Job Title: Research Scientist
Overview:
We are seeking a Research Scientist to participate in the development, conduct, and reporting of corporate/global clinical trials. The ideal candidate will have expertise in global clinical trials, including protocol implementation, review, and oversight.
Responsibilities:
1. Develop and maintain Draft Launch Label and Value Proposition
2. Contribute to business unit and global alignment of clinical strategy and clinical plans
3. Understand and keep updated with pre-clinical and clinical data relevant to the molecule
4. Plan, collaborate on, and review scientific content of clinical documents
5. Provide protocol oversight and input into informed consent documents
6. Support the monitoring of patient safety during study and participate in the global product safety reviews
7. Collaborate with clinical research staff in the design, conduct, and reporting of local clinical trials
8. Review and collaborate with CRP on the approval of risk profiles
9. Participate in investigator identification and selection, in conjunction with clinical teams
10. Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct consistent with Good Clinical Practices (GCPs) and local laws and requirements
11. Assist in planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel
12. Serve as a resource to clinical operations/CTMs/clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of study
13. Understand and actively address the scientific information needs of all investigators and personnel
14. Review IT proposals and publications, as requested by CRP or Director-Medical
15. Participate in reporting of clinical trial data in Clinical Trial Registry activities
16. Support the planning of symposia, advisory board meetings, and other meetings with health care professionals
17. Prepare or review scientific information in response to customer questions or media requests
18. Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs
19. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis
20. Support the design of customer research as medical expert
21. Support medical information associates in preparation and review of medical letters and other medical information materials
22. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts)
23. Develop and maintain appropriate collaborations and relationships with relevant professional societies
24. Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons, and global patient outcomes personnel
25. Provide congress support (for example, availability to answer questions at exhibits, provide oral and poster presentations, staff medical booth, meet thought leaders, and participate in customer events)
26. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications
27. Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal
28. Provide medical expertise to regulatory scientists
29. Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports, and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, from a global perspective
30. Participate in advisory committees
31. Participate in risk management planning along with affiliates and Global Patient Safety (GPS)
32. Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates, and other cross-functional management during the development of the local business plan
33. Understand and anticipating the scientific information needs of all Development customers (payers, patients, health care providers)
34. Actively address Development customer questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts
35. Establish effective collaborations with marketing personnel in the various geographic regions to further corporate demand realization
36. Establish and maintain contact with external experts and opinion leaders
37. Maintain a credible scientific expertise to facilitate these contacts
38. Contribute as a scientific and medical expert to activities and deliverables of the PRA organization, in particular giving clinical input and insight to develop payer partnership programs and defend the product value
39. Support business-to-business and business-to-government activities as medical expert
40. Contribute actively on an ongoing basis to the strategic planning for the brand
41. Offer scientific and creative input to the development, review, and approval of promotional materials and tactics as needed
42. Become familiar with market archetypes and potential influence on the medical interventions for the product
43. Take a leadership role in defining the Patient Journey and corresponding Moments of Truth based on his/her medical knowledge
44. Become a patient advocate, as well as a medical expert
45. Participate in PhRMA or other local or national trade associations as appropriate
46. Critically read and evaluate the relevant medical literature
47. Know the status and data from competitive products
48. Keep updated with medical and other scientific developments relevant to the product