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Senior Manager, Public Policy, International Government and Regulatory Affairs

4 months ago


Rockville, Maryland, United States United States Pharmacopeia Full time

Description

Who is USP?

The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 talented professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide.

At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare.

USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

Brief Job Overview

The Senior Manager, Public Policy in International Government and Regulatory Affairs (IGRA) is an integral position within a global team of public policy and regulatory affairs experts. The candidate will play an active role in the development of evidence-based policy positions and advocacy strategies to advance USPs mission and impact. Examples of policy areas include, but are not limited to, the integrity of the global medicines supply chain, addressing sub-standard and falsified medicines, and ensuring quality throughout the life cycle of medicines.

Working collaboratively with colleagues across USPs global organization, the policy content generated and managed by the Senior Manager will be utilized in dialogues with policy makers and influencers. It will be delivered in multiple platforms including policy forums, whitepapers, and various communications channels.

Essential skills include the ability to synthesize and clearly communicate including in writing - complex policy issues to a variety of audiences, as well as the ability to collaborate effectively across cultures and geographies.

How will YOU create impact here at USP?

Actively contribute to USPs thought leadership by researching, developing and writing evidence-based and science-led policy positions relevant to USPs mission. Examples of focus areas include ensuring the quality of medicines across the life cycle and integrity of supply chain.

Specific focus is on collecting and synthesizing international perspectives on existing and evolving policy positions related to USPs mission. This involves an understanding of the diversity of healthcare systems across the globe, as well as the interplay between US and ex-US policy.

Play an active role in supporting the execution of key projects within the International Government & Regulatory Affairs Team and broader Global External Affairs Team. This requires strong collaboration skills, agility working in a global environment, ability and willingness for hands-on work, and critical thinking skills to identify highest-impact opportunities.

Support the expansion and strengthening of USPs network of global experts and leaders. This includes collaborating with public policy team members across the globe to expand and develop USPs network of expert volunteers and bring global expertise and insights into USPs work. Embrace and emulate USPs Core Values (Foster Stewardship, Act Courageously, Passion for Quality, Commitment to Others); high ethical standards; and commitment to Diversity, Equity, Inclusion & Belonging.

Who USP is Looking For?

The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:

Bachelors degree required in relevant field (Public Policy, Public Health, Political Science, Law, Pharmacy, Medicine, Life Sciences, etc.).

Eight (8) years of experience in public policy, public health, and/or regulatory affairs, including experience working with international teams.

Prior experience working for a science-based organization related to public health or pharmaceuticals. Examples include NGOs, government, non-profit organization, or industry/private sector organizations. Experience with perspectives across sectors / disciplines in healthcare ecosystems is preferred.

Experience with and knowledge of policy making processes and analysis, including researching writing policy briefs, policy positions and other tools.

Experience developing statements for the record, formal comment letters, and evidence-based policy position statements.

Excellent content analysis, synthesis and writing skills are required.

Excellent communication, presentation, and interpersonal skills, as well as experience communicating across cultures.

Strong thought leadership and the ability to synthesize and report complex information, think broadly, and develop applicable strategies to align with expected outcomes.

High-level and systematic organizational skills, the ability to set priorities, and to cope with change.

Ability to effectively manage projects, including collaborating with key stakeholders and managing timelines and budgets.

Additional Desired Preferences

Advanced degree (such as Masters or Doctorate) in public policy, public health, law, pharmacy, medicine, or another related field strongly preferred.

Experience working in a matrixed organization.

Understanding of medicines quality and healthcare policy topics.

Expertise in conducting literature searches and evidence-based reviews, soliciting expert opinion through various methods, and writing/editing sound scientific reports on a wide variety of topics and issues related to public health and public policy.

Comfortable dealing with complex science, legal, and policy related issues, with a demonstrated ability to simplify and communicate complex science, legal and regulatory policy issues effectively.

Ability to handle multiple priorities in a fast-paced environment.

Demonstrated initiative and successful management of multiple projects.

Strong team building skills in the management of cross-functional teams.

Strong critical thinking and problem-solving skills.

Ability to influence and drive initiatives without direct authority.

Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.

Demonstrable commitment to public health/patient safety/consumer protection, familiarity with global public health issues is an advantage.

Supervisory Responsibilities

None. This is an individual contributor role.

Benefits

USP provides you with the benefits you need to protect yourself and your family today and tomorrow. From company-paid time off, comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial wellbeing is protected.

COVID-19 Vaccination Policy (will apply to the selected candidate(s) hired):

As a condition of employment with the United States Pharmacopeial Convention's (USP) duty to provide and maintain a workplace free of known hazards, all employees and contingent staff hired after July 1st, 2021, must be fully vaccinated unless a reasonable accommodation is approved. Your recruiter will advise accordingly.

Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractors legal duty to furnish information. 41 CFR c)

Job Category Ext. Affairs, Regulatory, & Communications

Job Type Full-Time