QC, and formatting of clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packets, and other clinical and regulatory documents -
Ph.D. CandidateUniversity Of North Carolina At Chapel Hill Aug 2015 - May 2020Chapel Hill, Nc, UsAdvisor: Jenny Ting• Thesis title: The effect of STING activation on the innate and adaptive immune response• Honed critical thinking and analytical skills through planning and completing three research projects while effectively communicating with team members• Managed competing demands and multiple scientific research projects by performing tasks simultaneously, while still completing overall objectives• Developed cross-organizational collaborative skills though working in a team environment with multi-disciplinary collaborators on drug development-related projects -
Regulatory Affairs InternCato Sms Oct 2019 - Nov 2019Cary, North Carolina, Us• Authored and reviewed pieces of clinical reports, including INDs/BLAs, for sponsors• Observed meetings with sponsors to determine direction of projects• Contributed to weekly lectures covering key aspects of clinical studies, including drug and device approval proceduresPrimary author of the following documents:• Poster presentations summarizing nonclinical and clinical studies for a national conference• Patient narrativesAuthored sections of the following documents:• Investigational New Drug (IND) Application• Biologics License Application (BLA)• Periodic Safety Update Reports (PSUR) -
Undergraduate ResearcherVirginia Tech Aug 2013 - May 2015Blacksburg, Va, UsAdvisor: Bin Xu, Ph.D. • Authored a scientific review article, demonstrating a strong ability to summarizes animal and clinical studies, and draws conclusions• Demonstrated ability to reduce complex scientific data to it essence in tabular or summary form -
Research And Development InternTechlab, Inc. May 2014 - Aug 2014Blacksburg, Va, Us• Gained product development experience for an FDA regulated medical device • Participated on a team to develop a “quick” intestinal inflammation diagnostic test -
Undergraduate ResearcherVirginia Tech Jan 2012 - May 2013Blacksburg, Va, UsAdvisor: Chenggang Tao• Characterized the surface morphology of graphene and copper by scanning tunneling microscopy• Investigated metallofullerenes application as a safe MRI contrast agent
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Intern- Education Program AssistantUsaid Jun 2010 - Aug 2010Washington, District Of Columbia, Us• Cataloged and labeled relevant education project information and documented project goals and deliverables -
Intern- Assistant Medical LibrarianUs Navy Medical Research Unit Number 3 Jun 2009 - Aug 2009• Cataloged previous medical research (internal and external) and categorized public research
Rebekah Schulz, Phd, Pmp Skills
Rebekah Schulz, Phd, Pmp Education Details
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University Of North Carolina At Chapel HillGenetics And Molecular Biology -
Virginia TechNanoscience
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Westfield High SchoolHigh School Diploma
Frequently Asked Questions about Rebekah Schulz, Phd, Pmp
What company does Rebekah Schulz, Phd, Pmp work for?
Rebekah Schulz, Phd, Pmp works for Parexel
What is Rebekah Schulz, Phd, Pmp's role at the current company?
Rebekah Schulz, Phd, Pmp's current role is Senior Regulatory Affairs Consultant at Parexel.
What is Rebekah Schulz, Phd, Pmp's email address?
Rebekah Schulz, Phd, Pmp's email address is re****@****dex.com
What schools did Rebekah Schulz, Phd, Pmp attend?
Rebekah Schulz, Phd, Pmp attended University Of North Carolina At Chapel Hill, Virginia Tech, Westfield High School.
What skills is Rebekah Schulz, Phd, Pmp known for?
Rebekah Schulz, Phd, Pmp has skills like Cancer Research, Clinical Trials, Immunologist, Personnel Management, Timeline Management, Clinical Pharmacology, Microsoft Powerpoint, Clinical Research, Business Development, Communication, Regulatory Affairs, Client Liaison.
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