Stephanie Christopher Email & Phone Number

New York, New York, Us

I support the design and execution of patient engagement strategies, research projects, educational projects and development programs that elevate the voice of the patient in product development and positively impact the lives of rare disease patient community.

Danbury, Ct, Us

I oversee NORD’s patient-centered registry platform called IAMRARE. The IAMRARE platform was launched in 2014 with funding from the FDA to fulfill a specific need: to advance natural history studies that are pivotal to the development of new therapeutics for the rare disease community. IAMRARE was developed to empower the rare disease community to become active contributors to research, share their patient journeys and follow the natural history of a disease through the patient experience. In this role, I support the development of new natural history studies that fill knowledge gaps and deliver value to the rare disease patient community. I help provide a strategic vision for the ongoing growth of the program and lead and mentor research staff who are leading multi-stakeholder research initiatives with patient groups, other non-profits and federal partners.

Us

I play an integral role working within Health Insights, a system-wide department with PSJH Research that facilitates research-as-a- service partnerships between external and internal clinical research collaborators. I work with clients (pharmaceutical companies) to develop their scope of work, identify investigators in the systems, define relationships, and serve as a project manager during the execution of the study. ✔ Strategically and effectively utilize system-wide assets to provide translational research, real-world evidence, and clinical trial analytics services✔ Foster and strengthen relationships to facilitate collaborations between pharmaceutical and medical device companies and PSJH clinical researchers and research sites✔ Proactively contribute to and support project protocol development, manage project timelines, and facilitate communication and education of site staff for collaborative research projects. ✔ Contribute to the development of department project management best practices.✔ Tasked with putting structure into the process through the development of protocols on how to intake new clients, assess their needs, and identify partners for the system, resulting in increased efficiency in SOW management.✔ Facilitated effective communication with the 7 different unique healthcare systems, including establishing a finance working group to raise their awareness of health Insights and gain their view on how to best interact. ✔ Developed educational material to broaden awareness and encourage physician engagement in research.

Arlington, Va, Us

I advanced to the position of Program Director for MDIC project initiatives that included Patient-Centered Benefit-Risk Assessment, Clinical Trial Innovation and Reform, and Case for Quality in collaboration with FDA, patient groups, and medical device companies. I delivered strategic oversight of projects, steering efforts, and leveraging industry member, alliance partner, and other stakeholder perspectives and resources in advancing strategic project priorities.✔ Steered and coordinated multi-stakeholder meetings and workshops, committee and working group communications.✔ Identified and contracted for additional project resources and pursued federal and private grants and contracts to support project goals and initiatives. ✔ Led the Patient-Centered Benefit-Risk Assessment initiative, in response to the FDA’s interest that medical device companies should include patient preference information as part of their regulatory submission. The committee published a first-of-its-kind compendium of resources and a framework report on the inclusion of patient preference information in medical device regulatory submissions (2015) – Committee won an FDA Collaboration award (2016). Also headed up development of a suite of resources for the incorporation of patient perspectives into the design of clinical trials ✔ Directed the Case for Quality initiative, an FDA-Industry collaborative initiative to improve the quality of medical device manufacturing and included development of the Case for Quality Voluntary Improvement Program (CFQ VIP), which incentivizes medical devices to participate in a voluntary assessment to advance quality maturity practices at manufacturing sites✔ Collaborated on development, writing, and submission of two Broad Agency Agreement contracts with the U.S. Food and Drug Administration for $500,000 and $880,000, along with providing editorial support on PCORI methodology and FDA U01 grants.

Arlington, Va, Us

Wi, Us

In this position, I worked on research to improve the quality of communication between physicians and patients, facilitating collaboration across a multi-disciplinary team in performance of research projects to assess the processes and outcomes of clinician-patient communication and decision-making.✔ Utilized and helped develop validated communication measures, including measures of physician use of jargon and emotional assessment to assess communication quality.✔ Worked within teams collaborating on the writing and editing of journal articles and scientific manuscripts.✔ Steered the planning, coordination, and management of data collection and analysis for several projects, assuring quality of project data and compliance with Institutional Review Board guidelines and study protocols.✔ Wrote portions of Federal and private foundation grant applications.

Wi, Us

Silver Spring, Md, Us

I utilized expertise in the development and updating of communications materials, including SOPs for material creation, together with updating the training manual, and SOPs for risk communication. The project was funded by an Intergovernmental Personnel Agreement (IPA), which encourages collaboration between Federal agencies, academic institutions, and stakeholders to work on special projects at the FDA. ✔ Worked collaboratively on the development of a new SOP to solicit scientific feedback on public health risk communication messages prior to release to public stakeholders.✔ Partnered with the CDRH Staff College to effectively organize, prepare, pilot test, and implement an online training module to train CDRH staff in risk communication and technology transfer procedures.✔ Steered integration of the new risk communication and technology transfer SOP with existing health communication and risk communication SOPs in the Center.✔ Leveraged expertise and leadership in managing, planning, coordinating, and authoring the Standard Operating Procedures (SOP) manual “External Expertise and Partnerships: Leveraging Resources Manual,” the manual for the Office of the Center Director, CDRH, External Expertise and Partnerships (EEP), second edition.

Milwaukee, Wi, Us

Adjunct Instructor in the College of Professional Studies teaching the course Communication Studies 1000: Introduction to Communication.The course is a survey of communication principles and processes as they relate to interpersonal communication, small group communication, culture and communication, persuasion, communication in organizations, and mediated communication.

Milwaukee, Wi, Us

Taught Communication Studies 012: Public Speaking

Milwaukee, Wi, Us

Lead discussion groups for the course Communication 011: Contemporary Presentation, a hybrid writing and public speaking course.

Tacoma, Wa, Us

Editor-in-Chief of the Mast, Pacific Lutheran University's 16-page student newspaper.Managed a staff of editors and reporters of varying experience, managed budget matters, published the op-ed pages using Quark XPress.Also chair of the student-run University Media Board, which oversees the budget for all PLU student media

Collaborated with the staff on creation of strategic communication plans. Maintained the media clip book and media contact database. Wrote and followed-up on press releases.

Researched and wrote news and feature articles. Also provided copyediting support as needed.

Ma, Communication

Ba, Communication