The RoleGenmab is searching for an energized Senior Associate to be part of Global Clinical Supply Systems in Plainsboro, NJ within commute distance to our office location to work according to an in-office or hybrid work arrangement.
With an impressive pipeline and many ongoing clinical trials, you will have a central role in supporting inspection readiness across our late-stage clinical development portfolio. Your work will help ensure that documentation is complete, compliant and readily available to support the successful execution of business-critical GMP and GCP inspections.
You will support inspection readiness activities within Global Clinical Supply Systems, collecting, organizing and performing completeness and compliance checks of trial-specific documentation. During inspections, you will participate in back-office activities and help ensure timely retrieval and follow-up of requested information.
The role also offers an opportunity to develop beyond inspection readiness. You will work closely with the Head of Global Clinical Supply Systems along with other team members to support selected functional initiatives, providing exposure to broader activities across the organization and vendor network. In parallel, you will have the opportunity to build your GMP, GCP, and clinical supply knowledge by learning and supporting selected operational activities.
The position reports to the Director, Head of Global Clinical Supply Systems or Associate Director, IRT Management based in Plainsboro, NJ.
Responsibilities - Support inspection readiness across late-stage clinical trials by collecting, organizing and maintaining relevant clinical supply documentation.
- Perform completeness and compliance checks of trial-specific documentation against applicable procedures and inspection-readiness expectations.
- Participate in back-office activities during GMP and GCP inspections, including document retrieval, request coordination and tracking of responses and follow-up items.
- Support preparation for mock inspections, audits and health authority inspections, including compilation and review of supporting documentation for completeness and readiness.
- Support the Head of Global Clinical Supply Systems with selected functional initiatives and tasks across the organization.
- Support activities related to our IRT/RTSM vendor network, including coordination, follow-up and preparation of relevant material and documentation.
- Build knowledge of GMP, GCP, and clinical supply activities within Global Clinical Supply.
- Participate in maintenance and continuous improvement of procedures, tools and ways of working supporting inspection readiness and clinical supply activities.
- Responsible to be compliant with Genmab's quality system.
Requirements - Minimum a bachelor's degree or equivalent.
- Some experience working with documentation, quality or compliance activities in the pharmaceutical, biotech, clinical research or another regulated environment is an advantage.
- Knowledge and understanding of GMP and GCP; experience with inspection or audit readiness is an advantage.
- Strong interest in documentation, quality and compliance, with a structured and detail-oriented approach to your work.
- Ability to coordinate activities, maintain structure and follow up on actions involving multiple stakeholders.
- Ability to work successfully under pressure in a fast-paced environment and with tight timelines, including during inspections.
- Ability to be proactive, enthusiastic, curious and goal orientated, with a willingness to learn new GMP-related activities.
- A team player with demonstrated ability to work effectively with internal and external stakeholders, including CMOs and vendors.
- Strong communication skills in English - both oral and written.
The TeamYou will be part of a highly competent team focused on GMP, GCP, and computerized system management with a strong focus on quality, inspection readiness and successful collaboration with our internal stakeholders and vendors.
Together with Global Clinical Supply Portfolio & Project Delivery and Global Clinical Supply Manufacturing, the teams make up the Global Clinical Supply department.
We have an international and informal working environment with a high pace, strong one-team spirit and close collaboration across functions.
ApplicationHas this sparked your interest? Then we encourage you to upload your CV and cover letter including your motivation for this position. We screen candidates on a continuous basis and call in for interviews.
Fully remote applicants will not be considered, so please indicate if you are willing to relocate if you're not currently living in commute distance.
For US based candidates, the proposed salary band for this position is as follows:
$82,480.00---$123,720.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
When you join Genmab, you're joining a culture that supports your physical, financial, social, and emotional wellness. Within the first year, regular full-time U.S. employees are eligible for:
- 401(k) Plan: 100% match on the first 6% of contributions
- Health Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance
- Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
- Time Off: Paid vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave
- Support Resources: Access to child and adult backup care, family support programs, financial wellness tools, and emotional well-being support
- Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
Further details on eligibility for compensation and benefits based on role will be provided during the recruitment process
