Principal, Environmental Risk Assessment
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We take unique approaches to exploring and developing new preventive and therapeutic platforms to treat unmet medical needs, including recombinant vector vaccines, CAR-T cells and cell therapy applications.
An Environmental Risk Assessment (ERA) is part of the marketing authorisation applications for medicinal products to ensure a high level of safety for the general population and the environment. In addition, clinical trials with investigational medicinal products consisting or containing genetically modified organisms (GMO)s frequently require GMO (ERA) dossiers.
The Environmental Product Compliance & Sustainability (EPC&S) group has the responsibility for the ERAs to assure compliance and market access for the Janssen medicinal product portfolio. With the growth of the Janssen portfolio of medicinal products in development, EPC&S has a vacancy for a Principal, Environmental Risk Assessment.
The Principal will join the ERA team within EPC&S and will report to the Scientific Director, Global Environmental Risk Assessment. (S)he will take up the role as Subject Matter Expert (SME) for ERAs of biologicals and chemicals for the global Janssen product portfolio from early development to post-licensing.
The position will work closely with various stakeholders within Janssen such as global and regional regulatory affairs, CMC, non-clinical safety, project management, occupational biosafety and toxicology professionals. Externally, this position collaborates closely with consultants and contract research organizations for ERA dossiers and environmental fate and effect studies as well with expert groups and trade organizations.
- Create awareness and work closely with key stakeholders to identify new medicinal products that require an ERA
- Responsible for the delivery of the ERA dossier (biologics and chemicals) as part of a marketing authorization application or for clinical trials to be submitted to the relevant authorities.
- Responsible for ERA dossier life cycle submissions (e.g. responses to questions upon application, amendments, re-submission of ERA dossiers).
- Provide support throughout the lifecycle of the product to ensure consistency of environmental (bio)safety elements.
- Coordinate the scientific writing of the ERAs, working with expert co-authors, compiling all the relevant information for the ERA and lead review rounds, assuring compliance.
- For the products containing GMOs, lead the Janssen GMO submission working group for clinical trial and marketing authorizations.
- In support of ERAs for chemicals (API’s), define the testing strategy for the required environmental fate and effect studies; determine budget; select and monitor the Contract Research Organization (CRO) qualified for performing these studies.
- Support projects specific to ERA legislation to ensure the implementation of advocacy and policy program.
- Monitor the relevant legislation and inform internal stakeholders of significant changes.
Compliance & Governance
- Make sure the necessary data are derived/collected.
- Support the institutionalization of “ERA thinking” and data collection in the development and clinical trial processes.
- Monitor and communicate the performance of the ERA program to key stakeholders.
- Evaluate and implement relevant ERA program requirements for products under licensing and acquisitions
- Build the relevant network (internal and external) and invest in required competences anticipating to future ERA needs.
Bachelor’s/Master’s degree in Applied Biological Engineering, Biological & Biomedical Sciences, Biochemistry, Immunology and/or Microbiology, Toxicology or equivalent is required.
- 5+ years of experience in product stewardship and/or environmental risk assessment is required.
- Experience as EH& S / Biosafety professional is preferred.
- Experience working with regulatory/environmental authorities, NGO’s and similar agencies is desired.
- Strong leader: resilient, tenacious and persistent.
- Proven change agent.
- Collaborative team player.
- Result oriented, has a track record of tangible improvements.
- Clear and persuasive communicator, able to influence at all levels in the organization.
- Decision making and problem-solving skills.
Knowledge, Skills and Abilities:
- Have profound knowledge on the Environmental Risk Assessment principles for medicinal products.
- Knowledge on environmental fate and effect studies is preferred.
- Ability to work in a cross-functional environment.
- Ability to quickly interpret complex regulatory issues and provide recommended course of action.
- Experience in leading change to individual and organizational behavior impacting results.
- Scientific writing and documentation skills.
- Project management experience.
- Interfacing – associates & inspectors, assisting in audits.
- Interact with colleagues through face to face or virtual meetings enabled using video conference requiring ability to effectively exchange ideas and information with colleagues using these systems.
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.Primary Location
Netherlands-South Holland-Leiden-Other Locations
Europe/Middle East/Africa-Switzerland-Basel-City-Basel, Europe/Middle East/Africa-Switzerland-Berne-Bern, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Switzerland-Schaffhausen-SchaffhausenOrganization
Janssen Vaccines & Prevention BV (8852)Job Function
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