Associate Director, US Medical Review Committee Operations
Alexion Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- 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.
- 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.
- 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