Senior Scientific Review and Medical Communications Manager

United Therapeutics•Rtp, NC

11h•Hybrid

About The Position

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

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

Nice To Haves

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

Responsibilities

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