Case 1: Management of Writing for Global Clinical Report Project
- Need: Bring older clinical study reporting (including CSRs and PhRMA web synopses) in line with current regulatory requirements and SOPs
- Solution: Manage $10 million, international team to assess existing data and documents, assist in development of processes, assist in hiring of CROs and in-house consultants, manage writing of documents to regulatory and internal deadlines, interface with internal departments, country offices and/or their representatives and other stakeholders as needed
- Management of 2 CROs plus in-house consultants
- Maintain compliance with regulatory guidelines
- Develop efficient and effective processes
- Assist in contract development
- Clinical study reports; all components and report types
- PhRMA web synopses
Case 2: Launch of New Department
- Need: Start-up conference company wants to enter pharmaceutical/biotech/healthcare market but lacks experience
- Solution: Assess target industries to identify hot topics using primary and secondary sources and identify market, develop profit targets and assess expenses, build staff with internal transfers and new hires, promote new department, manage and train staff, ensure department meets profit goals with $2.5 million in revenue
- Manage in-house staff of 6
- Assess industry trends
- Create marketing and PR plan and implement for department
- Profit and loss responsibility
- Develop efficient and effective processes
Case 3: Oncology
- Need: Multimedia disease awareness and treatment option program series targeted to oncologists and oncology nurses
- Solution: Managed development of and wrote/edited selected components for 4 years of educational programs unified by message, tone and style for leading oncologists and oncology nurses
- Anemia of Cancer Working Group Web site, 2001-2003 (note: no longer active)
- Anemia of Cancer Tool Kit, including slides and notes
- Core curriculum including slides, CD, USB, and instructional materials
- Kit for building nursing skills including 3 mini-monographs and CDs with narration of monographs and case study
- Lecture series
- Audio and video CD series
- Newsletters
- Meeting reporters
- Monographs
- Additional slide kits
- Anemia assessment tool in English and Spanish
- Faculty identification and recruitment
Case 4: Cardiovascular Disease
- Need: Forum for communication about vascular biology, an area of growing clinical importance
- Solution: Assisted in development of grant proposal, managed development of program and wrote/edited majority of components
- Vascular Biology Working Group Web site, www.vbwg.org, award winning site, creation of majority of content for first year plus
- Core curriculum including slides and notes
- Organization of Steering Committee meetings
- Organization of several lecture series
- CD with slides and notes
- Monographs
- Data alerts
- Curriculum updates
- Identification and recruitment of faculty
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