Daniel P. Silver
East Falmouth,MA
Summary
Accomplished professional with expertise in regulatory compliance and project management, demonstrated at PTC Therapeutics. Skilled in contract negotiation and fostering collaborative team environments. Proven ability to streamline processes and enhance operational efficiency, achieving up to 15% budget optimization while driving impactful outcomes across education and legal sectors.
Overview
23
23
years of professional experience
Work History
English Teacher
Saint John Paul II High School
Hyannis, Massachusetts
08.2023 - Current
- Incorporated technology into lessons to enrich learning experiences and support student engagement.
- Designed lesson plans tailored to diverse learning styles, fostering student engagement and participation.
- Facilitated classroom discussions to enhance student understanding.
- Implemented assessment tools to evaluate student progress.
- Regularly updated parents on student performance and behavior, strengthening home-school communication.
Attorney, Private Practice
Law Offices of Daniel Silver, Esq.
East Falmouth, MA
02.2014 - 01.2022
- Worked with clients to increase and/or enforce child support and other court orders.
- Leveraged several law school courses on Alternative Dispute Resolution to help couples settle and avoid a lengthy court process.
- Navigated legal complexities of divorce proceedings for family member, providing strategic guidance throughout the process.
- Advised clients on bankruptcy options, preventing Chapter 7 filings for several clients while guiding others through the process.
- Negotiated pre-trial diversions for criminal cases involving DUI and Assault and Battery.
- Managed seven license-to-carry cases for clients, ensuring compliance with local regulations.
- Ensured proper execution of IEPs for families in public school districts, facilitating access to necessary educational resources.
Coordinator, Global Medical Affairs Regulatory Operations
PTC Therapeutics
Lynnfield, MA
06.2019 - 02.2021
- Reviewed complex documents for FDA submissions including but not limited to Clinical Study Reports, Informed Consent, Lay Summaries and Study Protocols, and Chemistry, Manufacturing and Control documentation.
- Edit documents to ensure compliance with federal regulations in both style and substance.
- Negotiated contracts with CRO’s to support clinical trials, sometimes along with Legal Dept., sometimes solo.
- Liaised with the legal department and managed the contracting process using the Contrax software system.
- Created and edited numerous legal contracts.
- Oversaw budget reconciliation of invoices to purchase orders, ensuring adherence to projected budget norms.
- Oversaw the constant assessment of potential issues that impact the overall budget which included but were not limited to site delays (several causes), expensive travel to various sites and employee retention/turnover from any three of the site teams, CRO or PTC itself.
- Collaborated with marketing agencies (PRECISIONscienta and others) to develop awareness materials for rare diseases targeting doctors, patients, and caregivers.
- Created and managed process for Investigator Initiated Studies (IIS), including platform design and functionality with vendor PwC.
- Acted as 'superuser' for VEEVA RIM/Promomats system for approval of documents for internal and external-facing documents (CMLR).
- Submitted and followed through approval any Advisory Board projects through PTC's Encompass system.
English Teacher
Lawrence Public Schools
Lawrence, MA
10.2018 - 12.2018
- Collaborated with at-risk students to enhance academic achievement in English, supporting their transition to post-secondary employment.
- Guided students through standardized test preparation, facilitating access to academic opportunities in Lawrence.
- Developed engaging lesson plans aligned with curriculum standards.
- Facilitated classroom discussions to enhance student critical thinking skills.
- Implemented diverse assessment methods to evaluate student progress.
Internship as Attorney
Law Offices Phil Busey
Oklahoma City, OK
08.2003 - 12.2004
- Prosecuted criminal cases for tribal leaders, focusing on DUIs and assaults on tribal lands.
- Negotiated contracts for casinos on tribal lands, ensuring compliance and protecting tribal interests.
- Acted as quasi-attorney for multiple Native American Tribes in Oklahoma, advising on legal matters.
- Developed economic plans for tribal leaders, outlining strategies to enhance economic growth and sustainability.
Education
J.D. - Law
Oklahoma City University
Oklahoma City, OK12-2004
Skills
Classroom management
- Student assessment
- Curriculum development
- Educational technology
- Data analysis
- Regulatory compliance
- Project management
- Contract negotiation
Timeline
English Teacher
Saint John Paul II High School
08.2023 - Current
Coordinator, Global Medical Affairs Regulatory Operations
PTC Therapeutics
06.2019 - 02.2021
English Teacher
Lawrence Public Schools
10.2018 - 12.2018
Attorney, Private Practice
Law Offices of Daniel Silver, Esq.
02.2014 - 01.2022
Internship as Attorney
Law Offices Phil Busey
08.2003 - 12.2004
J.D. - Law
Oklahoma City University