HireDiversity

Spring House, PA, US

Scientist — Regulatory CMC Dossier-6717130109

Description

Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is recruiting for a Scientist - Regulatory CMC Dossier, to be located in Springhouse, PA, Malvern, PA Titusville, NJ or Raritan, NJ.

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.

The Scientist - Regulatory CMC Dossier manages the development of Quality related CTD sections (Module 3) with supervision from senior staff. Coordinates and provides technical oversight for the generation of the CMC dossier (module 3) of marketing and clinical trial submissions with close supervision of senior staff. Coordinates the timeline, virtual document and the generation of the Quality module. Assumes personal ownership and accountability for business results and solutions working with supervision from senior staff. Represents the department on multi-functional project development teams to support regulatory filings.

The Scientist - Regulatory CMC Dossier supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications. Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions. Ensures all Quality submissions are completed in a timely manner.

The Scientist - Regulatory CMC Dossier continues to develop a knowledge of regulatory guidances. Provides interpretation with some guidance from senior staff of relevant CMC guidances (ICH, FDA, EMA, etc) and provides prompt regulatory risk assessments and recommendations.

Qualifications


A minimum of a Bachelor's degree in Chemistry, Biology or a related science with a minimum of 5 years relevant experience required. Experience in the Pharmaceutical, Biotech and/ or other FDA regulated environment is required. A Master's or PhD in Chemistry, Biology or a related science is preferred. A minimum of 2 years of experience in leading global CMC dossier preparation and filings is preferred. Large molecule experience a plus. Technical background in chemistry or pharmaceutics is required.

The successful candidate must be able to navigate ambiguous situations and provide consistent support for the CMC technical functions contributing to the Quality submissions. Ability to consistently develop clear and unambiguous direction and structure for the CMC team, with the demonstrated ability to seize opportunities in projects and within CMC organization to influence direction and decisions required. Excellent verbal and written English language skills required. Ability to actively listen and engage in constructive communication with exceptional interpersonal skills in order to help manage technical reports authored by the functions for submission in regulatory applications is essential.

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.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-Pennsylvania-Spring House
Organization: Janssen Research & Development, LLC. (6084)