Organon was established in 2021 as a new independent company with wide range of Women’s Health, trusted Legacy Brands, and Biosimilars businesses. The new company has become a publicly traded company in June 2021 with its global and US headquarters to be based in Jersey City, New Jersey, USA. We aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing.
For this exciting new opportunity, we are seeking candidates with an entrepreneurial and learning spirit who are interested in a career of purpose, personal growth and leadership. Working together, we will make a significant impact on the health and lives of people around the world.
Position Overview:
This position would be responsible for performing defined submission activities, processes and systems, interaction with working groups, proposing plans and participate submission staff meetings, identifies impediments, and collaborates with the management to build team solutions.
Major Activities:
- To ensure receipt of all requests from the countries for defined submission activities, proceses and systems and to schedule on time execution
- To proceed and oversee end to end process accuracy by thoroughly checking the records and confirmation for final execution
- To ensure work accuracy by proactively seek for support, help clarification from the responsible person if needed.
- Acquire working knowledge of department technology tools and knowledge of Standard Operating Procedures (SOP)
- To keep accurate records for all completed daily activities
- To understand both lawful and scientific aspects as required, as well as the ability to handle new ideas quickly
- Ability to pay close attention to details in order to thoroughly review processes and data and identify issues
- Maintain current knowledge of regulations and other issues that affect products and industry
- Fax, scan and copy documents. Type documents, reports and correspondence
- Receive, sort and distribute incoming mail. Prepare outgoing mail for distribution for regulatory department
- Assist with any additional duties, responsibilities or special projects as requested by the by Line Manager / other managers or Managing Director
Qualifications, Skills & Experience Required:
- A bachelor’s degree or last year bachalor’s degree candidate in pharmacy or eqivalent in biomedical scienses
- Excellent communication skills ability to work effectively in a demanding environment
- Exceptional organizational & administrative skills
- Solid knowledge Word, Excel, PowerPoint. Good computer skills and strong writing skills to produce technical documents.
- Apply Microsoft Office programs and the company’s systems relevant to area of responsibility to deliver against project strategy
- Ability to deal with wide variety of sensitive and confidential matters
- Demonstrate high responsibility, professionalism, meticulousness and attention to details in all matters including multitasking
- Have a compliance mind-set with strong focus on adherence to industry guidelines, Company policies and financial transparency
- Ability to organize and prioritize tasks and to manage high workload to work well under pressure
- Pro-active/flexible/discrete mindset
- Effective interpersonal skills
- Problem solving and decision making
- Team player with ability to work in a diverse multinational environment
- Focused on customer needs
- Fluent English
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