Associate Director, Regulatory Medical Writing
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!THIS ROLE CAN BE 100% REMOTELY BASED.
This role is accountable for Regulatory Medical Writing (RMW) and is part of the Regulatory Operations organization.
The successful candidate should expect to provide medical writing of clinical and safety regulatory documents supporting components across various types of regulatory filings, including but not limited to: Protocol Amendments for inline trials, aggregate safety reports (DSUR, PSUR/PBRER, PADER, Annual Reports), Agency Background Packages and Response to Agency Inquiry, 2.5 Clinical Overviews, Clinical and Non-Clinical expert statements, and RMPs. Other responsibilities would also include maintenance of common templates and provide content management support (i.e., formatting, citations, content authoring tool workflow facilitation).
This position will be required to coordinate routinely with leadership in the Product Registration (Regulatory Liaison) organization, Medical/Clinical/Safety organizations (with CRO), and IT.
This position will be a member of the Regulatory Medical Writing Team, reporting into Director, Medical Writer.
Interact with therapeutic/functional area leaders to execute on organizational priorities.
Ensures timely and high-quality completion of Medical Writing deliverables that include the proper content and context and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
Drive interaction and clear handoffs between stakeholder SME organizations (Clinical, Safety, Regulatory, Non-Clinical) to the RMW team.
Support and drive partnering with vendors to provide Medical Writing support.
Lead the development, alignment, and consistent implementation of processes.
Ensures appropriate systems in place such that quality assurance review of documents occurs.
Drive the preparation/revision of document templates, development of process, and preparation/revision of standard operating procedures (SOPs) and guidance documents.
Develops and drives process supporting content authoring and formatting to a standard within the global content authoring platform.
Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities.
Provides strategic direction and oversight of multiple contractor (partner) RMW’s composed of senior/experienced RMW and junior RMW roles.
Education Minimum Requirements:
Bachelor of Science Degree in Life Sciences or Health Care Professions (Nursing/ Pharmacy) or related discipline.
Master’s degree / PhD / PharmD preferred.
Required Experience and Skills:
At least 8 years of relevant pharmaceutic experience is required; with majority of this in medical writing role.
Experience as lead writer for key documents included in major US/EU and/or international regulatory submissions required.
Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
Must have proven track record to be able to think critically, strategically, independently and problem solve.
Must have high level of motivation, drive, and demonstration of our new company's leadership values.
Excellent time and project management skills.
Excellent written and verbal communication skills including ability to write clearly and concisely.
Top notch interpersonal skills in difficult situations.
Ability to collaborate across multiple functional areas.
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.
Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.
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