Director, Medical Affairs Position Summary: • This role will provide management of project related activities for Medical Affairs. They will report directly to the head of Medical Affairs. This individual must be exceptionally organized, diligent, detail-oriented, flexible, team oriented, dynamic and adaptable to a fast-paced start-up environment and have experience in supporting multiple...

Recruiter- IT/Engineering Hybrid Schedule Windham NH 03087 Do you have a passion for connecting people with great opportunities? We're looking for a driven and energetic Entry-Level Recruiter to join our growing team! In this role, you'll play a key part in our success by sourcing, attracting, and placing top talent for our client companies in the Life Sciences and Healthcare verticals....

Med Device Systems Engineer Seeking a full-time Systems Engineer to join our team in Marlborough, MA. In this role, you will design and develop cutting-edge hardware and software solutions for complex medical devices, making a real impact on patient care. You’ll collaborate with cross-functional teams to transform innovative ideas and user needs into life-saving technologies. This position will...

Head of Quality Assurance and Compliance Position Summary: The Head of Quality Assurance and Compliance (QAC) is primarily responsible for the management and oversight of all aspects of QAC. Responsibilities include partnering with internal and external cross-functional stakeholders on quality related activities. This position provides quality, regulatory and technical expertise to manage...

Location: Princeton, NJ (Hybrid, 3 days on-site 2 days remote) Contract Length: 6-12+ Months   Position Summary: This position will be responsible for all QA oversight of GCP activities. The primary responsibilities will be to ensure quality and compliance of: • Sponsored clinical trials with respect to Standard Operating Procedures, applicable regulatory requirements (FDA, EU, ICH & country...

We are seeking a Clinical Trial Assistant to be a key member of the Clinical Operations team, responsible for providing administrative and project support for the Clinical Department. Primary Responsibilities: • Assist with the auditing and reconciliation of all study-related documents for clinical trials • Maintain version and quality control of study documentation and submit to Trial...

Job Title: Medical Writer PRINCIPLE DUTIES: • Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents  • As needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents  ...

Precision Life Sciences is seeking a Biostatistician that will represent Biostatistics on study teams, report study status to Biostatistics management, and perform, or oversee the performance of, all Biostatistics-related activities while ensuring the integrity of the data and analysis by adhering to all applicable regulatory requirements and Standard Operating Procedures (SOPs).  ESSENTIAL...

Reporting to the SVP of Marketing and Business Analytics, this individual will collaborate with internal and external partners to assess organizational needs and lead the management of our Sales Operations and Market Insights functions. This role requires strong leadership and understanding of the oncology marketplace, data analytics and reporting, market research, and project management. The...

Summary: The Senior Director Pharmacovigilance (PV) Operations will be accountable for the overall PV operations, which includes all aspects of adverse event collection, processing and reporting from all sources, vendor management, and associated PV quality management, for entire portfolio in clinical development and post approval. The Senior Director PV operations leads the PV operations team...

As an Associate Director, Outsourcing and Vendor Governance team member, you will be responsible for managing and optimizing Vendor Engagement. The individual will also support outsourcing needs for current and future clinical trials, including vendor identification, RFPs, vendor selection, contract and budget negotiations, budget management. You will work closely with the Clinical Operations and...

Compliance Engineer THE ROLE DESCRIPTION • Coordinate with Engineering to design and analyze test cases for our clients' products, prioritizing high quality standards and product consistency • Lead projects to adopt UL and CSA certification standards to ensure compliance within the North American market • Manage test plans for high voltage electric vehicle charging equipment to meet...

JOB SUMMARY: Seeking a highly skilled and experienced Oncology Medical Director to join our dynamic team. The successful candidate will have a strong background in oncology, extensive experience in Phase III clinical studies, and a proven track record in managing global clinical trials. This role is pivotal in driving the clinical development of our oncology pipeline and ensuring the successful...

JOB TITLE: Administrative Assistant (Bilingual - Korean/English) LOCATION: Boston MA (Onsite: 3 days per week) JOB SUMMARY: A detail-oriented and organized Administrative Assistant with proficiency in both Korean and English is needed. The ideal candidate will support day-to-day administrative tasks, ensuring smooth operations within the office. This role requires being onsite at least three...

The Executive Director of Data Management will be responsible for leading and managing the strategic and operational aspects of data management in the support of Clinical Development functional activities, including database build, database lifecycle management, data review, vendor management and oversight across all studies and programs. The Executive Director will manage the company program-wide...

PRINCIPAL DUTIES: • Responsible for individual/territory sales performance and goal attainment • Understand the Oncology/RCC environment; have in-depth knowledge of disease-state, local drivers, treatment and referral patterns, etc. • Develop strong relationships with key customers practicing in your geography • Prepare and implement a comprehensive business plan for territory • Exercise...

