Responsible for the development and analysis of fair market value pricing for clinical trial agreements including benchmarking fees and drafting and finalizing financial exhibits to clinical trial agreements. Provide support to the clinical team in the budgeting, pricing, planning, execution and control of grants and contracts.
•Analyze pricing requests/needs from operating companies and translating into appropriate budgets/contract exhibits for company sponsored and investigator initiated clinical trial agreements and other ancillary contract documents as they relate to various clinical projects.
•Analyze investigator grants for fair market value aligned with regional knowledge and the J&J pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information.
•Participate in and/or lead the budget escalation review process
•Translate clinical trial protocol requirements into fair market value pricing/budget milestones per company guidelines and policy.
•Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
•Determine potential needs for budget revisions and related contract amendments.
•Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
•Provide virtual training to global clinical trial agreement negotiators.
•Assume responsibility for all aspects of pricing documentation and metrics tracking.
•Work proactively to improve processes and establish refinements that reduce cycle time, create savings and improve efficiency in the initiation of clinical trial sites.
•Mentor and train new pricing assistants, pricing analysts, and contract analysts as needed.
•This is not an exhaustive, comprehensive listing of job functions. Other duties may be performed as assigned.:
DECISION-MAKING AND PROBLEM-SOLVING:
• Adhere to SOPs, ethics and departmental compliance as determined by department management as well as operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with C&G, department and operating companies
• Comply with requests from QA and auditors
CONNECT Develop deep insights into the needs of our patients, customers, markets and communities.
•Cultivate external relationships and partnerships
•Be insight-driven to uncover unmet needs
•Forge internal collaboration across all levels of the enterprise
SHAPE Drive innovation; anticipate and shape industry and market changes to advance health care globally.
•Translate insights into viable products and solutions that create value
•Take and manage risks
•Challenge the status-quo; lead and adapt to change
LEAD Create an environment where leadership and talent development is top priority.
•Take ownership for talent acquisition, performance and development of self and others
•Maximize the power of diversity and inclusion
•Engage in transparent and constructive conversations
DELIVER Drive results by inspiring and mobilizing people and teams.
•Empower people to act with speed, agility, and accountability
•Demonstrate a global and enterprise-wide mindset
•Balance short and long-term strategic choices
LIVE OUR CREDO Demonstrate and inspire the behaviors that reinforce Our Credo.
•Serve as a role model for making Credo-based decisions
•Create a trusting, collaborative, and ethical work environment
•Maintain the highest standards of quality, compliance and accountability
•Champion programs and initiatives that support our environment and communities
REPORTING RELATIONSHIPS: Describe where this position fits in relation to the rest of the department it resides. Attach org chart if available.
This role reports to the Pricing Senior Manager.
EDUCATION & EXPERIENCE REQUIREMENTS:
•Bachelor’s degree, or equivalent, in appropriate scientific or business disciplines
•3- 5 years experience and/or equivalent competencies in pharmaceutical industry/clinical research
•Must have a working knowledge of the clinical development process with 2 years of pricing/budgeting or negotiation and contract experience
•Experience working with IMS GrantPlan system or Medidata Grants Manager system is preferred
•Excellent communication skills (both oral and written)
•Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.
•Ability to work effectively in cross function teams in various levels of the organization
•Strong and proven negotiation and problem resolution skills
•Working knowledge of PCs (MS Office suite at a minimum) and database management
•Must demonstrate ability to work in a fast paced environment and to work independently
•Fluency in English is required
•Previous experience working in virtual teams preferred
Janssen Pharmaceutical K.K. (7195)ジョブ
Clinical Trial AdministrationRequisition ID