Project Manager 1, Medical Writing

BioSpace; Kansas; Hybrid; USD 90,000 - 140,000; Full time

Job summary

BioMarin is seeking a Project Manager for Global Medical Writing to manage drug development programs from early stage through post-approval. You will coordinate cross-functional teams across Clinical Development, Regulatory, Data Sciences, and Safety to ensure program success.

The role emphasizes detailed scheduling, risk management, and data-driven decision making, with potential mentorship of junior staff within a dynamic, globally focused team.

Qualifications

• 3–6 years of work experience in drug development with 1–3 years of direct project management experience in early and/or late stage clinical development.
• Ability to drive, motivate and enable effective team meetings and high performing teams, while developing and maintaining professional interpersonal relationships with colleagues
• Strong documentation, organization and time management skills in a fast-paced environment
• Experienced with Project Professional software
• Minimum: Bachelor’s (BS/BA) in Biological Sciences or closely related field

Responsibilities

• Responsible for project managing programs from early stage to post-approval for the Global Medical Writing organization.
• Facilitates the integration of all key workstreams supporting the product.
• Drives collaboration and transparency, while influencing the team’s critical thinking with inclusive strategic planning.
• Develops detailed project schedules that integrate key activities, timelines, and tracks the critical path for assigned projects.
• Develops, independently and as part of a team, decision-making methodologies, tools, and solutions for the Global Medical Writing organization to identify complex issues with cross functional mid- to long-term project- and program-level impact.
• Manages project risk assessment and reporting to applicable stakeholders.
• Responsible for ensuring and analyzing accurate budget and resourcing requirements are maintained within Global Medical Writing, and escalating change or out of scope requirements.
• Partners with the Head of Global Medical Writing to schedule as-needed departmental Governance meetings to discuss strategy, emerging data, budget/resourcing, and align on data-driven decisions.
• Manages SharePoint Team Collaboration Sites and associated dashboards for the Global Medical Writing alignment and communication.
• Maintains Global Medical Writing OKRs (Objectives and Key Results), keeping the team on track and communicating change, risk and impact.
• May mentor and/or supervise junior staff.
• Other duties as assigned.

Skills

Project management

Team leadership

Documentation

Time management

Interpersonal communication

Education

Bachelor’s degree in Biological Sciences or related field

Tools

Project Professional

Microsoft Excel

SharePoint

Power BI

Microsoft Teams

Job description

This role has a preferred candidate however all are encouraged to apply.

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options.

More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research And Development

From research and discovery to post-market clinical development, our R&D engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.

This individual project manages drug development programs for the Global Medical Writing organization that range from early-stage through post approval phases for clinical development. This individual will identify and manage project-related priorities; maintain and track high-quality integrated project plans and dashboards to enable accurate reporting and decision making; enable effective team meetings and high-performance teams; manage risk assessment/escalation; develop strategies for monitoring progress and for intervention/problem-solving in collaboration with stakeholders. The Project Manager interacts with individuals within Global Medical Writing as well as across all departments ranging from Clinical Development, Regulatory, Data Sciences, and Safety.

Responsibilities

• Responsible for project managing programs from early stage to post-approval for the Global Medical Writing organization.
• Facilitates the integration of all key workstreams supporting the product.
• Drives collaboration and transparency, while influencing the team’s critical thinking with inclusive strategic planning.
• Develops detailed project schedules that integrate key activities, timelines, and tracks the critical path for assigned projects.
• Develops, independently and as part of a team, decision-making methodologies, tools, and solutions for the Global Medical Writing organization to identify complex issues with cross functional mid- to long-term project- and program-level impact.
• Manages project risk assessment and reporting to applicable stakeholders.
• Responsible for ensuring and analyzing accurate budget and resourcing requirements are maintained within Global Medical Writing, and escalating change or out of scope requirements.
• Partners with the Head of Global Medical Writing to schedule as-needed departmental Governance meetings to discuss strategy, emerging data, budget/resourcing, and align on data-driven decisions.
• Manages SharePoint Team Collaboration Sites and associated dashboards for the Global Medical Writing alignment and communication.
• Maintains Global Medical Writing OKRs (Objectives and Key Results), keeping the team on track and communicating change, risk and impact.
• May mentor and/or supervise junior staff.
• Other duties as assigned.

Experience

Required Skills:

• 3-6 years of work experience in drug development (pharma/biotech or contract research organization), with a minimum of 1-3 years of direct project management experience in early and/or late stage clinical development
• Ability to drive, motivate and enable effective team meetings and high performing teams, while developing and maintaining professional interpersonal relationships with colleagues
• Strong documentation, organization and time management skills in a fast-paced environment
• Experienced with Project Professional software
• Minimum: Bachelor’s (BS/BA) in Biological Sciences or closely related field

Desired Skills

• Experience in the overall drug development process
• 1-2 years of nonclinical project management experience for IND-enabling (2+ drug class types)
• Strong familiarity with Regulatory submission requirements (IND through BLA/NDA)
• Experience with nonclinical study management/monitoring
• Experience with Microsoft Excel, SharePoint, PowerBI (PBI) and Microsoft Teams
• PMP certification preferred (or equivalent)

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.