job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With therapeutic areas that include Oncology, Vaccines, and Rare Diseases, our partner aims to make treatments streamlined, easily accessible, and globally produced. If you share their goal of approaching healthcare in a novel way, look no further - apply for your dream job now!
location: Cambridge, Massachusetts
job type: Contract
salary: $55.37 - 65.14 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Global Clinical Submissions Quality Lead to support Business Development Due Diligence activities: quality lead will review external clinical data and ensure that clinical data included on due diligence packages are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives.
- Expertise in clinical development and regulatory knowledge on requirements of drugs entering the market is key.
- The Quality Lead will ensure that clinical data included in the due diligence packages are complete and accurate and meet global regulatory requirements and internal quality standards, procedures and business objectives.
- Global Clinical Submissions Quality Lead will work predominantly with the Business Development Due Diligence team and GCSQ team to achieve quality goals.
qualifications: Education & Qualifications
- MS, PhD, PharmD, with at least 10 years expertise in drug development, including leadership roles, and subsequent regulatory submissions and hands on knowledge of the drug development and approval processes or equivalent combination of education and experience.
- Experience in clinical development programs and global drug submissions, e.g., New Drug Application (NDA) or Biologic Licensing Application (BLA) and supplemental applications Experience in one or more of the following: clinical development (Phases 1-3), statistics, project management, regulatory, and/or Quality.
- Experience in pharmaceutical drug development (Proof of Concept through Phase 3) or consumer healthcare products.
- Experience with New Chemical Entity (NCE) and New Biologic Entity (NBE) products or Consumer Healthcare/OTC products.
- Experience supporting products in the marketplace (e.g., Advisory Committee meetings, Post-Marketing Commitments, Product Labeling).
- Outstanding written and oral communication skills and demonstrated ability to communicate well across business lines.
- Makes timely and effective decisions by applying business acumen and seeks help quickly for prompt resolution of challenges
- Acts with urgency and removes barriers that hinder productivity
- Takes personal accountability for outcomes
- Understands others' unspoken, as well as explicit, concerns
- Adapts own behavior and approach to be more effective, inclusive, and to have positive impact on others
skills: Project Management, Quality control, Clinical Data Management, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.