Johnson & Johnson Careers
Lead Associate, Submissions Management
Requisition ID: 0179190322
Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting for a Lead Associate, Submissions Management with experience in planning and publishing major global marketing application submissions and related lifecycle management to be part of the Regulatory Submissions Management and Operations team within Global Regulatory Affairs (GRA). This position may be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA.
- Create and manage Dossier Plans/Submission Packages in line with regulatory strategy, seeking input from regulatory therapeutic areas, functional area representatives, and key stakeholders, while providing guidance to project team members.
- Utilize regulatory information management systems and tools to assemble, publish, validate, dispatch and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence.
- Apply appropriate regulatory submission standards, requirements, processes, and policies to ensure compliance with applicable internal and external health agency guidelines.
- Cultivate ongoing effective relationships across GRA as well as cross-functionally. Maintains open communications with key partners to communicate and resolve issues/concerns with submission timelines.
- Manage multiple high complexity submissions simultaneously with a high-degree of independence.
- Perform a dossier review of the published output.
- Lead Submission Team meetings to coordinates the preparation and maintenance of regulatory submissions and filings.
- Monitor the effectiveness of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
- Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
- May lead and/or participate in special projects and process improvements, and associated training material.
- A minimum of Bachelor’s degree (or equivalent) in a scientific discipline is required
- An advanced degree (MS, PhD, MD or PharmD) is highly desired
- A minimum of 6 years of relevant experience with a Bachelor’s degree is required OR Masters/PharmD with 4 years of relevant experience OR PhD 2 years of relevant experience is required
- Experience associated with publishing submissions for global Marketing Applications (e.g., NDA/BLA/MAA/NDS) and related lifecycle is required
- Experience associated with planning of lifecycle Market and Registration submissions (e.g., NDA/BLA/MAA/NDS) is required
- Experience publishing/planning Marketing Applications for emerging markets (ie: AsiaPac LATAM, Middle East/Africa, etc.) is highly preferred
- Experience of coordinating and compiling submissions using publishing technologies, submission portals, and document management systems
- In-depth understanding of drug development process is required
- Demonstrated project or submission management capabilities is highly preferred
- Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings is highly preferred
- Ability to work in a matrix environment required
- Demonstrated ability to build productive relationships and influence stakeholders across an organization required
- Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required
- Ability to use Regulatory Information systems required
- This role will be located in Raritan, NJ; Titusville, NJ; Spring House, PA; Horsham, PA; Radnor, PA; Malvern, PA, La Jolla, CA; San Francisco, CA; Los Angeles, CA
- This position may require up to 5% domestic and international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-New Jersey-Raritan-
North America-United States-California-Los Angeles, North America-United States-California-San Francisco, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Horsham, North America-United States-Pennsylvania-Malvern, North America-United States-Pennsylvania-Radnor, North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla
Janssen Research & Development, LLC. (6084)