JobWatch

1+ months

REMS Program Manager

Kelly Services
Foster City, CA 94404
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **REMS Program Manager** at a prestigious Fortune 500 company working in **Foster City.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: REMS Program Manager**





**Pay: $61 per hour**





**Duties**



Contractor, Standards & Collaborations (S&C) within Global Patient Safety (REMS Program Management and Solicited Program Management)


**Essential Job Duties and Functions**

Utilizes strong operational and project management skills to manage or provide support for the operational aspects of Risk Evaluation and Mitigation Strategies (REMS) programs for Global Patient Safety

Manages or provides support for ongoing REMS program commitments/department-wide initiatives by collaborating with key stakeholders including but not limited to, Regulatory, Global Patient Safety, Commercial, Medical Affairs, Legal, IT and external vendors

May be responsible for internal and cross functional team representation and participate in cross functional projects as required including areas related to regulatory submissions for REMS programs per standard procedures

Contributes to managing implementation related activities for REMS including but not limited to: website and print material verifications following FDA approval of an initial REMS or program modification to ensure compliance

Assists with periodic training of REMS vendors and specialty pharmacies on adverse event (AE) reporting process and REMS-specific requirements to ensure REMS vendors adequately perform their contractual activities

Ensures personal compliance with internal processes to meet all applicable internal/external reporting requirements for Global Patient Safety and REMS

Supports training and/or on-boarding activities, preparation and training materials for staff and vendors

May support or manage activities related to solicited program management (e.g. Market Research, Patient Assistance Support Programs, and Digital Media), which can include training, reconciliation, and/or compliance monitoring

Works with applicable teams within Global Patient Safety, other functions, or external vendors to implement and maintain activities or tasks under the remit of S&C

Supports cross-functional projects and may serve as a point of contact to other functions in the organization and outside the organization

Understands and manages the execution of Global Patient Safety Business Continuity processes, as applicable

Excellent interpersonal and communication skills, both written and oral

Strong organizational skills and ability to adapt to changes

Strong computer skills in Microsoft Excel, Word, and PowerPoint

Experience in training delivery and project management preferred

Experience with managing vendors, partners including specialty pharmacies, external PMOs highly preferred


**Manager/Project Management skills preferred**

Demonstrates initiative, teamwork, and accountability

Excellence at resolving complex, interdependent activities into tasks and sub-tasks that are documented, monitored and controlled

Works in partnership with project leaders to ensure timely, efficient, and effective moderation of meetings, and to ensure adequate progress on team activities between meetings

Co-Chairs Project Team meetings and is responsible for coordinating moderately complex team operations and communications

Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status

Organizes Project Management support for various functional areas on the Project, attends sub-team meetings as necessary; organizes ad hoc working groups

Ensures that Development Plans optimize the integration of timing, scope and resources

Represents the Project Team or Working Group team to the Global Patient Safety Leadership or Program Steering Committee. Organizes preparation of moderately complex documents and/or procedures for review by the Global Patient Safety Leadership or Program Steering Committee for projects within Global Patient Safety


**Eligibility Requirements**

7+ years of relevant experience with BA/ BS

5+ years of relevant experience with MA/ MS

A scientific background or experience in pharmacovigilance and/or REMS preferred.







**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**










**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2020-07-01 Expires: 2020-08-13

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REMS Program Manager

Kelly Services
Foster City, CA 94404

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