Contractor - Manager, Regulatory Operations, Authoring Support Job in New Jersey (NJ), Regulatory Affairs Career, Jobs in Genmab
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Life Science Career Fair

Contractor - Manager, Regulatory Operations, Authoring Support job in Princeton

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Genmab jobs
New Jersey (NJ), Princeton
Job Code:  R10353
Employer:  Genmab
Category:  Regulatory Affairs

Location
Country:  United States
State:  New Jersey (NJ)
City:  Princeton
03/27/2024

Description
At Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.

The Role

The Authoring Support contractor will be part of the Global Regulatory Operations group and will be responsible for authoring support including word formatting and PDF document requirements to ensure timely and high-quality document delivery to the Regulatory Publishing Group. The contractor will work on the new template tool being deployed.

Responsibilities
  • Formatting of word documents in Genmab templates to ensure they are compliant to Genmab Authoring style guide and Health Authority requirements.
  • Facilitate the use of MS Word to create documents, work within template, with the ability to recognize and change errors in format.
  • Use ISI Toolbox for all PDF documents to ensure they are submission ready for eCTD submissions.
  • Assist with the migration of documents in old template to new Genmab templates.
  • Provide rollout training for authoring templates to cross-functional teams
  • Assists RA in interpreting FDA and ICH guidance as it relates to the established eCTD templates, in addition to numerous other submission types (e.g. BLA, IND, DSUR, or PAER).
  • Facilitate the use of MS Word to create documents, work within template, with the ability to recognize and change errors in format.
  • Working knowledge of electronic publishing/document management system.
  • Document all template related issues, and identify resolution

Requirements
  • Ten years' experience in pharmaceutical regulatory
  • Technical system skills (e.g. Microsoft Word, ISI Toolbox, Veeva RIM)
  • Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
  • A team player with demonstrated ability to collaborate with a diverse group of internal and external stakeholders (e.g. Scientists, Trial Managers, Scientific Writing, MW Writing,) to support product development strategy
  • Ability to balance multiple tasks to meet priorities and timelines.
  • Self-starter with superior time management skills, and ability to work independently or in teams.
  • Strong attention to detail.
  • Excellent communication skills; both oral and written.
  • Demonstrated ability to contribute to a continuous learning and process improvement environment
  • Focused ability to influence operational excellence and performance metrics

About You
  • You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
  • You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
  • You are a generous collaborator who can work in teams with diverse backgrounds
  • You are determined to do and be your best and take pride in enabling the best work of others on the team
  • You are not afraid to 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 leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you're in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Founded in 1999 in Copenhagen, Denmark, Genmab is an innovative biotech company that has become a leader in antibody biology and innovation. Our product pipeline and next-generation antibody technologies are the result of our strong company culture, a deep passion for innovation, and desire to transform cancer treatment and serious diseases.

When you work with us, you'll be part of a warm, fun, dynamic community, and team up with some of the best, most authentic individuals in locations around the world, who care deeply and share in a relentless drive to innovate and create transformational medicines. People who are candid, impact-driven, and a little unconventional; who seek out and embrace the opportunity to build new and bold futures within a rapidly growing and innovative biotech company; who bring their full selves to work and show up for each other - rolling up their sleeves to get the job done. This translates into a place where you can be authentically you; are empowered to innovate, build solutions, and execute; feel cared for and supported in growth; and are a critical part of changing the lives of patients around the world through transformative cancer treatment.

Our commitment to diversity, equity, and inclusion

We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on our website .

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 https://www.genmab.com/privacy .
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