Scientist II

Job Description

Job Summary:

• We are seeking a motivated and detail-oriented Scientist II (Senior Scientist equivalent) for a one-year temporary assignment within our R&D Assay Development On-Market Support team.
• This role is dedicated to supporting global regulatory submissions for our on-market products.
• The successful candidate will be responsible for project management, regulatory response coordination, and documentation strategy, contributing directly to the continued success of our product portfolio.

Duties and Responsibilities:

1. Regulatory Submission Support:

• Coordinate and deliver timely, informed responses to global regulatory authorities’ questions related to assay development and product performance.
• Collaborate cross-functionally with Regulatory Affairs, Quality, and R&D teams to gather and synthesize necessary information for submissions.

2. Project Management:

• Track and manage activities and deadlines related to regulatory submissions and post-market support projects.
• Maintain project timelines and communicate status updates to stakeholders.

3. Product Knowledge Repository:

• Establish and maintain a comprehensive repository of product knowledge, including technical documentation, study data, protocols, and regulatory correspondence.
• Ensure the repository is organized, accessible, and up-to-date for internal use.

4. Documentation Strategy:

• Assess current documentation and design history files for completeness and regulatory readiness.
• Make recommendations and develop strategic plans to address gaps, including proposing new study plans, protocols, and documentation updates.
• Partner with subject matter experts to drive documentation improvements and ensure compliance with global regulatory requirements.

Education and Experience:

• PhD or MS in life sciences, chemistry, biochemistry, or related field (or equivalent experience).
• 3+ years of experience in assay development, R&D, or related scientific role; experience in regulated environments preferred.
• Demonstrated experience supporting global regulatory submissions or working with regulatory authorities.
• Experience with documentation systems, design history files, and regulatory documentation standards.
• Proficiency in Microsoft Office and project management tools.
• Previous experience in on-market support for medical devices, diagnostics, or related regulated products.
• Experience in establishing knowledge repositories or databases.
• Experience working in a GMP environment.

Knowledge, Skills and Abilities:

• Strong organizational and project management skills, with the ability to manage multiple deadlines and priorities.
• Excellent written and verbal communication skills.
• Ability to synthesize complex scientific information for a variety of audiences.
• Familiarity with global regulatory requirements (e.g., FDA, CE, PMDA).
• Solid knowledge of molecular biology, chemistry, biochemistry or related disciplines.
• Understanding of molecular diagnostic technology and nucleic acid amplification.
• Understanding of scientific method experimental design and statistical analysis.
• Ability to design both standard and factorial experiments for process improvement.
• Ability to analyze data and come to valid scientific conclusions.
• Ability to prepare and present studies to small groups of people.
• Sound technical writing skills and ability to document technical work.
• Ability to communicate effectively with peers and management.