Sr. Mgr. Sample Accountability

Location
Sleepy Hollow, New York, US
Posted
Sep 24, 2018
Ref
13879BR
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary
The Senior Manager, Sample Accountability role is a leadership role responsible for ensuring that the Regeneron Sample Program is run in a manner compliant with external PDMA and state regulations and with internal Compliance and Sampling SOPs.

The individual in this role will have overall responsibility for the Accountability aspects of Regeneron sample programs, working closely with third party vendors and partnering with key stakeholders to ensure compliance in the development and operations of said programs.

Responsibilities

• Provides leadership and guidance to the Sample Accountability Specialist(s) responsible for day-to-day accountability and front-line field support.

• Serves as a subject matter expert and provides guidance on potential sample compliance matters to commercial management, third-party vendors and internal stakeholders

• Serves as the key escalation point for matters related to sample accountability aspects of the Regeneron Sample Program for commercial management, third-party vendors as well as Legal and Compliance.

• Continuously monitors productivity and makes suggestions for changes/improvements to existing systems and processes, and initiates new procedures that may increase efficiency.

• Provides guidance to management on potential process improvements, compliance matters and their potential impact on organizational effectiveness and business success.

• Works with relevant internal groups to lead the development of meaningful metrics and reports surrounding the Program. Ensures patterns and exceptions are presented to management and makes recommendations for change as appropriate.

• Leads the development of work instructions and policies and procedures covering accountability aspects of the Regeneron Sample Program.

• Leads the development of processes and programs to regularly review and audit the Regeneron Sample Program to ensure third party vendors are consistently adhering to business rules and are in compliance with all company policies and procedures and government regulations.

• Leads efforts to enforce the Regeneron sampling policies with Field-based associates.

• Collaborates with the Compliance and Training Departments to ensure Field-based personnel receive initial new hire and annual PDMA training on schedule.

• Works closely with other internal departments to ensure that any changes in the Sample Program are made in alignment with other policies, procedures and system maintenance agreements.

Requirements

• Bachelors degree required.

• Demonstrated ability to manage process improvement initiatives, identifying gaps and creating solutions to complex problems, implementing quickly and successfully.

• Strong organizational, planning/project management.

• Extensive experience managing multiple projects against stringent deadlines concurrently.

• Strong leadership skills

• Highly effective influencing skills.

• Proven ability to lead and motivate staff.

• In-depth experience of effectively managing vendor-partner relationships.
o Ability to maintain professionalism under stressful or adverse conditions

• Excellent oral and written communication/diplomatic skills with the ability to communicate effectively at all levels within and across the organization.
o Strong Microsoft Outlook, Word and Excel skills are required

Required Special Equipment and/or Programs:

• 5+ years of sample accountability / PDMA and sample operational experience, or an equivalent combination of education and experience.

• Comprehensive understanding of Prescription Drug Marketing Act with general knowledge of cGMP, OIG, FDA and other regulatory requirements associated with sample programs.

• Direct experience managing cold chain direct-to-physician sample programs #LI-PD1

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid. #LI-RE1

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.