Senior Scientific Review and Medical Communications Manager

California, US residents click here.

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 a collaborative communicator, sharing timely and relevant information to a variety of internal and external stakeholders.  You are able to interpret complex data, and help compliantly disseminate it with ease, across a variety of formats and audiences. 

The Senior Scientific Review & Medical Communications Manager role serves as the lead medical reviewer for pulmonary hypertension (PH) related promotional materials, sales training materials, and other materials developed for external use, such as advisory board content and non-promotional reprints to ensure compliance, scientific and medical accuracy and alignment with Company and Global Medical Affairs strategy.

• Serve as medical reviewer who is accountable for the thorough and timely review of promotional and non-promotional materials in PH therapeutic area. Collaborate with Legal, Regulatory Affairs, and Marketing to ensure effective management of medical review for promotional activities, including establishing standards and guidelines for the development and approval of materials
• Contribute to and support the development and execution of global scientific communications strategy and tactical plans for company products within specified therapeutic area
• Develop and maintain a strong understanding of unmet needs and business strategies to ensure content is aligned with current treatment paradigms, and content is suitable to the target audience
• Maintain a strong understanding of applicable compliance regulations and standards for the industry related to the development and use of promotional and non-promotional materials
• Support and attend advisory Boards to gain insights on Medical Affairs activities aligned with company objectives
• Assist in training of commercial staff on medical aspects of promotional material
• Assist in review of medical communication materials, e.g. MSL and CPL CNE slide decks and publication reviews

Minimum Requirements

• Doctor of Pharmacy (PharmD), Doctor of Philosophy (PhD) or MD
• 5+ years of relevant experience
• Previous industry in Medical Affairs, with promotional material review experience or previous experience in Regulatory (promotional review) or Clinical Development
• Proven ability to understand and articulate scientific/clinical information
• Maintain organization-wide awareness in support of therapeutic areas
• Ability to engage, negotiate, and build strong collaborative relationships with internal partners and stakeholders.
• Knowledge of and understanding of Veeva (Promomats)
• Ability to initiate and lead projects
• Excellent communication and presentation skills
• Strong attention to detail
• Ability to work well in a fast-paced environment
• Proficiency in Word, PowerPoint and Excel

Preferred Qualifications

• Board Certified Medical Affairs Specialist (BCMAS)
• Knowledge of and or experience in medical 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.

Biotechnology company focused on pulmonary arterial hypertension and organ transplant therapies. Headquartered in Silver Spring, MD.

unither.com