- Lead the Templates Board and Governance for the submission documentation templates and create templates as needed.
- 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
- 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 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 Requirements
- Minimum of a Bachelor's degree from an accredited college of university
- 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.
- 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.
- 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.
- Ability to be proactive, enthusiastic and goal oriented
- Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
- 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 For US based candidates, the proposed salary band for this position is as follows:
- 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
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Associate Director, Global Regulatory Affairs Operations, Authoring Support - Princeton, NJ, United States - Genmab
Description
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 Role 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.
Responsibilities * Coordinates formatting efforts for biologics and drug submissions according to FDA and other global health authorities.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 GenmabGenmab 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.
By 2030, Genmab's vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSOTM) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan. Our commitment to diversity, equity, and inclusionWe 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.
