Associate Director, Occupational and Environmental Toxicology

1 week geleden

Amsterdam, Nederland Organon Voltijd

**The Position**

The Organon Global Safety, Health and Environment (SHE) organization is seeking an Associate Director, Environmental, Health and Safety (EHS), Occupational and Environmental Toxicology to join our product stewardship team. The person in this role is a key part of our product stewardship program and will work in close collaboration with SHE colleagues and members of numerous cross-functional organizations to ensure we are meeting our product stewardship obligations, protecting human health and the environment and delivering sustainable business value. The individual in this role will play an important part in the continuing evolution of our product stewardship program and its associated ways of working, business processes and systems. This is a great opportunity to be part of a mission-focused pharmaceutical and medical device company passionate about making the lives of women better every day.

**Responsibilities**

Occupational Toxicology
- Responsible for leading the Organon Drug Handling Committee and the development and life cycle management of ADEs, OELs, and similar exposure-related thresholds, including risk communication to all relevant stakeholders internally and externally for our molecules, potent compounds, marketed drugs, etc.
- Providing robust, scientifically-sound risk management processes to support health hazard assessment for employees handling of compounds.
- Updating and revising procedures and guidelines related to health hazard assessments.
- Revising and/or developing hazard banding or default methodologies for early-stage project in lieu of established health-based exposure limits.
- Leveraging expert technical advice in preparation of toxicology assessments in support of health hazard classification:

- Safety Data Sheets according to country specific GHS regulations (e.g., CLP, UK-CLP, OSHA, and others), and assisting in the review of the Dangerous Goods classification.
- Supporting company regulatory registrations and notifications (e.g., REACH compliance), including support for market authorization submissions for relevant occupational and environmental risk assessment and safety information.
- Providing technical support to Occupational Medical/Health Services for possible occupational exposures and related health risk assessments.
- Collaborating with industrial hygiene network, operations, and R&D teams as part of a comprehensive occupational hazard evaluation, controls, and risk assessment.
- Supporting business development activities focusing on occupational and environmental toxicology related aspects and associated knowledge transfer.
- Assuring appropriate reporting of safety data to support health-protective limits.
- Collaborating with colleagues in cross-functional organizations (e.g., Quality, Manufacturing, R&D) to ensure that proposed limits and exposure controls are health protective and implementable.
- Evaluating appropriate data and effectively communicate and mitigate risk.
- Preparing and reviewing reports, memos, SOPs and regulatory documents.
- Establishing and maintaining collaborative partnerships with leaders to ensure alignment of program and emerging risks.

Environmental Toxicology
- Leading the environmental toxicology program.
- Establishing science-based Environmental Quality Criteria (Predicted No Effect Concentration) for active pharmaceuticals ingredients, intermediates and other compounds.
- Supporting regulatory filings for environmentally-related aspects, including Environmental Risk Assessments.
- Supporting projects related to contaminants of concern in the environment (e.g., PFAS) providing toxicology expertise as part of the risk management and mitigation activities.

Program Management
- Leading the Occupational and Environmental Toxicology program responsible for business processes, systems, document lifecycle review and management, program SharePoint site and business resilience. Continuing to evolve the program to deliver the desired outcomes, effectively, efficiently and in alignment with the Organon business strategy.
- Participating in regulatory surveillance, strategically planning for emerging regulations, assisting with implementation of compliance strategies and supporting interactions with industry trade groups, professional associations and other advocacy activities.
- Supporting the broader Safety, Health and Environment Product Stewardship program.

**Required Education, Experience and Skills**
- Ability to analyze and identify data/process gaps and propose weight of evidence-based solutions and approaches.
- Experience working within the pharmaceutical / biotechnology and medical device industry, including knowledge of manufacturing processes.
- Ability to work effectively with all levels of personnel across a global, matrixed organization.
- Excellent written and verbal communication, with strong presentation, facilitation and engagement skills.
- Expertise within practices, procedures, and EHS concepts,

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