This role can either be Manager or Sr Associate level depending on expereince. It is responsible for managing all aspects of the business-critical Development and Scientific Materials Review (DSMR) process for all products in the US Affiliate, ensuring that all our reviews are done in compliance with our standard operating procedures.

As an expert in the process, SOPs, system, complex internal and external concepts that enable and drive materials review, this role chairs the medical, legal and regulatory review committee, builds consensus, solves complex problems, manages the review process from end to end, provides training and expert advice to users and experts from diverse functions, to DSMR colleagues in Global and International, and to the IT support team to drive continuous improvement of the system and related processes.

The role is autonomous, requiring limited guidance and with the expansion of our therapies beyond MS & SMA, this role will also manage an external coordinator. This individual needs to have a strong sense of responsibility, willingness to go the extra mile during critical peak workload periods, juggle many competing tasks and at the same time keep continuous improvement projects running.

Knowledge of related processes in other functions or regions is required to ensure that continuous improvement projects are of benefit to and do not conflict with them.

Responsibilities

• Manages all aspects of the development and scientific material review process in the US to ensure the high volume of content is medically appropriate, accurate and consistent with all applicable regulations, laws and Biogen SOPs.
• Works closely with US marketing, regulatory, medical, legal, GCO, Patient Advocacy and other cross functional stakeholders to drive an efficient and compliant review and approval of all non-promotional materials.
• For new material types and complex projects for both Global and US materials, chair a concept review and ensure a timeline decision on path forward. Record all decisions as reference for the future and (when the SOP allows) document in the appropriate SOP or Work Instruction.
• As owner or major team member of projects, drives continuous improvement of review and approval processes, systems, SOPs and documentation.
• Defines user requirements and works with the IT Vault Support Team to enable development of the best system solution to meet the requirements.
• Onboards new staff and functions into the materials review process and systems, adapting to special needs at the same time as driving consistency with existing processes.
• As subject matter expert of this area, provides training, support, advice and guidance to users and experts across different functions, including DSMR peers in Global and International. This last with a view to advising on best practices, harmonizing and streamlining currently diverse workflows and processes across the world within regulatory limits.
• Provides in-depth analytics on the materials review process to drive strategic improvements.
• Back-up Project Manager of all materials as a package for Congresses as needed.
• Liaise with content development and DSMR support vendors

#LI-CL1

• 5+ years working in the biotech/pharmaceutical or compliance driven environment, 7+ years for Manager
• Project Management qualification a plus
• Experience using VEEVA VAULT (MedComms or Promomats)
• Organizational skills to be able to manage and prioritize multiple and varied tasks efficiently and accurately
• Agilely work by completing tasks in a timely fashion, and function in a rapid-paced environment
• Strong oral, written and presentation skills with ability to explain complex concepts clearly to a variety of audiences and gain consensus in complex situations
• Ability to build and manage relationships across various functions and levels within the organization based on trust and strong ethics
• Customer focused perspective and strong sense of responsibility required
• Take initiative, work independently yet engage in collaborative decision-making initiatives requiring the ability to think strategically
• Solution-oriented and efficiency improvement mindset
• Must be able to work in an ambiguous and complex environment where responsibilities may change based on business need and urgent requests need to be acted on quickly

Education:

• BS/BA, or High School Diploma and > 5 years in a similar or quality/compliance role

All your information will be kept confidential according to EEO guidelines.

As an expert in the process, SOPs and systems that drive materials review, this role chairs the medical, legal and regulatory review committee, builds consensus, solves complex problems, manages the review process from end to end, provides training and expert advice to users and experts from diverse functions, to DSMR colleagues in Global and International, and to the IT support team to drive continuous improvement of the system and related processes.