Associate Director, Global Regulatory Affairs Operations, Authoring Support

5-9 years

$142,500.00---$237,500.00

Princeton Junction

10 July 10, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Information:

Employer: Genmab
Position: Team Lead, Authoring Support Group
Category: Global Regulatory Operations
Locations:
- Copenhagen, Denmark
- Utrecht, Netherlands
- Princeton, New Jersey, U.S.
- Tokyo, Japan
Salary Range (US-based candidates): $142,500.00 - $237,500.00

Company Overview:

Genmab is an international biotechnology company dedicated to improving the lives of patients through innovative and differentiated antibody therapeutics. Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab has a global presence with locations in Utrecht, the Netherlands; Princeton, New Jersey, U.S.; and Tokyo, Japan. Genmab's core purpose is driven by a passionate, innovative, and collaborative team that has developed next-generation antibody technology platforms and a proprietary pipeline, including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. With over 20 strategic partnerships, Genmab aims to transform the lives of people with cancer and other serious diseases by 2030.

Role Overview:

The Team Lead for the Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support team within Regulatory Affairs (RA). The role includes ensuring timely and high-quality document delivery to the Regulatory Publishing Group, implementing submission templates, and establishing governance for global authoring templates and dossier submission standards.

Key Responsibilities:

Document Formatting:
- Coordinate formatting efforts for biologics and drug submissions per FDA and global health authority requirements.
Template Management:
- Lead the Templates Board and Governance for submission documentation templates.
- Create and manage submission documentation templates as needed.
Team Development:
- Develop and manage an Authoring support team dedicated to working with cross-functional team members.
- Develop and deliver training for authoring templates to cross-functional teams.
Regulatory Guidance Interpretation:
- Assist RA in interpreting FDA and ICH guidance related to eCTD templates and other submission types (e.g., BLA, IND, DSUR, PAER).
Document Creation and Management:
- Facilitate the use of MS Word for document creation and formatting.
- Maintain knowledge of electronic publishing/document management systems.
- Document all template-related issues and identify resolutions.
- Provide training to authors on submission templates.
Team Collaboration:
- Participate as an active team member and provide expertise to project teams as required.

Requirements:

Education:
- Minimum of a Bachelor’s degree from an accredited college or university.
Experience:
- Ten years of experience in pharmaceutical regulatory.
- Hands-on experience in preparing regulatory submissions during development and for marketing authorizations.
Skills:
- Technical system skills (e.g., Microsoft Word, ISI Toolbox, Veeva RIM).
- Knowledge of pharmaceutical industry regulatory development activities.
- Experience with document management systems, authoring templates (Acumen), and the publishing process.
- Understanding of domestic and international laws, regulations, and guidance affecting pharmaceutical products.
- Ability to interpret Regulatory Authority policies and apply them appropriately in product regulatory activities.
- Collaborative skills to work with diverse internal and external stakeholders.
- Strong organizational, project management, and multitasking skills.
- Self-starter with excellent time management skills.
- Strong attention to detail and proactive, goal-oriented approach.
- Excellent communication skills, both oral and written.
- Ability to influence operational excellence and performance metrics.
- Ability to see business drivers outside of Regulatory Affairs.

About You:

Passionate about transforming patients' lives through innovative cancer treatment.
Committed to excellence and a science-based approach to problem-solving.
Collaborative team player who values diversity and inclusion.
Determined to achieve and enable the best work from others.
Innovative and unafraid of challenges.
Experience in a fast-growing, dynamic company, or a strong desire to work in one.
Hard-working with a sense of fun and enthusiasm.

Work Environment:

Genmab promotes an agile working environment for better work-life balance. Our offices are designed as open, community-based spaces to connect employees and facilitate innovation. Whether working in our state-of-the-art laboratories or remotely, we thrive on collaboration and connection.

Commitment to Diversity, Equity, and Inclusion:

Genmab is committed to fostering workplace diversity and ensuring equal employment opportunities without discrimination or harassment based on race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, or any other characteristic protected by law. Learn more about our commitments on our website.

Privacy Policy:

Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application.

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