Organon & Co
Director, Occupational and Environmental Toxicology
Organon & Co, Plymouth Meeting, Pennsylvania, United States, 19462
Job Description
The Position
The Organon Global Safety, Health and Environment (SHE) organization is seeking a Director SHE, 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.
As Director SHE, Occupational and Environmental Toxicology, you will be:
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
* High level of aptitude in applying sound scientific principles to synthesize scientific and regulatory literature for a broad audience.
* 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.
* A proven ability to influence business process decisions across a variety of topics and audiences with differential subject matter expertise.
* Excellent written and verbal communication, with strong presentation, facilitation and engagement skills.
* Expertise within practices, procedures, and SHE concepts, such as health and safety programs, hazard communication and laboratory safety.
* A drive to manage global programs and proactively adapt to changes as Organon continues to evolve as a global pharmaceutical and medical device company.
* Advanced degree in Toxicology or related field with 10+ years of relevant experience in Occupational and Environmental Toxicology or equivalent life science subject areas is required.
Secondary Language(s) Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$136,600.00 - $232,300.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%
Flexible Work Arrangements:
Flex Time, Telecommuting
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
The Position
The Organon Global Safety, Health and Environment (SHE) organization is seeking a Director SHE, 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.
As Director SHE, Occupational and Environmental Toxicology, you will be:
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
* High level of aptitude in applying sound scientific principles to synthesize scientific and regulatory literature for a broad audience.
* 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.
* A proven ability to influence business process decisions across a variety of topics and audiences with differential subject matter expertise.
* Excellent written and verbal communication, with strong presentation, facilitation and engagement skills.
* Expertise within practices, procedures, and SHE concepts, such as health and safety programs, hazard communication and laboratory safety.
* A drive to manage global programs and proactively adapt to changes as Organon continues to evolve as a global pharmaceutical and medical device company.
* Advanced degree in Toxicology or related field with 10+ years of relevant experience in Occupational and Environmental Toxicology or equivalent life science subject areas is required.
Secondary Language(s) Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
US and PR Residents Only
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.
Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
Annualized Salary Range (US)
$136,600.00 - $232,300.00
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%
Flexible Work Arrangements:
Flex Time, Telecommuting
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1