Regulatory CMC Dossier Development Associate Director
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Dover, DE 19904
Janssen Research and Development, LLC, a member of Johnson and Johnson’s Family of Companies, is recruiting for a Regulatory CMC Dossier Development Associate Director. This position can be located in Spring House, PA, Malvern, PA, Raritan, NJ, or can be based remotely in the US.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Scientific Integrator (SI) is a key member of Dossier Development & Operations responsible for writing CMC sections of regulatory submissions and managing responses to related Health Authority (HA) questions. The SI uses their scientific knowledge and technical writing skills, in conjunction with strong project management skills, to drive the timely completion of high-quality submissions across the Large Molecule and Small Molecule portfolios in Janssen R&D. He/she works closely with functional representatives on CMC Teams to gather data and presents the appropriate information in a clear and concise manner that supports HA approval and advances the development and commercialization of medical products. The SI develops the submission timeline, creates and manages eCTD documents, sets the dossier strategy, authors scientific content, and orchestrates the review and internal approval of content. If you want to be part of a dynamic and supportive team, are passionate about the drug development process, experienced in regulatory writing, and proficient at project management, this role has a lot to offer you.
• Authors sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations. Ensures all Quality submissions are completed in a timely manner.
• Leads DDO sub-teams in the creation of complex marketing applications and coaches junior SI on these teams.
• Supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance.
• Represents the department on multi-functional project development teams to support regulatory filings.
• Assumes personal ownership and accountability for business results and solutions working with limited supervision from the manager.
• Drives continuous improvement through efforts related to dossier template enhancement, process improvement, and advancing the understanding of regulatory requirements and expectations within the organization.
• PhD with Post-doc experience with 6+ years relevant experience, or University degree with 8+ years relevant experience, or equivalent by experience is required.
• Experienced in regulatory submission authoring with a clear understanding of eCTD structure and technical writing standards and approaches is required.
• Familiarity with the CMC drug development processes and comfort with electronic document management systems and authoring tools is required.
• Experience working in a scientific function within a development organization (i.e. Analytical, API, DPD) is highly preferred.
• Confidence in managing complex cross-functional projects and project teams is preferred.
• Project team management is preferred.
• Excellent interpersonal skills to support strong team relationships are required.
• Ability to effectively collaborate and influence without authority is required.
• This role is based in Spring House, PA, Malvern, PA, Raritan, NJ, or based remotely in the US.
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-Pennsylvania-Spring House-
North America-United States-New Jersey-Raritan, North America-United States, North America-United States-Pennsylvania-Malvern
Janssen Research & Development, LLC (6084)