Kristin Stephan Email and Phone Number

-Platform lead for the nephrology therapeutic area, responsible for the oversight, planning, and execution of clinical and regulatory documents-Manage writing team working on nephrology clinical development programs

- Author sections of complex clinical and regulatory submissions- Represent Medical Writing in strategic planning activities for NDAs, MAA, and other regional marketing applications for initial and supplemental files- Align, coordinate, and build consistent information and messages across clinical programs- Establish program-level standards (e.g., style conventions, data presentation standards)- Provide leadership related to the activities of the Medical Writing department- Proactively anticipate risks, solve complex problems, and seek out and implement process improvements- Promote and foster collaborations with colleagues in other functions- Train, mentor, and supervise Medical Writing staff- Oversee contractor outsourcing planning, resourcing, contracts, and budget

- Prepare clinical study protocols, clinical study reports, investigator brochures, summary documents, regulatory briefing documents- Oversee work of contract medical writers- Represent Medical Writing Department at cross-functional clinical development team meetings as the lead writer for a CF therapy in Phase 3 trials

- Prepare slide decks and Q&A materials for Executive Committee use, including Board of Director meetings and Investor Relations presentations- Draft communications for internal and external use by the Chief Medical Officer- Plan and manage agendas for the Global Medicines Development and Affairs (GMDA) Leadership Team Meetings- Serve as GMDA representative to Business Development meetings

- Prepared clinical study reports, clinical study protocols, investigator brochures, periodic safety reports, summary documents, regulatory briefing documents - Oversaw work of contract medical writers- Represented the Medical Writing Department at cross-functional clinical development team meetings as the lead writer for HCV and Rheumatoid Arthritis compounds- Lead author for Summary of Clinical Safety for simultaneous submission of NDA/MAA in the CF therapeutic area

- Engaged in publication planning and drove implementation within the guidance ofGood Publication Practices 2- Drafted and edited abstracts, conference presentations, and manuscripts- Built and maintained relationships with internal and external stakeholders- Managed activities, timelines, and budgets for vendor-assisted deliverables- Represented HCV publications team at payer, public health, and community liaison meetings- Mentored junior medical writer- Contribute to the drafting and revision of Standard Operating Procedure documents

- Collaborated with cross-functional teams on the development of HCV therapeutic areapublication plans- Drafted and managed the development of scientific publications within the guidance of GoodPublication Practices 2- Established and maintained relationships with internal stakeholders and external clinical trialinvestigators- Provided editorial review of individual publications for accuracy and alignment with MedicalAffairs' educational strategy- Represented the HCV publications team at payer and public health team meetings- Mentored and assisted in the training of new medical writer and publication team coordinator

-Served as Chair of the Chapter Executive Council and as ex-officio member of all committees-Served as member of the National AMWA Endowment Fund Subcommittee-Prepared annual chapter report for National AMWA office- Wrote and disseminated chapter e-News blasts-Liaised closely with the incoming Program Director and outgoing President as needed to facilitate smooth officer transitions

-Responsible for planning and arranging 4 regional meetings of high caliber and wide appeal -Served as Chair Person of the Nominating Committee, which identifies potential officers for the following year-Served as delegate to the National AMWA Board of Directors Meeting

-Designed and executed scientific research in transplantation-Prepared manuscripts-Served as peer reviewer for The Journal of Clinical Immunology

- Selected equipment and consumable reagents to set up the laboratory- Directed and performed basic science research (innate immunity, mouse genetics)- Wrote and submitted grant applications and manuscripts- Presented research findings at international meetings- Aided in the training of junior lab members- Served as a student representative to the faculty senate- Developed and troubleshot novel research protocols and techniques