PhRMA Careers, Director – Scientific & Regulatory Affairs
Director – Scientific & Regulatory Affairs
Pharmaceutical Research and Manufacturers of America’s (PhRMA’s) Scientific and Regulatory Affairs (SRA) team has an immediate need for a Director with strong project management, communication and relationship building skills to support strategic initiatives and activities related to scientific and regulatory advocacy priorities.
The Director will serve as the PhRMA Coordinator regarding engagement with the International Conference on Harmonization (see www.ich.org). As the PhRMA ICH Coordinator, the Director will interact and liaise with regulatory agency officials and industry experts to ensure the successful coordination and support for ICH work groups and initiatives. The Director will also provide project management support for the operational and tactical execution of SRA Leadership Committee (subject matter experts from PhRMA member companies) priorities and objectives related to product quality and supply chain integrity.
The Director is responsible for:
- Serving as the PhRMA ICH Coordinator. Responsibilities include: convening and coordinating working groups of PhRMA member company experts who support ICH guideline development and implementation; serving as a liaison with regulators and industry stakeholders; serving as a main point of contact for the governing body of the ICH; ensuring successful communication of PhRMA engagement in ICH activities with SRA Leadership Committees; responsible for the overall project management of PhRMA work groups that support ICH regulatory harmonization activities; and providing support to the PhRMA ICH Steering Committee member.
- Providing direct project management support for strategic initiatives related to global pharmaceutical product quality, manufacturing, and supply chain integrity. Responsibilities include: convening and coordinating working groups of PhRMA member company experts; serving as the liaison with the SRA Leadership Committee; facilitating strategic planning initiatives; coordination and oversight of additional activities; building project work-plans including deliverables/milestones and identification of short and long-term goals; ensuring clear coordination and communication and tracking the progress of initiatives; creating Committee meeting agendas, assisting in preparation of meeting materials, and drafting/distributing minutes when appropriate.
- Supporting other departmental and cross-departmental priorities such as activities that advance PhRMA’s international scientific and regulatory affairs global regulatory harmonization activities and regulatory reform priorities in the emerging markets.
Key Success Factors
PhRMA is seeking a highly-organized, effective, and strategy-driven scientist or regulatory affairs professional knowledgeable about the pharmaceutical industry who ideally has experience interacting with U.S. FDA, the European Medicines Agency, and/or the Japan MHLW/PMDA.
Critical to the success of this role is the ability to understand the evolving and dynamic nature of the regulatory environment while managing multiple projects, competing priorities and deadlines.
- Bachelor’s degree in life sciences or related discipline;
- 5-8 years of directly related experience including extensive project management;
- Working knowledge of the regulation of medicines in the United States;
- Strong relationship building skills including the ability to effectively engage with internal and external stakeholders;
- Exceptional written and verbal communication skills;
- Ability to travel internationally (at least three times per year).
- Advanced degree (PharmD, MPH, MSc) in biomedical/ biopharmaceutical sciences, health policy/ public health or similar discipline;
- Working knowledge of international regulatory systems – notably those in Europe, Japan, and emerging international pharmaceutical markets (BRIC-TM);
- Pharmaceutical industry experience.
Who we are
PhRMA is a non-profit trade association representing innovative biopharmaceutical research and discovery companies. PhRMA is devoted to advancing public policies in the U.S. and around the world that support innovative medical research, yield progress for patients today and provide hope for the treatments and cures of tomorrow.
Our members are committed to finding tomorrow’s cures and treatments for some of the most serious diseases such as Cancer, Alzheimer ’s disease, Cystic Fibrosis and Parkinson’s.
New medicines are an integral part of the healthcare system, providing doctors and their patients with safe and effective treatment options, extending and improving quality of life.
What we offer
In addition to a highly competitive salary, generous 401(k) employer contribution, and platform of benefits (health, dental, vision, life and AD&D, short and long term disability, long term care, and Metro benefit), PhRMA is committed to the development and overall wellbeing of its staff. We offer tuition reimbursement, industry on-site and off-site trainings, and management development programs. We also engage in organization-wide community service activities and charitable athletic events.
Certified as a CEO Cancer Gold Standard employer by the CEO Roundtable and also considered one of Washington’s Healthiest Employers (as awarded by the Washington Business Journal), PhRMA provides a fitness subsidy, on-site fitness facility and fitness classes, an annual health fair and extensive employee wellness seminars, events and challenges.
We are committed to supporting our staff and strive to create programs that help our team manage the challenges of balancing a fast paced career with personal goals.
Equal Opportunity Employer
PhRMA provides equal employment opportunities to all applicants without regard to race, color, religion, national origin, sex, age, marital status, personal appearance, sexual orientation, gender identity or expression, family responsibilities, genetic information, disability, matriculation, political affiliation or veteran status in accordance with applicable federal, state and local laws governing non-discrimination in employment.
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