Associate Director Sampling Operations

Profile

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**MEMBERS ONLY**SIGN UP NOW***. aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer designed to improve the lives of millions.  We are on a ****rel=no-follow>mission to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.  We are looking for passionate and enthusiastic individuals who share our excitement for this mission.

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Summary Description

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We are currently seeking a qualified, highly motivated, experienced individual for the position of Associate Director – Sampling Operations located in our Brisbane, CA office and reporting to the Senior Director, Sales Operations. The Associate Director – Sampling Operations will own the PDRP-compliant drug sample programs for all franchises.  The successful candidate will partner closely with QA, Regulatory, Brand Marketing, Field Sales, Legal/Compliance and external vendors to support drug sampling programs for the Orgovyx and Myfembree franchises.

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Essential Duties & Responsibilities

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Responsibilities include but are not limited to:

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Operations:

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• Day to day oversight of Sample Management Vendor.
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• Ensure that all personnel that interact with sample programs are properly trained and up to date on all training for their role within the program. This includes compliance and operational aspects of PDMA and other state and federal regulations.
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• Partner with Veeva CRM team and the Sampling Management Vendor to enable appropriate technology for enhanced compliance and ease of use for the field teams.
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• Manage the process for onboarding and off boarding field sales reps with respect to sampling.
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• Lead cross functional team to identify sample losses, define root causes and implement CAPAs as needed.
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• Lead cross functional team to ensure adequate supplies of samples at all sampling DCs. This includes monitoring inventories, allocations and shipments and working with Marketing and Manufacturing to determine future demand.
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• Lead monthly meetings to facilitate discussion of sample inventory requirements with Sales Analytics, Finance, Marketing and Supply Chain.
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• Manage field communications around sample functionality and sample operations that include enhancement, compliance and operational communications.
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• Lead internal and external stakeholders to author and update SOPs, Business Rules and other sample operational and compliance documentation.
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• Partner closely with IT to ensure that all GxP-related considerations and sample operational needs are proactively managed as the Sales Operations team makes modifications to Veeva CRM
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• Partner closely with Sales Operations colleagues around sampling, Veeva CRM, analytics and Field Operations aspects of the drug sampling program
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Strategy:

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• Regularly work with Marketing, Sales, Compliance and QA to define the current objectives and strategy for every sample program.
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• Manage the sample programs to meet the short- and long-term objectives of the Marketing and Sales teams while staying compliant to Myovant Policy and SOPs. This includes managing and influencing both internal stakeholders and external vendors.
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• Ensure quarterly business reviews with Sample Management Vendor are timely and appropriate to the participants.
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• Ensure that Myovant’s drug sample program is compliant to all applicable state and federal regulations.
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• Lead timely meetings of the Sample Compliance Committee, responsible for agendas, documentation and content.
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• Work with IT on all GxP-related tasks as they pertain to the Sampling module in Veeva CRM.
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• Ensure sample product supply is adequate for the needs of the programs.
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 Core Competencies, Knowledge and Skill Requirements

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• Ability to effectively manage vendor partners.
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• Deep expertise in PDMA and other sample related regulations.
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• Strong interpersonal skills in order to lead without authority, interact with, focus, resolve conflict and drive consensus among individuals from a variety of disciplines and in matrix organization with an industry partner.
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• Ability to work with and coordinate requests from multiple internal and external customers.
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• Excellent communications skills with an ability to efficiently and productively communicate both verbally and in writing are required.
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• Proven project management skills, performance management, planning, prioritization, objective setting, meeting management and plan execution.
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• Ability to analyze critically and objectively to define and solve problems and to identify opportunities that meet overall strategic needs.
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• Clear history of exercising sound business judgment and clear decision-making.
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REQUIREMENTS (education and experience)

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• Bachelor of Arts or Bachelor of science in a related discipline, for the Senior Manager, will require a minimum of 8-10 years of experience with a bachelor’s degree or 6-8 years with a master’s degree. Associate Director requires a minimum of 10-12 years of experience with a bachelor’s degree or 8-10 years with a master’s degree, with a minimum 8-10 years of direct experience managing drug sampling programs in pharma or Biotech
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• Experience with DTP and hand-carry programs
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 Travel:

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• Ability to travel up to 15%
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The well-being and safety of our employees is our top priority. **MEMBERS ONLY**SIGN UP NOW***. requires all U.S. employees to be fully vaccinated against COVID-19 as a condition of employment regardless of location of role (field-based, fully remote or site-based). Fully vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. If you are unable to be vaccinated, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.

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Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

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Equal Employment Opportunity

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