Global Development and Scientific Materials Review Manager, Worldwide Medical Operations

This individual will work directly with and across multiple functions of the organization including but not limited to: Global Scientific Partners consisting of Scientific Communications, Congress and Medical Information as well as Global Medical Directors, Legal, Regulatory, and external vendors.

This individual will be responsible for managing materials through its lifecycle from concept through approval. Specific activities include managing the monthly planning and forecasting of materials, facilitating cross functional review meetings, ensuring timely completion of materials through the workflow, confirming all required stakeholders are engaged in the review process, validating adherence to company policy.

They must have strong communication skills, the ability to manage many projects at the same time whilst keeping within priority deadlines. They should have a solution oriented mind set and be able to find efficiency improvement opportunities. They will need to build and manage relationships across various functions and levels within the organization. This individual must be able to work in an ambiguous environment where responsibilities may change based on business need.

Responsibilities may also include quality medical fact checking, reference management, generating monthly process health metrics and participating in cross functional process improvement teams. Candidate will also serve as the primary point of contact for end user training, system set up, and support.

Responsibilities

• Provide operational/workflow management and support to the Global Medical function
• Manage the life cycle of materials in the technology platforms leveraged by the Global Medical Team
• Quality control of Global Medical materials
• Liaise with content development and DSMR support vendors
• Manage DSMR guidance materials
• Create/Maintain intranet page for DSMR teams
• Identify and participate on process improvement teams
• Partner with US and EU+ Coordinators to communicate downstream material forecasting and planning
• Ad hoc projects as requested

Skills and Competencies

• Build solid relationships based on trust and strong ethics
• Customer focused perspective with business enablement at the forefront
• Strong oral and written communication as well as organizational skills with the ability to multi-task and coordinate multiple activities in parallel
• Anticipate and adapt to change while maintaining accountability
• Take initiative, work independently yet engage in collaborative decision-making initiatives
• Agilely work by completing tasks in a timely fashion, and function in a rapid-paced environment
• Manage and prioritize multiple and varied tasks efficiently and accurately
• 3-5 years working in the biotech/pharmaceutical or compliance driven environment a plus• BS/BA

Reporting to the Senior Manager, Worldwide Medical Operations, this role is responsible for the day to day management of the business-critical Development and Scientific Materials Review (DSMR) process for Global Medical.