Associate Director, Us Medical Review Committee Operations

Associate Director, US Medical Review Committee Operations

This is what you will do:

The position of Associate Director, US Medical Review Committee (MRC) Operations is responsible for the overall implementation of strategic and complex projects within the US Medical Review organization and cross functionally. The Associate Director is responsible for all oversight and day-to-day operations associated with medical, legal, and regulatory review of non-promotional materials. Collaborate with therapeutic area US Medical Affairs teams, Regulatory, Legal, Compliance, and Medical Communications to ensure best practices, long-term planning, quality, and compliance with policies and standard operating procedures (SOPs). This includes coordinating and collaborating with the Medical, Legal and Regulatory leadership on execution of core projects, system enhancements, and operations related to vendor oversight and management. Guide and coordinate external agencies and vendor activities to ensure effective and efficient adherence to established SOPs. Develop and manage all applicable SOPs, working practices/instructions, training materials and ensure that all applicable MRC team members are trained accordingly.

You will be responsible for:

• Providing oversight of US Medical Review Committee (MRC) process including maintaining system, training, management of coordinator, Standard Operating Procedures (SOPs)
• Assisting with project planning, development, and maintenance of departmental Policies, Standard Operating Procedures (SOPs); Work Practice Documents (WPDs); and related training materials (e.g., training matrices, training modules, learning management system training assignments) for all departmental, contracted and vendor employees.
• Developing and delivering durable and live trainings, including interactive training modules
• Interacting effectively and collaboratively with therapeutic area Medical Affairs teams, Medical Communications, Compliance, Legal, Regulatory, and other MRC stakeholders
• Working collaboratively with US Promotional Review Committee (PRC) Operations team to support tactical planning process to consolidate database and process enhancements and to coordinate training requirements.
• Assisting in executing tactical deliverables identified during US Medical Communications objective setting and based on departmental strategic imperatives.
• Assisting with budget planning, forecasting, accruals
• Overseeing the development and execution of departmental dashboards, metric reports, tracking, departmental communications to cross-functional partners (e.g., Global Medical Affairs; MRC team members), and departmental project plans.

You will need to have:

• Bachelor’s Degree
• 2+ years of commercial or medical affairs operational experience; or project management experience within the biotech/pharmaceutical/device industry
• Excellent verbal and written communication skills as well as strong interpersonal and tactful negotiation skills
• Project management skills with proven ability to prioritize, conduct, and meet project deadlines.
• Operational management experience with ability to determine essential components of requirements in order to include them in applicable policies, standard operating procedures (SOPs), working practice/working instructions, and training materials.
• Effective organizational and time management skills
• Demonstrated ability to implement projects of strategic importance, including managing multiple projects simultaneously.
• Demonstrated success in delivering projects on time, within budget, and in accordance with strategic imperatives.
• Proven ability to exercise problem solving and strategic thinking skills; and has foresight and judgment in making complex decisions.
• Flexibility, the ability to adapt to changing project scope and direction; particularly as projects require strategic thinking and solutions.
• Self-motivated to drive for results, with strong organizational and planning skills.
• The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have:

• Doctor of Pharmacy Degree (PharmD) or Scientific/Medical Degree
• 5+ years of biotech/pharmaceutical/device industry experience
• Experience with Veeva Vault (Veeva MedComms / Veeva Promomats) digital asset management system
• Experience configuring/managing a database and working and partnering with IT colleagues to implement solutions
• Mastery of specific Project Management methodologies a plus (e.g., Lean, Six Sigma, PMP certification, etc.)
• Experience working in Medical Review Committee Operations
• Experience developing Policies, Standard Operating Procedures (SOPs), Work Practice Documents, etc.
• Experience leading upgrade, implementation, or migration of new system/software