Project Manager, Science and Regulatory Affairs at Biotechnology Innovation Organization

Washington, District of Columbia, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Oct, 26

Salary

130000.0

Posted On

14 Jul, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Program Management, Drug Development, Budget Management, Risk Mitigation, Stakeholder Coordination, Clinical Stage Program Management, MS Project, SharePoint, Regulatory Affairs, Technical Solution Implementation, Process Improvement, Strategic Planning

Industry

Biotechnology Research

Description

Biotechnology Innovation Organization (BIO) is the world’s largest advocacy association representing member companies, state biotechnology groups, academic and research institutions, and related organizations across the United States and in 30+ countries. BIO members are involved in the research and development of innovative healthcare products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. The Project Manager, Science and Regulatory Affairs, drives the organization, tracking, budget and timing of priority, often cross-functional deliverables in the Science and Regulatory (SciReg) Strategic plan. He/She will ensure SciReg objectives are met on time, within budget and with clear results.  Using program management tools and technical expertise and/or broad experience in drug development, the Project Manager, will partner with the SciReg team to execute on the strategic plan and budget, with direct responsibility for the day-to-day, cross-functional execution. primary Responsibilities * Planning, Documenting and Tracking: Facilitates achievement of BIO Science and Regulatory goals by proactively planning and tracking tasks, documenting meeting outcomes including actions and decisions, and monitoring ongoing progress of deliverables. * Governance and Continuous Improvement: Ensures key recommendations flow through the Core Team, various Matrix Teams, and appropriate governance committees in the right order to ensure vertical and horizontal integration across functional areas and senior management. Identifies and analyzes problems, and recommends solutions as part of continuous improvement * Logistical coordination: Manage Science & Regulatory Committees, Task Force or Work Group logistics, documentation and coordination to advance BIO’s science and regulatory agenda. Manages coordination of Science & Regulatory deliverables across large stakeholder meetings throughout the year (Board Meetings, Convention, Leadership Summit etc.) * Communication: Ensures effective, accurate and timely communication of key issues and progress to the team members, and other functions or committees as appropriate. * Budget Management: Work closely with functional leads/business owners to maintain spend levels in line with board-approved budget, support contract request process from teams as needed to ensure requests align with program priorities and approved budget. * Risk Identification, Mitigation and Communication: With the Lead(s) identify potential risks, develop and execute mitigation plans and communicate these in a timely fashion to the cross-functional team and the Lead. * Implement Technical Solutions to Enhance Science and Regulatory Impact: Lead the implementation of technical solutions to take disparate Science & Regulatory work product (i.e. White Papers, Positions, advocacy tools etc.)and provide central communication internal and external as well as enable the use of AI for efficiency where appropriate. qualifications EDUCATION and certifications * BS/MS in life sciences required; Advanced degree (MBA) preferred. * PMP certification preferred. Experience * Minimum of 5 years of relevant program management experience in drug development managing clinical stage programs (Ph 1 – 3). * Other functional experience in drug development preferred (e.g.Clinical Operations, Regulatory Operations, Technical Operations, etc.). Knowledge, SKILLS, AND ABILITIES (KSA’s) * Experience in New Drug Application submissions and approvals a plus. * Facility with tools and technology including MS Project/Powerpoint/Excel, SharePoint, teleconferencing platforms required * Experience building IT platforms to enable workflow preferred * Website design experience a plus * Experience with Process/program management required physical requirements * Sitting/Standing: Remaining in a stationary position for extended periods (sitting at a desk, standing at a counter).  * Reaching: Reaching for items on shelves or in cabinets.  * Lifting/Carrying: Moving boxes, files, or other office equipment up to 15 pounds. * Using Hands/Fingers: Operating a computer, keyboard, mouse, and other office equipment.  * Vision: Close vision for computer work and detailed tasks.  * Fine Motor Skills: Using a mouse, keyboard, and other small office tools.  travel requirements * Ability to travel locally or regionally 10% as job duties require work environment * Hybrid This job description is not intended to be all-inclusive, and responsibilities can be expected to evolve over time to meet changing business needs. The employee may be required to perform other related duties to meet these needs. While BIO’s intent is always to be clear and transparent about the expectations of this role, this job description may be reviewed and updated accordingly with or without notice. BIO is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity, or any other protected characteristic under federal, state, or local law. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Responsibilities

The Project Manager drives the organization, tracking, and budget of priority deliverables within the Science and Regulatory Strategic plan. This includes managing committee logistics, ensuring cross-functional execution, and implementing technical solutions to enhance advocacy impact.