Director, Regulatory Medical Writing

Job Description

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 lead medical writing of safety documents such as, aggregate safety reports (DSUR, PSUR/PBRER, PADER, Annual Reports) and clinical regulatory documents supporting components across various types of regulatory filings, including but not limited to: Protocol Amendments for inline trials, 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 the Global Head of the department.

Primary Responsibilities:

• 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 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:

• Master’s degree in Life Sciences

• PhD / PharmD preferred

Required Experience and Skills:

• At least 12 years of regulatory medical writing experience is required

• 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

• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations

• Excellent word processing, SharePoint, Excel, e-mail, and online meeting tool skills

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.

Residents of Colorado: to request this role’s pay range: email: coloradopayact@organon.com

Jersey City and New York City Positions: to request this role’s pay range and benefits, email: jcnycpayact@organon.com

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

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Organon is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

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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.

Employee Status:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R510605