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Associate Director, Global Regulatory Affairs Operations, Authoring Support
1 month ago
Job 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 Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group. You will oversee the implementation of submission templates, establish governance board responsible for global authoring templates and global dossier submission standards.
Develop an Authoring support team that is dedicated to working with cross-functional team members.
Develop and rollout training for authoring templates to cross-functional teams
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 resolutions
Responsible for creating and providing training to authors utilizing the submission templates.
Participate as an active team member and provide expertise to project teams as required
Minimum of a Bachelor’s degree from an accredited college of university
Ten years’ experience in pharmaceutical regulatory
Microsoft Word, ISI Toolbox, Veeva RIM)
Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
Knowledge of pharmaceutical industry regulatory development activities.
Experience with document management system, authoring templates (Acumen) and publishing process
Knowledge of domestic and international laws, regulations, and guidance that affect pharmaceutical products
Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product regulatory activities.
Ability to influence and partner with cross-site teams in a global pharmaceutical organization.
Scientists, Trial Managers, Scientific Writing, MW Writing,) to support product development strategy
Self-starter with superior time management skills, and ability to work independently or in teams.
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
Demonstrated ability to contribute to a continuous learning and process improvement environment
Focused ability to influence operational excellence and performance metrics
You are a fierce believer in our rooted-in-science approach to problem-solving
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.
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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
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.
