Biocon Biologics
JOB DESCRIPTION RESPONSIBILITIES: PRC (MLR) MANAGEMENT
• Coordination and management of the Canada Promotional Review Committee (PRC) /Medical, Legal, Regulatory (MLR) Promotional Review & Approval including:
• Planning, submissions, reviews, meetings, and adherence to review timelines.
• Manage cross-functional promotional review PRC meetings:
• Build and manage meeting agendas.
• Drive meetings while annotating PRC Reviewer comments.
• Facilitate productive meeting discussions.
• Manage meeting logistics and outcomes.
• Partner with product owners, agencies, external partners, and internal COE (center of excellence) to support development of promotional materials adherent to appropriate PRC standards and timelines.
• Provide input on key policies and procedure documents (i.e., Commercial PRC SOP, Material Destruction & Repossession SOP, related work instructions/job aids, etc.).
• Coordinate with project owners on operational updates including policy updates, expirations, recall, destruction of approved materials, etc.
• Expert on Veeva Vault and process providing onboarding/training, coaching, and troubleshooting with commercial team and third-party vendors.
• Testing and activation of digital details and emails between the PRC and CRM systems.
• Build, provide and capture monthly metrics/KPI reporting for PRC.
• Perform special projects and other management-related duties as assigned.
• Support U.S. PRC, as needed. PRC (MLR) EDITING
• Proofreads and edits submissions, within Veeva Vault, for spelling, punctuation, grammar errors, and format/style inconsistencies.
• Ensure projects comply with applicable industry and FDA regulations.
• Verifies Medical, Legal, Regulatory feedback has been properly pulled-through.
• Fact checking.
• Knowledgeable about Canada promotional use and review guidelines, U.S.
FDA regulation knowledge helpful, for promotion of prescription of drugs.
• Fluency in review of digital, interactive, tablet, and print tactics targeted to a variety of audiences, including healthcare professional, consumer, and corporate.
• Strong time management skills: able to work quickly without sacrificing accuracy.
• Proactive and able to prioritize, research, and problem-solve without guidance.
• PRINT/FULFILLMENT • Vendor management and print/fulfillment service for Canada marketing and sales teams • Owns and manages marketing print fulfillment budgets and coordination to support business objectives and provides recommendations for cost savings.
• EVENTS AND MEETINGS MANAGEMENT • Assist in the coordination of congress, trades show, etc. logistics, as needed • Manage vendors and required compliance approvals for the commercial marketing and sales teams.
• PROCURMENT/FINANCE COMMERCIAL PROCESSES • Help guide and provide clarity on how to execute requests for Purchase Orders (POs), Statement of Works (SOWs), Master of Service Agreements (MSAs), Confidential Disclosure Agreements (CDAs), Letter of Agreements (LOAs), HCP and association engagement agreements, invoicing, etc. • Partner with Procurement, Finance, Legal, and Compliance on the troubleshooting of issues, when necessary.
REQUIREMENTS
• A bachelor’s degree (or equivalent) and a minimum of 3 years of Canada PRC experience for pharmaceutical/biotech companies required; additional U.S. PRC experience helpful. However, a combination of experience and/or education will be taken into consideration.
• Must possess strong knowledge of marketing/sales, marketing services/operations, project management, event management, policy development, management, and PhRMA guidelines.
• Marketing operations, project management, and print/fulfillment coordination experience required.
• Experience in maintaining relationships with various external partners and vendors.
• Must be able to multi-task and prioritize responsibilities while interacting with key department stakeholders and external partners.
Must adhere to project timelines and deadlines. Must maintain and deliver budget analysis for a variety of programs. Works on data with an eye for accuracy, problem-solving, and teamwork.
Must demonstrate the ability to learn new tasks and implement change when required. Must have strong organizational skills. Excellent oral and written communication skills.
Strong negotiation skills. Computer proficiency using Microsoft Office (Word, Excel, and PowerPoint).
• Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence.
Ability to work with peers and communicate basic concepts.
• May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms to lift and scoop. May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically pushing, rolling, or lifting.
May be required to wear personal protective equipment including but not limited to respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing. Medium lifting requirements.
• Bilingual proficiency in speaking, comprehending, reading, and writing in French Canadian and English required.
• Remote Canada / US-based position (Canada-based acceptable) with up to 10% travel.
Biocon Biologics is an Equal Opportunity, EEO / Affirmative Action Employer committed to excellence through diversity. All qualified applicants will receive consideration for employment without regard to, and no employee shall be discriminated against because of their race, color, religion, age, sex (including pregnancy), national origin, disability, genetic information, status as a protected veteran or any other characteristic protected by applicable federal, state or local law.