We are looking for an experienced and motivated Senior Scientist to join us as a member our Development team. In this role you be responsible for effective planning, execution and coordination of assay and reagent development efforts to ensure the successful delivery of products with the highest quality, safety, and effectiveness. Candidates for this position must enjoy working for a fast-paced,...

PRINCIPAL DUTIES: • Strategic Quality Leadership: • Develop and implement a robust Supplier Quality Management System that ensures all outsourced GMP operations are in compliance with all relevant regulations and industry standards. • Provide strategic direction and oversight of Quality Assurance activities across all stages of product development and commercialization. • Lead cross...

Senior Controls Engineer Position Summary This position involves designing controls systems for automation machines, ensuring they meet project requirements, customer expectations, and our client's standards. The candidate should communicate project requirements, develop controls architecture, verify electrical design packages, and create designs that adhere to safety and standards. They will...

The Director, Clinical Pharmacology and Pharmacometrics is responsible for providing strategies, plans and deliverables on pharmacology and related pharmacometrics & quantitative analytics, for the advancement of select programs across all stages of drug development. Primary responsibilities include the strategic planning and execution of translational & clinical pharmacology activities, as a core...

The Senior Quality Manager, Commercial Quality reports to the Director Quality Assurance and is responsible for Quality Operations. Primary responsibility includes quality oversight and compliance activities related to the cGMP manufacture and release of commercial products. The successful candidate will be responsible for interfacing with global contract development manufacturing organizations...

Automation Engineer - Delivery Lead Key Objectives/Deliverables • Work safely and continually look for improvements to both people and equipment safety. • Expertise with Automation Technologies – Lead the corporation’s efforts to better engineer automation projects on all platforms. • Automation/Control Discipline and Technical Leadership – Partner with colleagues to lead the discipline...

The Associate Director, Quantitative Pharmacology and Modeling & Simulation (M&S) is responsible for providing strategies, plans and deliverables on pharmacology and related quantitative analytics, for the advancement of programs across all stages of drug development. Primary responsibilities include the strategic planning and execution of pharmacology- and biomarker-related modeling & simulation...

Seeking an Industrial Client Service Leader to help further accelerate the growth of our Industrial business unit by identifying promising new opportunities, winning exciting new projects and growing key client accounts. This individual will bring experience selling small-mid capital sized engineering procurement construction (EPC)design-build delivery projects. This individual has helped clients...

We are looking for a Clinical Mapping Specialist to be a key member of our high functioning Data Science team, leading important clinical and preclinical data acquisition and interpretation activities. This person will gain system-level understanding of a novel and potentially game-changing technology in a fast-moving field and grow their career in design and R&D. Responsibilities •...

PRINCIPAL DUTIES: • Partner with Senior Controller to operate the day to day accounting, partnering with business units and cultivating relationships that drive the business forward. • the general accounting operations, ensuring compliance with GAAP, and the preparation of accurate and timely financial statements and management reports. • Oversee monthly, quarterly and annual closing...

Position Description We are looking for individuals who share the importance of science-based selling, supported by a strong foundation of business analytics. The OAM will also possess a deep knowledge of the oral drug space, as well as background in later line oncology and or hematology malignancy. A solid understanding of the oncology therapeutic area is essential, with a preference for...

The Senior Quality Manager, Clinical Quality reports to the Director Quality Assurance and is responsible for Quality Operations. Primary responsibility includes quality oversight and compliance activities related to the cGMP manufacture and release of clinical products. The successful candidate will be responsible for interfacing with global contract development manufacturing organizations...

Position Summary: We are seeking a highly skilled CQV (Commissioning, Qualification, and Validation) Engineer for a contract position with a strong focus on DeltaV Automation. The successful candidate will be responsible for the qualification and validation of automated systems in a regulated biopharmaceutical manufacturing environment. This role involves executing CQV protocols, ensuring...

The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for executing global CMC regulatory strategies for our programs in early and late-stage development through and beyond approval. This position supports  clinical registration, commercial development, and manufacturing efforts, as applicable. This position partners with the manufacturing team, clinical...

Senior Accounts Payable Associate Key Purpose: The Sr. Accounts Payable Associate is responsible for aspects of accounts payable including vendor relations and administrative support tasks. Primary Duties + Responsibility: • Review vendor invoices against purchase orders and research any discrepancies. • Route all invoices to appropriate internal parties for approval. • Ensure accurate...

The Clinical Contract Manager works closely with the CDO project teams, R&D Service Providers, clinical sites, and other R&D functional leaders across Clinical Operations, Legal, Finance, Corporate Compliance to ensure appropriate contracts are in place for each of the clinical trials and clinical operations projects and that service providers are engaged to support clinical operations. •...