Pay Rate: $30-40/hr Work schedule: Hybrid on-site (3 days in office).
Purpose: 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.
Responsibilities: Implements policies to support accurate, high quality and compliant medical and commercial
communications 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.
Education and experience: 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 preferred (PhD, RN, PharmD, RD).
1-2 years of experience for Level I and 3-5 years of experience for Level II.
Top skill requirements: Health related background, BSN/PharmD, with1-5 yrs of Pharma experience ideally).
Experience with the application of FDA OPDP regulations, guidance regarding Advertising and Promotion (a plus would be for international regulations experience).
Ability to review and monitor Medical Materials: scientific information to meet standards for pharmaceutical promotion/scientific exchange.
Can help to develop/provide input on supplemental training for medical reviewers for US/OUS audiences.
Ability to work on updating SOPs across the business.
Experience in medical review experience preferred, but not required.
Ability to influence others without direct authority.
Previous experience in situations of conflict resolution, problem solving or crisis management
preferred.
Interpersonal and relationship building skills.
Able to operate effectively within a matrixed environment, embrace change, and lead
implementation of new initiatives.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions.
To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity,
national origin, disability, or status as a protected veteran.