Our portfolio encompasses more than 60 medicines and products across a range of areas including reproductive health, heart disease, oncology, immunology, dermatology, allergy, and asthma. We bring these important therapies to more than 140 markets around the world.
We believe in a better and healthier every day for every woman because women are the backbone of a thriving, stable, and resilient world. We know that good health can mean more opportunity and freedom to follow her imagination, wherever it may lead. And her imagination inspires ours.
As part of our commitment to ethics and good corporate citizenship, our first step is always to comply with the laws and regulations that govern the way we market and sell our medicines and other healthcare products.
Organon & Co. is an American pharmaceutical company headquartered in Jersey City, New Jersey.[4] Organon specializes in the following core therapeutic fields: reproductive medicine, contraception, psychiatry, hormone replacement therapy (HRT), and anesthesia. Organon produces all its products outside of the United States but gets a third of its revenue from the United States. Organon & Co. is an example of increasing women's representation on Wall Street with over 50% of its board of directors and executive leadership being female.[5]
Organon was founded in 1923 as a partnership between the physiologist/endocrinologist of the University of Amsterdam Prof Ernst Laqueur and Saal van Zwanenberg (1889-1974)[6] who owned an abattoir/slaughterhouse, Zwanenbergs Slachterijen en Fabrieken, in Oss in Northern Brabant. The company's first product was insulin in 1923.[7] In the thirties it manufactured estrogens, in particular estrone under the trade name Menformon.[7]
In 1962, it bought the stock of the Nederlandsche Cocanefabriek. The company name was changed to Koninklijke Zwanenberg-Organon (KZO), and it merged with the fibre producer AKU in 1969 to become AKZO, later Akzo Nobel. Organon was the human health care business unit of Akzo Nobel. In 2004, Organon acquired active-pharmaceutical-ingredient producer Diosynth.[8]
Organon was initially located in West Orange, New Jersey.[9][10][11] In November 2007, Schering-Plough acquired Organon BioSciences and veterinary pharmaceutical company Intervet from Akzo Nobel.[12] Schering-Plough transferred Organon to its headquarters in Jersey City, New Jersey.[13] Two years later, Schering-Plough merged with Merck & Co., known as Merck Sharp & Dohme or MSD outside the United States and Canada.[14]
Their products are divided into three main categories women's health (27% of revenue), biosimilars (8% of revenue), and established brands (64% of revenue). Women's health products are mainly contraceptives such as Nexplanon, a three-year reversible contraceptive implant, and fertility drugs such as Puregon, a follicle-stimulating hormone drug.[5] Biosimilars provide treatment for oncology and immunology at potentially lower cost than other FDA approved treatments.[5][20] Organon makes the biosimilar Hadlima which it compares to Humira. Their established brands are heavily reliant on sales outside the United States of drugs with generic competition. The cardiovascular products such as Vytorin make a combined 24% of the company revenue.[5] Revenue figures stated with 2022 figures.
During its period of independent operation, Organon developed a large number of compounds which were never adopted for medical use, but continue to be used for a variety of scientific research. Notable compounds include:
In 2007, whistleblower lawsuits were filed against Organon in federal courts in Massachusetts and Texas. Organon was accused of selling its anti-depression medication Remeron at a discount to nursing home pharmacies (in order to encourage use), yet filing claims to Medicare for reimbursement at the full, undiscounted price. Organon agreed to settle the case for $31 million in October 2014.[21]
We are also focused on her future. We believe that by listening to women and focusing on research and innovations that address their unmet healthcare needs, we are working to help realize a future as unlimited as her imagination.
We build upon our strong foundation of more than 60 medicines and other products across a range of areas including reproductive health, immunology, cardiovascular disease, dermatology, allergies and asthma. And we bring these important therapies around the world, with an international footprint that serves people in more than 140 markets.
