This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr Associate Project Manager based in United States.
This is an opportunity to support the development of biosimilar programs from early technical work through regulatory approval.
You will coordinate analytical similarity sample management and help technical teams maintain efficient, accurate workflows.
The role sits at the intersection of project management, scientific data, laboratory operations, and regulatory documentation.
You will collaborate with scientific, data management, quality, and cross-functional stakeholders in a highly collaborative environment.
Your work will help ensure samples, data, and documentation move efficiently through critical development processes.
Strong organization, analytical thinking, and attention to data quality will be essential to success.
This remote role offers the opportunity to contribute to meaningful life-science programs while developing your project management expertise.
Accountabilities
- Provide project management support to technical teams developing biosimilar candidates through regulatory approval, coordinating priorities, timelines, workflows, and deliverables.
- Manage analytical similarity sample activities, including inventory planning, sample distribution logistics, incoming data coordination, and collaboration with scientific and data management teams.
- Create and maintain electronic laboratory notebooks (ELNs), generate sample and lot identifiers, retrieve information from quality systems, and support related work orders and updates.
- Query and organize information from LIMS, ELN, and other databases, compiling data for review, verification, and project reporting.
- Coordinate with cross-functional teams, including similarity, critical reagents, data management, and scientific groups, to ensure accurate and timely completion of project activities.
- Maintain controlled documentation and support document archival, data verification, and regulatory filing activities in accordance with established procedures.
- Review scientific and regulatory documentation to identify data elements requiring verification and ensure accuracy and completeness.
- Support document formatting and preparation in accordance with internal style guidelines, quality standards, and established processes.
- Identify opportunities to optimize routine workflows, improve data practices, and strengthen collaboration across technical teams.
- Master’s degree, or bachelor’s degree with at least 2 years of project management experience, or an associate degree with 6 years of project management experience, or a high school diploma/GED with 8 years of project management experience.
- Experience supporting pharmaceutical research and development, nonclinical drug development, or related programs within the biotechnology, pharmaceutical, or life sciences sector is strongly preferred.
- Strong project coordination and organizational skills, with the ability to manage multiple priorities and workflows in a dynamic, fast-paced environment.
- Experience working with document management systems, collaboration platforms, laboratory information systems, or project management tools.
- Familiarity with scientific or regulatory document workflows and the ability to coordinate documentation throughout its lifecycle.
- Strong analytical skills and a solid understanding of good data practices, data verification, and data integrity principles.
- Proficiency with Microsoft Word and Microsoft Excel, with the ability to organize, analyze, and communicate complex information accurately.
- Strong written and verbal communication skills, with the ability to collaborate effectively across scientific, technical, data management, and business teams.
- A bachelor’s or advanced degree in life sciences, regulatory affairs, business, or a related discipline is preferred.
- Competitive annual base salary range of $89,168.40-$120,639.60, depending on relevant skills, experience, and qualifications.
- Comprehensive health and welfare benefits for eligible employees and dependents.
- Medical, dental, and vision coverage.
- Retirement and savings plan with company contributions.
- Life and disability insurance.
- Flexible spending account options.
- Potential discretionary annual bonus based on eligibility.
- Potential stock-based long-term incentives.
- Award-winning paid time-off programs.
- Bi-annual company-wide shutdowns.
- Flexible work models, including remote and hybrid arrangements where applicable.
- Opportunities for professional development and career growth.

