WachholzB CV
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WachholzB CV

Brad Wachholz
45 Constitution Drive, Southborough, MA 01772
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SUMMARY OF QUALIFICATIONS
7+ years experience working in an office environment in administrative support and independent project capacities as well as experience supporting in-house counsel with Confidentiality Agreement processing, management, and general tasks; Bachelor�s degree in Legal Studies as well as a paralegal certificate with a 3.7GPA; Proficiency with Clio, PACER, and e-filing. Familiarity with GCP, regulatory documents and requirements, FDA submissions, and handling of service level contracts as well as Confidentiality Agreements and QC of Trial Master Files; Proven ability to act in a synergistic capacity with multiple departments in order to achieve assigned goals. Full experience includes multiple internships working directly for upper level executives in both project management and legal departments in the Biotechnology field; Strong attention to detail, problem solving, time management and computer skills (Microsoft Office suite, eTMF, Electronic Data Systems).

PROFESSIONAL EXPERIENCE

A2O Regulatory Partners, Inc. August 2017 � Present
Legal Affairs Associate (Part-Time)
� Point of contact and negotiation for all incoming consulting contracts, management of contracts database and renewal timelines.
� Proofing and redlining of consulting contracts.
� Management of Non-Disclosure Agreements.


UniQure, Lexington, MA, USA August 2016 � October 2016
Quality Associate II (Contract)
� Performed an in-depth audit of all controlled documentation and training files stretching back to 2014 and proposed new best practices as well as SOP revisions to streamline the process in an extensive Audit Report.
� Manage QADC (Quality Assurance � Document Control) Archive Room and maintain proper organization of Controlled Documents
� Responsible for archiving, scanning, and tracking documents
� Ensure appropriate version of Effective Document(s) are readily accessible in electronic and/or hard copy form.
� Maintain departments shared mailbox by assuring tasks are completed on a timely manner.
� Coordinate and track the periodic review of SOP to ensure timely completion of reviews and revisions
� Maintain tracking of Training records, assignments and filing.
� Provide support for regulatory inspections including tracking inspection requests, retrieving and copying requested documents, and contacting subject matter experts as needed.
� Converted all paper TMF files to electronic format to set up a workable eTMF system for future use.


Karyopharm Therapeutics, Newton, MA, USA August 2015 � May 2016
Quality Coordinator
� Assemble, track and maintain company-wide training binders and materials to ensure FDA GMP/GCP Compliance.
� Document, track and route clinical site audit reports for approval and execution in order to solicit Audit Responses in compliance with on file Quality Agreements.
� Track Quality and Master Service Agreements for potential renewal or renegotiation.
� Route and ensure accuracy of incoming study reports for approval to be used for upcoming New Drug Application (NDA) to FDA.
� Maintenance and tracking of all on-site regulatory documentation in preparation for any upcoming FDA GCP/GMP Audits.
� Production of audit certificates for GMP and GCP vendors.
� CAPA tracking of GCP/GMP issues and follow up to resolve issues for FDA compliance.
� Oversight of GMP vendors requesting in-depth records of deviations based on set timelines.
� Collection, reconciliation, and preparation of R&D reports for IND submissions including entry of metadata in eDMS (Veeva).
� Assessment and tracking of company-wide compliance with implanted Standard Operating Procedures (SOP).
� Preparation of internal documents for audit, as well as performing audits on the eTMF (Electronic Trial Master File).


Molecular Insight Pharmaceuticals, Cambridge, MA, USA Jan 2012 � Dec 2012
(Company Acquired by Progenics Pharmaceuticals)
Program Management/Legal Associate
� Responsible for clinical review of incoming trial data including enrollment statistics as well as locations and distances from nuclear pharmacies for subsequent trial phases.
� Maintenance and conducting quality checks of Trial Master File ensuring GCP, ICH, and FDA compliance.
� Assist in execution of contracts as well as redlining of contracts concerning clinical site and financial agreements.
� Support project team with relevant site enrollment and performance information to pinpoint for early termination.
� Assist legal department with drafting, signing, and execution of confidentiality agreements, as well as entry in to electronic database and paper filing.


PAREXEL International, Billerica, MA, USA May 2011 - Oct 2011
Sr. Records Management Associate (Contract)
� Creation, maintenance, and archive of Trial Master Files in accordance with PAREXEL Standard Operating Procedure (SOP), GCP, ICH and FDA regulations.
� Conduct quality control checks of central files in accordance with PAREXEL SOPs and operational best practices relating to document management and record keeping requirements.
� Maintain PAREXEL�s electronic document management system, and ensure quality and content of paper and electronic central files.
� Coordinate close out activities of central files and provide support to Clinical team for termination visits to ensure proper documentation.
� Communicate with investigative sites and vendors to resolve discrepancies and ensure timely completion of clinical studies.
� Support project team for internal and external audits.













RELEVANT WORK EXPERIENCE

Molecular Insight Pharmaceuticals, Cambridge, MA, USA May 2009 � Aug 2009
Legal Intern
� Responsibilities included records management for CDA agreements, client information and documentation control management of various electronic files for upper management.
� Routing and execution of CDAs (Confidentiality Agreements).
� Scan and organize all current and past CDAs as well as contractual and loan obligations for review and reference purposes.

Molecular Insight Pharmaceuticals Dec 2008 � Mar 2009
Project Management Intern
� Research and catalogue data for future clinical trials, including locations of nuclear pharmacies in close proximity to critical hospitals.
� List, rank, and provide pertinent patient enrollment data for all hospitals in the United States.

Molecular Insight Pharmaceuticals May 2008 � Aug 2008
Project Management Intern / Documentation Intern
� Research, combine, and catalogue data for recently finished Phase II clinical trial and highlight successes/failures as well as classify Tier 1 High Priority sites for future clinical trials.
� Detailed analysis of Phase II/III clinical cardiac diagnostic study to create a comprehensive investigator database with key metrics defined for use in planning Phase III study for clinical operations and market research.
� Create graphical representations reflecting Phase II clinical trial�s overall performance comprised of patient enrollment statistics for hospitals involved in the study.

EDUCATION

University of Massachusetts � Amherst, Amherst, MA, August 2010
B.A. Legal Studies
Boston University � Boston, MA, July 2014
Paralegal Certificate

SKILLS/TECHNOLOGIES USED

FDA Regulations, GCP, ICH Guidelines, MoH Requirements for various European countries, eTMF, CLIO, PACER, e-filing, WestLaw, CaseMap, LexisNexus, Microsoft Office Suite, Adobe Suite, Paralegal Certification, Veeva Vault