Global Delivery Manager, Remote

Job Description

As the Global Delivery Manager, you are responsible for the coordination of all global publishing deliverables with the vendor(s), in line with the strategic direction of their assigned programs/products. You will act as the primary point of contact with the vendor and for regulatory functions (i.e., IGM, CMC, Development, and Labelling) as appropriate in the products lifecycle. You will also partner with planning and tracking to ensure submission deliverables are incorporated and visible to all stakeholders as well as ensure hand offs and deliverables from authoring community are on time in line with the submission standards and expectations of quality. You support the development of deliverable timelines with Regulatory Submission Manager and authoring community and advise on appropriate standards and expectations of quality. You will identify and raise visibility of agency guidance updates relevant to submission sciences, and support innovative process change for improved efficiency.

· Oversee publishing deliverables on a day-to-day basis to ensure successful execution of operational activities for assigned Submissions.

· Coordinate and track delivery of required content with content owners for routine / maintenance submissions in global markets.

· Support quality of submission build - advise on submission standards and ensure vendor compliance with standards.

· Responsible for understanding and communicating impact of industry changes relevant to submission sciences, and supporting innovative process change for improved efficiency.

· Assist functional leadership to collect data against defined targets (e.g., collect and measure KPIs, performance metrics data). Gathering of data and entering onto trackers / etc. Promote awareness of Regulatory Information Management Strategies.

· Responsibility in a supporting capacity for specific initiatives / relationships, as well as process efficiency / improvements

Qualifications

· SME in eCTD, global submission guidelines

· 4+ years regulatory operations experience

· SME in regulatory operations processes

· Strong communication and project management abilities in global and virtual teams

· Bachelor’s Degree (life sciences preferable, IT/Business acceptable)

· Vendor management experience beneficial

Additional Information

The Submission Sciences/Regulatory Operations team at Biogen is searching for an energetic and motivated professional to support the delivery of timely and quality submissions to global regulatory authorities for both major submissions and lifecycle management.

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.