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Job Description

The** **Position

The Non-Clinical Safety Assessment Representative within the Non-Clinical Development (NCD) team, is accountable for the representation of the non-clinical safety function (i.e., toxicology) on asset development teams (ADTs). This position will report to the Non-Clinical Safety Assessment Lead. The NCD team is comprised of non-clinical drug development scientists representing toxicology, DMPK, pharmacology, and translational sciences which serves as a key function within the Translational Medicine and Early Development (TMED) team spanning discovery through early clinical development. The Non-Clinical Safety Assessment Representative is expected to participate in cross-functional development programs with early clinical development, late-clinical development, regulatory affairs, safety and pharmacovigilance, Chemistry, Manufacturing and Controls (CMC), medical affairs and business development.

Non-Clinical Safety Assessment Representative is responsible for strategic and technical contributions to development programs. This position will contribute to design, oversight and execution of the non-clinical toxicology strategy for pipeline R&D products. Additionally, this position may contribute to business development activities and existing products (eg, life-cycle management) in the Organon portfolio, as necessary. This position will also be responsible for reviewing and authoring non-clinical and clinical modules for regulatory submissions, briefing books and other regulatory documents, as applicable.

Responsibilities

+ Serves as the Non-Clinical Safety Assessment (toxicology) representative on interdisciplinary asset development teams (ADTs).

+ Plans and executes non-clinical safety studies and assessments at appropriate stages to support asset progression through development and to meet project timelines.

+ Serving as the subject matter expert in the non-clinical field in meetings with internal/external stakeholders

+ Author and review of non-clinical CTD modules for regulatory submission (e.g., IND, NDA), briefing books, or other regulatory communications for regional regulatory submissions or renewals for global products within the Organon portfolio.

+ Provide scientific and strategic non-clinical safety (toxicological) input into Organon’s pipeline programs, business development activities, and existing product portfolio as an ADT representative.

+ Serve as a subject matter expert and/or provide technical area expertise for non-clinical development issues.

+ In conjunction with Non-Clinical Operations, coordinate non-clinical pharmacology and toxicology studies at Contract Research Organizations (CROs).

+ Assist in the preparation and review of study protocols and research reports.

+ Authorship of non-clinical sections of IND, CTA, NDA, MAA, and relevant regulatory documents of assets in Organon portfolio.

+ Ensure that non-clinical studies are conducted in compliance with relevant regulations, guidelines, and animal welfare standards.

+ Author or review the non-clinical, early clinical development or CMC documentation to support regulatory submissions to regional Health Authorities worldwide; may participate in interactions with Health Authorities.

+ Contribute to regional or global product label reviews and updates, as appropriate.

+ Engage and communicate effectively with regulators, scientific leaders, and physicians, as needed.

+ Support the product portfolio in line with Good Laboratory Practices (GLP) and relevant Organon Standard Operating Procedures (SOPs).

Required Education, Experience and Skills

+ PhD, DVM or equivalent degree in pharmacology, biology, physiology, biochemistry, chemistry, toxicology or related sciences.

+ Board certification in toxicology a plus (e.g., DABT, ERT).

+ A minimum of five to seven years of experience in the pharmaceutical or biotech industry with extensive and in-depth knowledge of non-clinical safety assessment and drug development, including a strong background in toxicology with competency in DMPK and pharmacology.

+ Demonstrated knowledge of non-clinical development as well as drug substance and drug product impurity-related regulatory guidelines and GxP requirements.

+ Experience with review and authoring non-clinical sections of regulatory dossiers (e.g., NDAs) and product labels with first-hand experience with agency interactions (meetings, briefing books and response documents).

+ Experience in working in project teams (preferably global project teams).

+ Exhibits effective communication and collaboration, integrity, and respectful interactions with Organon personnel.

+ Excellent organizational and interpersonal skills.

+ Ability to manage multiple projects and shifting priorities.

+ Ability to process and articulate complex ideas in a manner that can be clearly communicated to less technically trained individuals.

+ Ability to analyze and report results from literature reviews and preclinical and clinical studies

+ Ability to prioritize and focus on important data and considerations to drive results and provide solution-oriented recommendations with an appropriate scientific rationale to address challenges.

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 is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)

$125,400.00 - $213,100.00

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:

Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

**Requisition ID:** R537011