Contract Biological Science Writer Jobs in Indiana

Kelly Science and Clinical FSP is currently seeking a Clinical Contract & Pricing Coordinator for a one year contract position with a high chance of extension after that. Local candidates preferred in Warsaw, Indiana. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K (no match) and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

The Clinical Contract / Pricing Coordinator will support the management of clinical research-related contracts, pricing, and payments for orthopedic programs, supporting Business Strategy and Scientific Affairs leads. This role will collaborate with clinical/scientific affairs, project management, finance, compliance, procurement, and legal to draft, negotiate (within delegated authority), complete fair market value assessments, and execute clinical agreements. This role helps ensure contracts align with company policies, timelines, budgets, and compliance requirements. Use contract management/document repositories to track and report status.

• SECTION 2: DUTIES & RESPONSIBILITIES*Prepare, negotiate (with legal guidance), and finalize clinical agreements and ancillary agreements for company sponsored, investigator-initiated/collaborative studies, and real-world evidence studies.
• Work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Partner with Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and drive resolution. Escalate as appropriate.
• Analyze study budgets in relation to fair market value pricing and ensure alignment with regional standards and the Company pricing guidelines. Participate in and/or lead approval escalations as appropriate.
• Assist with tracking all aspects of contract workflow and metrics. Determine potential needs for contract amendments.
• Recommend processes improvements to reduce cycle time, create savings and improve efficiency in contract initiation and execution.
• Support the adjudication of clinical research payments per the terms of an agreement, and in compliance with policies and procedures.
• Adhere to SOPs, ethics and departmental compliance as determined by corporate, HCC and QA guidelines.
• Ensures the maintenance of accurate, project-specific financial working files.
• Provide internal communication of important contract status, changes in contract requirements/regulations and events.
• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
• Maintain inspection-ready documentation and archival records in contract management systems.

SECTION 3: EXPERIENCE AND EDUCATION*

• EducationMinimum of a Bachelor’s/University Degree or equivalent required; preferably in Life Science, Physical Science, Nursing, Biological Science, Finance, Business and/or Law.

• ExperienceA minimum of 2 years of relevant experience (or equivalent) required.
• Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) required
• Experience in contracts management required and payment processing, HCC a plus.
• Previous clinical research or related technical experience and legal experience a plus

• SECTION 4: REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*Requires understanding of Good Clinical Practices
• Strong and proven negotiation and problem resolution skills.
• Understanding and application of regulations and standards applied in clinical areas/regions is required
• Good presentation skills and effectively influencing of others
• Written and oral communication skills