Senior/Medical Writer - Global Medical Affairs bei United Therapeutics

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The job details are as follows:

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH). Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF).

The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option.

Who You Are

You are creative and detail-oriented with deep expertise in regulatory submissions and writing, including clinical study reports, clinical study protocols, and investigator’s brochures. You also bring strong experience in external-facing scientific communications - such as manuscripts, posters, and abstracts – to deliver accurate and impactful scientific content. You thrive in a fast-paced, innovative company where collaboration and adaptability are crucial to success.

The Senior/Medical Writer will support Global Medical Affairs Phase 3b/4 research as well as early phase product development. Work independently to research, write, and edit abstracts, manuscripts, posters, and several regulatory documents including but not limited to: clinical study protocols and reports, Investigator's Brochures, and safety documents that may be submitted to the Food and Drug Administration and other global health authorities for publication. Collaborate with clinicians, clinical scientists, and biostatisticians to interpret study results and post-hoc analyses to ensure study objectives, results, and statistical interpretations are accurately and clearly reflected in relevant documents.

• Serve as lead author for complex clinical and regulatory documents including clinical study protocols, IBs, ICFs, CSRs, clinical narratives, PBRER/DSURs, and regulatory submission modules (e.g., CTD sections). Provide strategic input into document planning and content development to ensure alignment with clinical and regulatory goals.
• Partner with Data Management, Biostatistics, Regulatory Affairs, Clinical Operations, Safety, and Medical Monitoring to synthesize data and insights for document development. Facilitate cross-functional review cycles and ensure timely delivery of high-quality documents.
• Collaborate with external HCPs, KOLs, CROs, and Global Medical Affairs scientific leads to author peer-reviewed manuscripts, scientific abstracts, posters, and presentations. Lead the development of scientific slide decks and educational materials for HCP engagement and congress presentations.
• Establish and maintain document tracking systems and contribute to continuous improvement of medical writing processes. Ensure consistency in scientific messaging and style across related documents and programs.
• Contribute to the creation, revision, and governance of clinical and medical writing SOPs. Ensure adherence to internal style guides, regulatory guidance documents, and industry best practices.
• Author technical reports, briefing documents, and other materials to support early-phase clinical development and regulatory interactions
• Provide guidance and mentorship to junior writers and review documents for scientific integrity, clarity, and consistency
• Support ad hoc writing needs and complex initiatives as required

Minimum Requirements

• Medical Writer - Bachelor’s Degree in a science-related field with 5+ years of experience in medical writing
• Senior Medical Writer - Bachelor’s Degree in a science-related field with 5+ years of experience in medical writing
• Excellent interpersonal skills
• Attention to detail

Preferred Qualifications

• Master’s Degree in a science-related field with previous medical writing responsibilities or
• Doctor of Philosophy (PhD) or PharmD with previous medical writing responsibilities
• 2+ years of experience in managing and directing complex and broad medical writing projects
• 2+ years of experience in global/regional regulatory medical writing for clinical studies, marketing authorization, and late phase procedures in accordance with International Council for Harmonization (ICH) E3 and E6 (R2) guidelines
• 2+ years of experience in medical communications writing

Job Location

This position will be located in the RTP, NC office of United Therapeutics. Currently this job is a hybrid role requiring at least three days per week in the office. In office requirements could increase based on business needs.

At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good.

Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities

United Therapeutics  Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities.