Janssen Research & Development, LLC., a Johnson and Johnson Company is hiring an Associate Director, to be located in Spring House or Malvern, PA or Titusville or Raritan, NJ.
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 Associate Director, Dossier Development, PDMS, is responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. The ideal candidate will provide input and technical oversight of the generation of the CMC dossier of marketing and clinical trial submissions. They will coordinate the timeline, virtual document and the generation of the Quality module. The will assume personal ownership and accountability for business results and solutions working with limited supervision from the manager and represent the department on multi-functional project development teams to support regulatory filings. Responsibilities include but are not limited to the following:
- Authors/drives sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations
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 from the manager.
Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager.
Ensures all Quality submissions are completed in a timely manner.
Manages functional or project teams with up to 15 members; Acts as a mentor to one or more individuals
- Bachelor’s degree in Chemistry or related science with at least 10 years of relevant industry experience OR a Master’s degree with at least 8 years of relevant industry experience OR PhD with at least 6 years of relevant experience (industry, post-doctoral, graduate course work, etc.) is required
- Large Molecule and/or small molecule CMC regulatory writing experience is required
- At least 3 years of direct CMC regulatory marketing application writing experience in a Regulatory Affairs, Dossier Development or Technical Support Function group is required
- Technical background in chemistry, pharmaceutics or related science is required
- Must possess scientific understanding of pharmaceutical development functions as well as knowledge of the proper interpretation of applicable global regulatory guidances
- Proficiency in commonly used computer applications including WORD, EXCEL etc. required
- This position requires local travel and up to 10% international travel. This position may be located in Springhouse, PA, Malvern, PA, Raritan, NJ or Titusville, NJ. If the candidate is located in Raritan, NJ, Titusville, or Malvern, PA additional travel to Springhouse, as needed by business may be required
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Malvern, North America-United States-New Jersey-RaritanOrganization
Janssen Research & Development, LLC. (6084)Job Function