IT Business Analyst, Medical Affairs

Job Title: IT Business Analyst, Medical Affairs Job Function: Project Manager Location: Raleigh, NC - Hybrid

USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.

As part of the USDM team, you have the opportunity to work with cutting-edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?

Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.

Nature and Scope of Job

We are seeking a highly motivated IT Business Analyst, Medical Affairs, to support our client on their digital technology needs, working closely with the Medical Affairs functions to deliver technology solutions that meet critical business needs. This role requires relationship management, business analysis, and project management skills, along with hands-on technical knowledge for solutions such as External Scientific Collaboration Management, OL Engagement, and Real World Data applications in Clinical Development.

Primary Responsibilities

Serves as a functional resource and subject matter specialist for Medical Affairs Information Management Systems
Collects, documents, and manages user, functional, and technical requirements for Medical information management systems for the Cell Therapy business areas.
Interacts with end users regularly to understand their needs and provide guidance and training on technical solutions.
Evaluate internal and external solutions to find the best fit.
Makes recommendations on business process automation and improvement with digital technologies.
Participates in system release and post-deployment support activities with Quality, System Owners, IT Security, IT Operations, and IT Service Desk.
Manages application configuration changes following IT Change Management (ITCM) and GxP Change Control procedures.
Provides day-to-day application support with managed service teams.
Troubleshoots technical issues and manages problems through to resolution.
Develops processes to ensure high availability of supported application systems.
Documents common resolutions/solutions and application support processes in the IT Service Management knowledgebase.

Qualifications

At least 8 years of experience working with medical affairs information systems.
Deep understanding of the late-stage clinical development and commercialization lifecycle with a specific focus on the Medical Affairs business domain/technologies enabling core functions such as external scientific collaboration management, Real World Data and their applications in clinical development as well as broad medical inquiry management, and field medical affairs.
Broad clinical development business and IT capability awareness and hands-on experience including global implementation experience with Veeva, Salesforce, iEnvision / Datavision, real-world data integration and related analytics, and medical platform-based solutions.
Deep understanding of security and privacy regulations, GDPR, internal/external Audits, and CAPA management and anticipate future technology needs.
Must possess excellent customer service, problem-solving, troubleshooting, and verbal/written communication skills.
Work experience and strong knowledge of end-to-end IT software and systems solution delivery from idea conception, design, development, and/or configuration, and transition into production support and maintenance.
Computer System Validation (CSV), and GAMP5 experience a plus.
Strong focus on process, continuous process improvement, and quality to enable innovation.
Proven track record of working in Agile (e.g., SAFe, Scrum, Kanban) and DevOps ways of working in the IT landscape.

Education & Certifications

A bachelor's degree in Information technology, Computer Science, or a related field of study.

Working Conditions

The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job and are not meant to be all-inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.

Unless reasonable accommodations can be made, while performing this job the staff member shall:

Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
Operate other office productivity machinery, such as a calculator, scanner, or printer.
Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Travel to client site for onsite work as needed.

Equal Opportunity Statement

USDM Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Disclaimer

This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs, as necessary.

Compensation

Salary/Hourly Rate Range (W2): USD 75.00 - 90.00

The base salary/hourly rate range represents the anticipated low and high end of the USDM’s compensation range for this position. Actual salaries/hourly rates will vary and will be based on various factors, such as the candidate’s qualifications, skills, competencies, and proficiency for the role. The compensation described above is subject to change and could be higher or lower than the range described based on market survey data or budget.

Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.

Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan. Full and part-time employees may be eligible for paid time off.

All employees are eligible for USDM's rewards and recognition program.

For more details about our benefits, visit us here: https://usdm.com/careers