Please read the accompanying Medication Guide for HADLIMA, including the information about serious infections and cancers, and discuss it with your doctor. The Instructions for Use and Physician Prescribing Information also are available.
Please read the Medication Guide for RENFLEXIS, including the information about serious infections and cancers, and discuss it with your doctor. The physician Prescribing Information also is available.
That is why the companyprovides certain medicines for free to peoplewho do not have prescription drug or health insurancecoverage and who, without our assistance, cannot affordtheir Organon medicines. This is consistentwith Organon's commitment to putting patients first.
Organon is not associated with any individuals or organizations that may charge patients a fee to assist them in completing enrollment forms for our programs. These individuals or organizations are acting independently of Organon, and do not have Organon's consent.
During this unprecedented time, if you have lost your job and health insurance due to the COVID-19 pandemic and need help paying for your Organon medicines, the Organon Patient Assistance Program may be able to provide your Organon medicines at no cost.
Patients who do not have insurance, or who cannot afford their prescribed Organon medicine even with prescription drug coverage, may be eligible for free product from the Organon Patient Assistance Program if they meet certain financial, medical, and/or insurance criteria.
Links to other websites are provided as a convenience to the visitor. Organon accepts no responsibility for the content of linked sites. Any data you choose to provide to the linked sites will be governed by the privacy policies of those sites.
The Associate Director, Translational Medicine and Early Clinical Development (TM & ECD) is responsible for overseeing the operational aspects of translational medicine and early clinical development studies and will report into the Executive Director, Translational Medicine and Early Clinical Development Operations.\u00A0 As the operational lead for individual studies, the Associate Director serves as the primary point of contact for contract service providers (vendors) involved in study-related activities and for ensuring that the execution of all study aspects follow Organon SOPs.\u00A0 The Associate Director collaborates with internal and external scientific and medical experts to plan and execute studies that support TM & ECD program strategies and plans; author, review and/or manage a wide variety of activities, including for example, study protocols and schedule of activities, informed consent forms, case report forms, study reference manuals, monitoring plans, data management plans, and site initiation visit meeting presentations.\u00A0 The Associate Director will manage the clinical study team and help coordinate meetings and interactions with vendors to optimize communication and smooth execution of TM & ECD studies.\u00A0 The Associate Director also manages internal teams to ensure database lock activities occur in a timely manner, coordinate activities for delivery of top-line data, as necessary, and review clinical study reports in accordance with overall project timelines.\u00A0
Assist in the development of TM & ECD study protocols, including the development of the schedule of activities and associated procedures, ensuring they are implementable, and procedures are clinically appropriate and the operational aspects of the study are clearly outlined in the protocol\u2019s investigational plan.
Serve as the point of contact for study-related contract service providers (vendors), including the study contract research organization (CRO) and/or clinical study sites or other vendors, as appropriate.
Serve as the TM & ECD clinical study team lead coordinating internal and external cross-functional communication and documentation to optimize collaboration and ensure TM & ECD studies are executed with the highest standards and are conducted in compliance with the protocol, ICH/GCP, and applicable regulatory requirements.
Manage vendors to execute TM & ECD studies in accordance with contracted scope, costs and timelines; actively engage with vendors on defining, monitoring and reporting on all aspects of key trial performance indicators, including for example, country and site initiation activities, patient screening and randomization rates, and data collection activities.
Prepare vendor proposal documents and with cross-functional project team, solicit and evaluate competitive bids; lead contracting process with selected CROs, including purchase order requisitions and routing contracts for approval.
Identify risks to ensure successful execution of TM & ECD studies, proactively communicate risks to internal and external cross-functional teams and vendor teams, and lead the clinical study team to develop and implement risk mitigation strategies and tactics to enable study completion in accordance with approved timelines and plans.
A minimum of five to six years' experience in translational medicine and early clinical development within the pharmaceutical or biotech industry with a proven track record for competence and efficiency in overseeing the execution of TM & ECD (early phase 1 \u2013 2a) studies.
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