MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.
We’re constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We’re pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we’re industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Contract Analyst ll
Primary responsibility will be to management and negotiations of Confidentiality Disclosure Agreements (CDAs) and Clinical Trial Agreements (CTAs) for the MedImmune Clinical Biologics Organization. This will involve working closely with Clinical Operations, Global Medical Development (GMD), Legal Affairs, Procurement, Finance and other departments as appropriate to ensure that outsourcing and contracting needs are met and handled in a manner that is consistent with both company requirements and good business practices.
The job will also involve providing input into the development and maintenance of clinical site budgets through the use of Fair Market value (FMV) industry benchmarking tools.
Major Duties and Responsibilities (including supervising others):
Provide overall management of CDA and CTA contracting activities within assigned therapeutic(s). Ensure agreements are generated in a timely manner according to department metrics.
Needs to meet
goals and objectives by:
Preparation of CDAs and CTAs for external parties and routing for signature.
Managing flow of negotiations to ensure proper review by legal and/or business stakeholders.
Receipt/entry of CDAs into Medi/AZ database in a timely manner
to facilitate and track the contract cycle time.
Responsibility for quality data entry into all databases in support of database
Review and contribute to departmental procedure documents related to site contracting development, as
Responsible for supporting/demonstrating compliance with established corporate standards.
Additional responsibilities as assigned.
Life cycle management of site contracts, including amendments
Work closely with project teams and other internal customers to negotiate costs and contracts with sites.
Development of FMV budgets.
Collaborate with parent company, Astra-Zeneca to recognize and implement business process, contractual, and/or financial synergies where appropriate.
Work with Legal Affairs as needed to develop and execute contracts in accordance with company standards.
Collaborate, build and maintain relationships with sites.
Minimum of a High School Diploma or GED with relevant industry experience; Associates Degree or equivalent work experience within industry preferred.
Minimum of 2 years of experience in clinical development and/or outsourcing and clinical contract negotiation and finalization within the pharmaceutical or biotechnology industry.
Can articulate the clinical study process and familiarity with medical/legal terminology.
Demonstrated understanding of the requirements of and for contracts that support the clinical development process.
Experience in complex contract and budget negotiation for clinical trials.
Demonstrates the ability to learn new computer based systems.
Heavy use and application of technical standards, principles, theories, concepts, and techniques in regard to e-database(s).
Demonstrates working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to it, together with an understanding of the ICH Good Clinical Practice (GCP) guidelines.
Demonstrates computer proficiency and the ability to develop advanced computer skills to increase efficiency in day-to-day tasks.
Understanding of contract/legal terms and ability to differentiate between legal vs. business risks.
Demonstrates flexibility and proficiency tracking work flow progress, supporting change management, collection of disclosure documentation, navigating an e-environment, and expense reporting. Will be responsible for prioritization of deliverables, timeline management across multiple therapeutic areas.
Possesses excellent interpersonal skills, written and verbal communication skills with attention to detail and follow up. Recommends procedural changes as appropriate based on department needs.
Ability to maintain a high degree of confidentiality
Demonstrates skills within databases, as well as a broad knowledge of computer software, including MS Office products. High proficiency in MS Word, Excel preferred.
Understanding of Good Clinical Practice and applicable regulatory and legal requirement governing conduct of clinical trials.
Understanding of the drug development process.
Can negotiate skillfully in tough situations with both internal and external groups.
Communicates with influence both orally and in writing.
Deals with ambiguity: can adapt plans quickly.
Accountability: shares ownership and visibility.
Team builder: defines success in terms of whole team.
Dealing with issues, managing diverse relationships.
Analytical and problem-solving skills.
Methodical and detailed approach.
Complex multi-project support activities with reasonable supervision, clear communication skills, comfort and proficiency working with contracts flow, databases and generating/optimizing tracking tools. Provides support to all types of clinical trials including global, high impact trials (e.g. pivotal trials).
Identifies problems and can propose and implement solutions that are practical and consistent with objectives and governance constraints.
Supervision required from Outsourcing Management.
Ability to prioritize work appropriately and work with some supervision.
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer.
AstraZeneca will consider all qualified applicants for employment without
discrimination on grounds of disability, sex or sexual orientation, pregnancy
or maternity leave status, race or national or ethnic origin, age, religion or
belief, gender identity or re-assignment, marital or civil partnership status,
protected veteran status (if applicable) or any other characteristic protected
only employs individuals with the right to work in the country/ies where the
role is advertised.
Website : https://www.astrazeneca-us.com
At AstraZeneca, we know your health is personal and that’s why we put careful consideration into determining the value and ultimately the cost of our medicines. Many factors go into these decisions such as the benefits our medicines provide to your health and their potential to reduce healthcare spending on other costlier medical procedures. Just as importantly, these decisions enable us to invest in discovering and developing future medicines where new treatments are needed. So how do we balance providing affordable access to our medicines while ensuring their cost reflects the value they deliver to the individual patient and broader healthcare system? We understand the weight of this question. That’s why we spend countless hours not just thinking about it, but finding new ways to help you and those you care about receive the best care possible for medical conditions we focus on. We do this by developing innovative medicines and offering programs that are uniquely tailored to you. We’re also always looking for ways to make your medicines more affordable and we collaborate with stakeholders across the healthcare system in pursuit of this goal.