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Job Description

The Position

The Associate Director, Biopharmaceutics will provide expert biopharmaceutical guidance on the pharmacokinetic performance of drug products during formulation development and the drug product life cycle, including interpretation of relevant dissolution data. The scope includes small molecules and biologics/biosimilars, simple and complex formulations within Organon’s general medicines portfolio as well as early development pipeline assets. The position serves an important role in the preparation of biowaiver requests for manufacturing site changes or active pharmaceutical ingredient or excipient supply source changes and/or assessment of associated bioequivalence requirements for the general medicines portfolio of products marketed worldwide.

The Associate Director, Biopharmaceutics will also be responsible for contributing to and reviewing clinical modules for regulatory submissions, contribute the authoring and review of Investigator Brochures, INDs, briefing books and other regulatory documents, as applicable. The Associate Director, Biopharmaceutics will be the primary author for module 2.7.1 for global regulatory submissions.

Responsibilities

+ Provide support for the Biopharmaceutics Lead on early clinical development programs to ensure optimal formulation development through assessment of pharmacokinetic performance of a given compound in context of relevant formulation, manufacturing or source of supply changes.

+ Provide support for biowaiver and/or assessment of bioequivalence requirements for formulation or manufacturing site changes for the general medicines’ portfolio.

+ Design bioavailability/ bioequivalence study synopsis for primary and global markets. Interpret study results and review study protocol and study report as the biopharmaceutics and pharmacokinetic expert

+ Identify formulation-related considerations and critical in-vitro attributes which can support predicting in vivo performance during due diligence evaluation.

+ Contribute to scientific communications, publications and internal knowledge-sharing events.

+ Contribute to and/or review the nonclinical, early clinical development or CMC documentation to support regulatory or other cross-functional activities, as needed.

+ Support interactions with Health Authorities, including meetings and submission preparation, as appropriate.

+ Support the Biopharmaceutics Lead in effective engagement with regulators, scientific leaders, and clinical stakeholders, as needed.

Required Education, Experience and Skills

+ PhD or equivalent degree in pharmaceutics, pharmaceutical sciences, biopharmaceutics, or related discipline.

+ Minimum of 3 years of experience in the pharmaceutical or biotech industry.

+ Demonstrated technical and scientific knowledge of pharmacokinetics, formulation development and biopharmaceutics, and clinical pharmacology a discipline to facilitate clinical development of drug candidates.

+ Working knowledge of early clinical development and clinical pharmacology-, modeling- and bioanalytical-related regulatory guidelines and GxP requirements.

+ Regulatory experience including the preparation of submission modules, briefing books and/or product labeling.

+ An effective communicator and exemplifies collaboration, integrity, and respectful interactions with Organon personnel as well as external stakeholders.

+ Excellent organizational and interpersonal skills.

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

+ 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 development challenges.

+ Ability to connect seemingly disparate datum or concepts to provide development insights and facilitate strategic planning.

+ Experience with management and oversight of vendors responsible for supporting various outsourced research activities.

Preferred Experience and Skills

+ Experience in Women’s Health therapeutic area is preferred.

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

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:** R536678