Senior Medical Manager, Quality Control

Genmab; Plainsboro Township (NJ); On-site; USD 126,000 - 190,000; Full time

Job summary

Genmab seeks a Senior Medical Manager for Quality Control to ensure the integrity of clinical and regulatory documents. The ideal candidate will have over 7 years of relevant experience in the biotech/pharma field, highlighting strong document preparation skills and a collaborative spirit. This role also supports innovative solutions to meet patient needs and enhances the quality of regulatory submissions.

Benefits

401(k) Plan: 100% match on the first 6% of contributions

Health Benefits: Including HDHP with HSA, dental, and vision insurance

Paid vacation, sick leave, and holidays

12 weeks of discretionary paid parental leave

Tuition reimbursement and commuter benefits

Qualifications

• 7+ years of experience in document quality control in the pharmaceutical/biotech industry.
• Strong experience in document content preparation.
• Experience in a multi-functional environment.

Responsibilities

• Edit and finalize complex clinical and regulatory documents.
• Provide guidance on document strategy and timelines.
• Contribute to template development and medical writing standards.

Skills

Document Quality Control

Collaboration

Regulatory Guidance

Education

Bachelor's degree in science

Master's/Advanced degree preferred

Job description

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At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

This individual supports content QC of regulatory and clinical documents in the Medical Writing group.

Responsibilities

Independently edit, and finalize complex clinical and regulatory documents including clinical trial protocols/amendments, investigator’s brochures, and clinical study reports

Independently edit Health Authority briefing packages, Health Authority responses, and clinical CTD submission documents

Provide guidance on document strategy and content, timelines, and resource needs to ensure timely completion of tasks with desired quality

Actively contribute to the development of templates and establishment of medical writing processes and standards

Recommend and lead process improvement initiatives and actively participate in inter-and intra-departmental knowledge sharing sessions

Requirements: Bachelor's degree in science or related area; Master's/ Advanced degree preferred

• At least 7 years (Senior Manager) of relevant document quality control experience in the pharmaceutical/biotech industry, specifically, experience performing quality control checks to ensure data integrity of clinical study reports, clinical trial protocols/amendments, investigator’s brochures, clinical summaries, health authority briefing books, and health authority response documents
  
  

Strong experience of document content preparation, including the use of style guides, medical dictionaries, and regulatory guidance documents and templates

Experience working in multi-functional environment

For US based candidates, the proposed salary band for this position is as follows:

$126,240.00---$189,360.00

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
  
  

About You

• You are genuinely passionate about our purpose
• You bring precision and excellence to all that you do
• You believe in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
• You take pride in enabling the best work of others on the team
• You can grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so!
  
  

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website Job Applicant Privacy Notice (genmab.com).

Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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