Senior Specialist, Regulatory Medical Writing

Job Description

The Position

This role is accountable for regulatory medical writing (RMW) to support Organon’s clinical development programs.

• 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 include maintenance of common templates and provide content management support (i.e. formatting, citations, content authoring tool workflow facilitation).
• This position coordinates routinely with leadership in the Product Registration (Regulatory Liaison) organization, Medical/Clinical/Safety organizations (with CRO), and IT

This Position is Remote.

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.
• Writing, editing, and formatting of regulatory documents; project management; preparation of SOPs, templates, and guidance documents; serve as medical writing subject matter expert within asset development teams; oversee contractor work.
• 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).

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Required Education, Experience and Skills:

• 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.
• At least 5 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.
• Masters degree in Life Sciences/PhD/PharmD or Health Care Professions (Nursing/ Pharmacy) or related discipline.

Preferred Education, Experience and Skills:

• Master’s degree / PhD / PharmD preferred.

Secondary Job Description

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.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. 

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.

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. 

Annualized Salary Range

Annualized Salary Range (Global)

Employee Status:

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: