Assigned to case management which includes compliance evaluations, disposition and follow-up of foreign pharmaceutical manufacturing facilities; developed and implement for- cause assignments, warning letters, import alerts, injunctions and other regulatory actions. Lead case officer in a number of high profile cases which resulted in significant regulatory actions. Have broad experience with the various FDA/ORA systems. Conduct briefings to FDA senior management and presentations (internal to FDA and to industry representatives), and conduct meetings concerning proposed regulatory actions and strategies addressing case assignments and regulatory compliance. Perform evaluation of compounding pharmacies and develop case activities. Respond to GMP industry inquiries, addressing post market quality reports (foreign field alert reports, Medwatch reports), Subject Matter Expert (SME) in the areas of cross contamination and root cause and special assignments. As a Senior Policy Advisor I am also responsible for the creation and implementation of the OC IO Quality Systems Management and other policy related activities as required. As a Senior Policy Advisor in the office of the OMQ Director, in addition to my responsibilities in a collaboration project with CDER Office of Compliance IO, I am also responsible in drafting position papers, presentations for internal/external audiences, recommending enforcement strategies in high profile cases and addressing complex regulatory compliance developments.
- Senior Policy Advisor at Food and Drug Administration
- at Food and Drug Administration
- Senior Policy Advisor at Food and Drug Administration (FDA)
- CSO/Microbiologist at Food and Drug Administration
4 years, 9 months at this Job
- Master's - Microbiology
- M.S. - Microbiology
- B.S. - Biology
Identify and analyze key policy developments, trends, and solutions on a state and federal level. Craft policy/advocacy strategies. Cultivate and maintain relationships with policymakers. Track and interpret regulations and legislation. Manage member communications and executive level member company councils including financial institutions, insurance companies, and multifamily lenders. Plan and develop content agendas and identify speakers for MBA conferences. Deliver weekly and daily member C-Suite policy communications, briefings, and newsletters. Manage policy campaigns and conduct research.
- Policy Advisor at MORTGAGE BANKERS ASSOCIATION
- Government Affairs Specialist at
- Political Affairs PAC Intern at INDEPENDENT INSURANCE AGENTS & BROKERS OF AMERICA/INSURPAC
- MAJORITY LEADER ERIC CANTOR at U.S. CONGRESS
2 years, 2 months at this Job
- B.A. - Political Science
Provided policy and legal advice to the Democratic Candidate in New York's 19 th District, Antonio Delgado, in a competitive race for the House of Representatives. Researched policy issues, identified potential political concerns, and drafted memos and other written works for use in campaign materials and in preparation for speaking engagements. Assisted the candidate on messaging and communications, specifically around the issues of health care, immigration, and rural and economic development. Took a lead role in debate preparation with candidate.
- Policy Advisor at DELGADO FOR CONGRESS
- Litigation Associate at AKIN GUMP STRAUSS HAUER & FELD LLP
- Judicial Clerk at THE HONORABLE VANESSA GILMORE, UNITED STATES DISTRICT COURT
- Legal Intern at COUNCIL OF STATE GOVERNMENTS JUSTICE CENTER, New York
5 months at this Job
- J.D. - Casebook Research & Writing Editor
- Bachelor of Arts in English - English
• Manage 52 high profile initiatives related to Thrive NYC, NYC's $850 million-dollar investment in mental health.
• Advise Executive Deputy Commissioner, Deputy Mayors, and First Lady of New York City, on Mental Hygiene policy and programming
• Create scientific papers and briefs for high-profile programs.
• Work with City Hall and other agencies on city issues to create policy and implementation plans such as suicides in TLC and NYCHA or the intersection of mental health & criminal justice.
• Responsible for planning, strategizing, and implementing Cities Thrive Coalition, representing a membership of over 200 cities.
• Work with internal teams to strategize new program development, problem solve implementation issues, and stick to timeline.
- Policy Advisor at NYC Department of Health and Mental Hygiene
- Policy Manager at NYC Department of Education
- Vetting Coordinator at
- Senior Field Organizing Fellow at New Yorkers for Bill de Blasio
2 years, 9 months at this Job
- B.A. in Political Science - Politics
Strategic Policy Advisor in the DCHS Director's Office, serving the greater Seattle/King County metropolitan region. Member of the DCHS management team, analyst, researcher, strategist and innovator of cross-sector, inter-departmental and inter-jurisdictional projects, initiatives and programs. Worked with partners inside and outside of County government, and with stakeholders and communities, to design and align policies, systems and programs that build community capacity and help communities to thrive and reach their full potential. I approach the work as a life-long learner and change agent, embracing research and new and cutting-edge ideas for advancing shared prosperity. Served on the leadership team of the DCHS Equity and Social Justice Initiative work plan. Accomplishments include: regional leadership in developing a new public-private $21 million regional equitable transit-oriented development initiative (REDI) loan fund; co-design with community partners and leadership in developing the King County Best Starts for Kids Levy and the Communities of Opportunity initiative; leadership in securing a 3-year Living Cities grant to participate as a regional cohort in their national Integration Initiative; leadership on behalf of DCHS on the inter-departmental team for the King County Comprehensive Plan policy document, and success in developing a new chapter in the 2016 plan addressing Housing, Health and Human Services and applicable inter-departmental policy actions.
