Medical Reviewer/Safety Reviewer I/II at Randstad USA

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!

 
location: North Chicago, Illinois
job type: Contract
salary: $32.21 - 39.83 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:

Reporting to the Executive Director, Global Material Review, Medical Compliance Excellence, the Global Material Review, Medical Compliance Excellence is accountable for compliance monitoring supporting the scientific development and review of medical content of Company promotional and non-promotional materials for marketed and investigational products. This role is responsible for ensuring that presentations of medical and scientific information meet standards for pharmaceutical promotion and scientific exchange. This role is responsible for building positive and collaborative relationships in matrixed and cross-functional team environments incorporating diverse groups from Global Affiliates, therapeutic area teams, Regulatory Affairs, OEC, and all functional areas of Global Medical Affairs.

• Implements policies to support accurate, high quality and compliant medical and commercial communications for AbbVie Globally through active monitoring of approved materials. Actively pursues updates to guidance on regulations and internal policies and their impact on promotional and non-promotional material review processes and procedures.
• Responsible for the review and reporting of compliance performance KPIs and related compliance monitoring for material review to mitigate business performance risks.
• Ensures Medical Affair employees complete required training to do their jobs through development, maintenance, and reporting of role-based training plans.

 
qualifications:

• Bachelor's degree with related health science background: BSN, BS, BS Pharm. Advanced degree or extensive experience in operations and/or performance (commercial/customer) excellence is preferred (PhD, RN, PharmD, RD).
• Level I =1 - 2 years' experience, Level II = 3-5 years of experience
• Experience in medical review experience preferred, but not required.
• Ability to influence others without direct authority.
• Excellent leadership, self-management and organizational skills; able to manage workload, set personal and team priorities and adjust as needed
• Previous experience in situations of conflict resolution, problem solving or crisis management preferred.
• Excellent interpersonal, communication (both oral and written), and relationship building skills.
• Able to operate effectively within a matrixed environment, embrace change, and lead implementation of new initiatives; can decide and act without having the total picture and can comfortably handle risk and uncertainty.

 
skills: FDA, MS-WORD, MS-EXCEL, SAE (Serious Adverse Event), ICH Regulations, AD (Adverse Events)

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.