Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
Working without appreciable direction, provides technical assistance in negotiating, reviewing, and processing clinical study and research contracts and subcontracts in support of clinical research activities. This position will negotiate with research sites, ensure contracts are written in accordance to associated Business Unit and regulatory protocols, obtains necessary approvals from senior management for research sites set-up. Work requires the application of business principles/methods, evaluation, ingenuity, and creative/analytical techniques typically acquired in a recognized four-year academic course of study. Within a specialized range of expertise, applies clinical principles to the solution of a variety of problems; customarily and regularly exercises judgment in planning, organizing and performing own work; completes special assignments and projects as required. Assures that quality of services meets internal and external customer requirements. Remains current on developments in field(s) of expertise.
WHAT YOU’LL DO
- Performs a variety of activities involved in the drafting of contracts for clinical research studies.
- Monitors/reviews proposed contracts for compliance with applicable company policy as well as applicable regulations.
- Writes technical contract language covering such issues as indemnification, subject injury language, intellectual property rights, confidentiality, fiscal/procedural constraints, and other similar matters.
- Maintains up-to-date Legal Department reference file.
- Analyzes and resolves technical problems of contract interpretation and resolves conflicts as necessary.
- Participates in policy discussions and recommends policy or procedural changes as appropriate; revises and updates procedures as necessary.
- Work in conjunction with manager to ensure contractual requirements and timelines are met; ensure adherence to those timelines; communicate milestones and commitments.
- Meet study site activation timelines utilizing effective negotiations skills which results in signed executable agreements Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Support and collaborate with the internal and external stakeholders to achieve departmental goals and the implementation of mitigation strategies to ensure timelines are met.
- Ensure all clinical site contract comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
- Identifies issues/problems and provides customary recommendations for solutions. May focus on either contracts or grants or both areas based on Business Unite needs.
- Works on diverse business problems that require financial analysis with oversight from more senior individuals in department. Assists clinical teams in resolving financial issues as they relate to site contracts.
- Coordinates the preparation, execution, and tracking of domestic clinical site agreements, including study-specific budget templates, contracts and other documents with specific guidance from senior individuals.
- Works closely with internal clinical teams to ensure rapid start-up of study sites. Responsible for tracking the progress of study-start-up activities as it relates to contracts and budgets.
- Responsible for the preparation and ongoing review of study documents throughout the lifecycle of the clinical trial.
- Performs routine work under moderate supervision without detailed instructions and complex tasks under general supervision.
- Collaborate with management to generate and track metric reports
- Demonstrates moderate proficiency in the understand complex budgeting & forecasting tools.
- Interacts well with clinical teams, legal, and payments team.
- Advise manager regarding potential issues. Identifies course of action and works in conjunction with management to implement.
- Create, prepare, review and edit contracts, Master Agreements, statement of work , amendments, modifications and change contract changes of a high complexity level and contract risk type.
- Analyze documents to determine corporate risk; prepare and provide alternative approaches to mitigate the risk.
- Solve unique and complex problems with broad impact on the business; requires conceptual and innovative thinking to develop solutions.
- Maintain communication of negotiation status using Company IT systems.
- Obtain necessary approvals for contractual documents by senior management.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
- Bachelor’s Degree in Business Administration, a related field, or equivalent.
- 2-5 years of related work experience in Contracting, Contracting Negotiations/Skill and in redlining documents
- Typically a minimum of six plus years of analytical experience or equivalent.
- Familiarity with grant and contract requirements, policies, and procedures including, but not limited to Clinical and AdvaMed Code of Ethics on Interactions with Health Care Professionals.
- Knowledge and understanding of GCP, ICH, GLP and other federal, state, industry rules and regulations governing technical aspects of clinical grants and contracts
- Ensure all required data from studies and sites to comply with regulatory and government requirements (Sunshine Act, FWA, Human Subject Protection training, Clinical Insurance).
- Requires a demonstrated knowledge of the practices/procedures of the function, company polices, and programs.
- Requires demonstrated written and verbal communication, interpersonal, presentation, technical, analytical, statistical, organizational, and follow-up skills, the ability to meet deadlines as well as the ability to converse effectively with all levels of employees.
- Consistently demonstrates the ability to understand and take effective approaches to varying levels of communication that would be most efficient and productive.
- Must be able to demonstrate and use discretion in exercising work assignments and handle sensitive/confidential information in an effective manner.
- Must have the demonstrated ability to understand and comply with applicable government regulations and Company operating procedures, processes, policies, and tasks.
- Must have demonstrated personal computer skills including a working familiarity with relevant word processing, database, and spreadsheet applications (i.e., Microsoft Word, Excel and Access). Some evaluation, originality, and/or ingenuity required.
Preferred
- Sponsor Pharma or Biotech experience preferred
- Direct knowledge of Sponsor Clinical Contracting preferred
- Should have a firm understanding of the clinical protocols, including study design, procedures to be performed at each visit, duration of trial, etc.
- Paralegal certification preferred.
- Previous related experience administering and/or coordinating grant and or contract requests in medical device, biologics, or pharmaceutical company.
- Experience preparing and giving presentations.
- Registered nurse, legal, clinical research associate experience desired.
- An advanced degree (i.e., masters and/or doctorate level) as well as professional certifications (i.e., Certified Professional Contracts Manager (CPCM), Certified Clinical Research Professional (CCRP), or related certifications) also a plus.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.