Job Description

Job Description

A successful Senior Manager of Expanded Access Programs must have a deep knowledge of program management skills and process optimization principles. They must have a strategic mindset as well as be able to lead and develop without direct authority and be able to lead a cross-functional group of stakeholders. They should be proactive, work independently, with guidance in only the most complex situations. They will have accountability for the SOPs, process maps and associated team and vendor metrics, reporting & publishing. They need to have audit experience and remediation implementation. The candidate should be able to execute on business plans, contribute to the development of the team strategic initiatives. They will also need to be able to manage, problem solve and address issues with impact beyond the EAP team and utilize knowledge and expertise of related disciplines.

Additional Responsibilities Include:

* Plan, design and execute Early Access Programs according to the strategic objectives of the organization needs for each therapeutic area in collaboration with cross-functional teams
* Execute EAP planning from start to completion, including procurement processes, slide-development, timelines, milestones, processes, budget and operations (SOPs/WIs, metrics) are published and maintained accordingly
* Prepare and implement strategies to monitor program performance and determine the need for operational and strategic improvements and document according to knowledge management principles
* Prepare strategic presentations and apply change, risk and resource management principles when needed to EAP programs. Ensure appropriate vendor management utilization, tracking and reporting.
* Ensure all appropriate processes and procedures are followed and thorough audit readiness, remediations and close out on any CAPAs documented accordingly.
* Ensure program operations and activities adhere to legal guidelines and internal policies
* Keep senior management informed with detailed and accurate reports or presentations
* Manages professional employees, supervisors or lower level managers; has accountability for the budget, performance and results of teams
* Addresses issues with impact beyond own team based on knowledge of related disciplines
* Applies best practices and knowledge of internal/external business challenges to improve products, processes or service

Qualifications

* Requires a Bachelor's Degree (Masters preferred) and 7-10 years of Early/Expanded Access Programs (EAPs) professional experience, CRO experience additionally is a plus
* Experience leading within a matrix organization and appropriate multi-stakeholder management at different levels of seniority
* Thorough understanding of project/program management techniques and methods
* Excellent Knowledge of performance evaluation techniques and key metrics
* Outstanding knowledge of data analysis, reporting and budgeting
* Working knowledge of MS office and program management software (e.g. Basecamp, MS Project etc.)
* A business acumen with a strategic ability
* Excellent organizational, working in a team and leadership skills
* An analytical mindset with great problem-solving abilities and flexibility in thought
* Excellent communication skills
* Excellence in process work, document review,
* Experience in audit remediation,
* Requires specialized depth and/or breadth of expertise in own job discipline or field

Additional Information

Biogen is hiring an experienced Senior Manager, Expanded Access Programs to execute a wide range of EAP programs as part of the Global EAP team. The candidate will be responsible for the delivery and reporting of overall success of each program. This role will be based in Cambridge, MA.