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FSP Sr. Contract Specialist
Pharmaceutical Product Development (PPD)
Remote, North Carolina, United States of America
Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Location/Division Specific Information
(No more than 2-3 sentences)
Discover Impactful Work:
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
A day in the Life:- Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
- Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established critical issue routes.
- Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.
- Ensures compliance of budgetary guidance, templates and process.
- Identifies and assesses legal, financial and operational risks and advances to appropriate level of the organization per established processes.
- Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation
Keys to Success:Education- Bachelors degree or equivalent required.
Experience- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years)
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities- Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
- Demonstrated ability to apply basic principles of investigator grant negotiation
- General understanding of business and financial principles that related to service agreements
- Effective communication skills (verbal & written) in English and local language
- Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
- Demonstrated ability in attention to detail
- Excellent analytical and decision based thinking skills
- Understanding of the pharmaceutical product development process and involvement of CROs
- Able to work independently or in a team environment
- Good organizational and time management skills
- Working knowledge of PPD SOP & WPDs
- Able to organize competing priorities logically and review outstanding contractual risk and issues
- Able to effectively use automated systems and computerized applications
- Ability to demonstrate a customer focused style of communication, problem solving and collaboration Management Role: No management responsibility Working Conditions and Environment:
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Physical Requirements / Work Environment
Education- Bachelors degree or equivalent required.
Experience- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years)
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities- Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
- Demonstrated ability to apply basic principles of investigator grant negotiation
- General understanding of business and financial principles that related to service agreements
- Effective communication skills (verbal & written) in English and local language
- Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
- Demonstrated ability in attention to detail
- Excellent analytical and decision based thinking skills
- Understanding of the pharmaceutical product development process and involvement of CROs
- Able to work independently or in a team environment
- Good organizational and time management skills
- Working knowledge of PPD SOP & WPDs
- Able to organize competing priorities logically and review outstanding contractual risk and issues
- Able to effectively use automated systems and computerized applications
- Ability to demonstrate a customer focused style of communication, problem solving and collaboration Management Role: No management responsibility Working Conditions and Environment:
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Physical Requirements / Work Environment
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years)
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities- Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws
- Demonstrated ability to apply basic principles of investigator grant negotiation
- General understanding of business and financial principles that related to service agreements
- Effective communication skills (verbal & written) in English and local language
- Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters
- Demonstrated ability in attention to detail
- Excellent analytical and decision based thinking skills
- Understanding of the pharmaceutical product development process and involvement of CROs
- Able to work independently or in a team environment
- Good organizational and time management skills
- Working knowledge of PPD SOP & WPDs
- Able to organize competing priorities logically and review outstanding contractual risk and issues
- Able to effectively use automated systems and computerized applications
- Ability to demonstrate a customer focused style of communication, problem solving and collaboration Management Role: No management responsibility Working Conditions and Environment:
- Ability to work in an upright and /or stationary position for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
Physical Requirements / Work Environment
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Job posted: 2024-05-22