- Strategic Policy Advisor at King County Department of Community & Human Services (DCHS) Director's Office
- Program Director at King County Housing and Community Development
- Section Lead, Housing Planning and Development at King County Housing and Community Development
- Managing Attorney, Housing Justice Project at King County Bar Association
4 years, 3 months at this Job
- Juris Doctor
- Bachelor of Arts
Serve as a primary advisor to the National Security Advisor on policy issues, including political violence, counterterrorism, and the U.S.-Afghan relations, and serve as a liaison to the U.S./European stakeholders, including embassies and agencies, for expert briefings. - Conduct in-depth primary and secondary research and analysis and develop papers and policy briefs on Afghanistan peace process, including on post-peace scenarios, for the National Security Council/the President. - Prepare progress reports, participate in strategic planning, maintain partnerships with relevant stakeholders, including political groups and civil society, to support and promote the peace process and reconciliation.
- Senior Policy Advisor, Kabul at OFFICE OF THE NATIONAL SECURITY COUNCIL
- Fellow at South Asia Center
- Senior Intelligence Manager at Modern War Institute
- Non-Resident Fellow at Modern War Institute
4 months at this Job
- M.A. - National Security Studies
- B.A., Economics (Hons - Economics
Bureau of Justice Assistance
810 7th St., NW
Washington, DC 20531
State Policy Advisor/Grants Management Specialist
May, 2010- 1/4/2019 (retired)
40 hours per week
Supervisor: Erich Dietrich
Telephone: (202) 616-1733 As a State Policy Advisor/Grant Manager, I worked in partnership with the State Administering Agency (SAA) and other Bureau of Justice Assistance (BJA) grantees in implementing strategies that educate, reduce crime, improve public safety, train attorney's to serve the indigent population, problem solving courts, and substance abuse. I serve as the primary point of contact for grantees and constituents in various States, Missouri, Michigan, DC, New York, Virginia, Washington, Oregon, Alabama, North Carolina, Pennsylvania, and Florida. I expertly manage the daily grant activities of a portfolio of 214 grants and cooperative agreements. I ensured Federal funded project implementations were compliant with Federal regulation and guidelines. The scope of my duties were to:
• Reviewed applications for possible award,
• Evaluated applicants' budgets to ensure that budget items are allowable, allocable, and awardable
• Assessed applicant's ability to meet program objectives; recommend appropriate actions based on requirements
• Interpreted complex program requirements assuring compliance with special legislative mandates; identify problem areas.
• Provided grantees with feedback after reviewing, assessing and evaluating their application for funds
• Determined if grantees' requests for financial/programmatic modifications are compliant with the Office of Management and Budget Uniform Guidance, the funding agency guidance the solicitation
• Conducted annual site visits to grantee's organizations to determine grantee's compliance with the conditions of the award. More specifically, the purpose of the site visit is to assess and ensure the grantees compliance with the regulations, terms, and conditions for each Office Of Justice Program's grants
• Reviewed the programmatic success of each grant
• Determined the grantee's financial integrity and
• Provided technical assistance
- State Policy Advisor/Grants Management Specialist at US Department of Justice
- State Project Officer at
- Public Health Advisor at Administration (SAMHS), Center for Substance Abuse More
- at Substance Abuse and Mental Health Services Administration
8 years, 8 months at this Job
- Graduate Certificate - Business Administration
- Master of Science in Administration - Administration
- Bachelor of Science degree - Criminal Justice
• Made policy and program recommendations and set program mission, goals, and objectives. · Developed professional development instructional materials to present at workshops statewide based on state resources. · Presented at various professional business and professional development workshops, as well as informational presentation. · Managed state programs, identifying new engagement channels outreach strategies, and process improvement measures through metric and data analysis. · Created programs to build a more robust business network to meet state procurement goals.
• Designed strategic marketing plans for outreach initiatives, creating marketing content and new distribution channels.
• Documented project activities to ensure project deliverables are met and expenditures accounted for.
• Represents the State and veteran interests on multiple legislative Veteran Advisory Boards and community groups statewide to strengthen partnerships and outreach measures.
• Serves as lead for development of the vision and execution of operations for the State's largest veteran event; coordinating with dozens of volunteer veteran organizations, Governor's Office, Legislators, National Guard, and State Fair personnel.
- Senior Programs Policy Advisor at Illinois Department of Veterans Affairs
- Plans, Operations & Training Officer at Illinois Department of Military Affairs
- eLearning Consultant at Consulting 101
2 years, 2 months at this Job
• Develop and draft legislation authored by the Chairman
• Serve as primary point-person in negotiations with stakeholders on legislation and various votes taken by the Chairman
• Manage multiple, complex calendars for a high-ranking member of House Leadership and top-level staff
• Foster communication and consensus building between members of the State Legislature, interest groups, and lobbyists to pass key legislation
• Act as constituent advocacy intermediary between constituents and county agencies
- Policy Advisor at Office of State Representative Charlie Geren
- at HBW Resources - Legislative Fellowship
- Deputy Assessor at Sabine Parish Assessors Office
- Legislative Assistant at Office of State Representative Oscar Longoria
6 months at this Job
- Bachelor of Arts - Government
Promote the legislative agenda for an elected State Senator. Analyze and evaluate pending legislation to prepare Senator for policy committee hearings and floor votes. Draft presentation remarks, draft language for press releases. Coordinate with stakeholder organizations. Improve proposed legislative language. Senator's representative in meetings with constituents.
- Sr. Policy Advisor at California State Senate
- Self-Employed at Self-Employed
- Chief Consultant at California State Assembly
- Senior Manager-National State Public Policy and Reimbursement at Amylin Pharmaceuticals, Inc
1 year, 2 months at this Job
- Bachelor of Arts in History/Political Science - History/Political Science