Scientific Affairs is a key division within Medical Affairs responsible for Medical Communications, Scientific Training and Development, Medical Information, and Strategy and Alignment. As a member of the Medical Affairs team, the Senior Manager, Medical Reviewer of Promotional Material will serve as a member of the US Promotional Review Committee. The Senior Manager ensures materials are medically accurate, fair-balanced and aligned to core scientific messaging. Further, this individual will work collaboratively with Regulatory, Legal, and Commercial to facilitate delivery of promotional materials with excellent clarity, consistency, precision, and accessibility. To foster high scientific standards, this individual will be a subject matter expert and will engage in early concept reviews, constructive discussions, and provide actionable and clear guidance for Commercial colleagues on promotional materials. The individual will work closely with the entire Medical Affairs organization, particularly within Medical Information, Medical Communications, and Scientific Training and Development, as a key contributor to medical strategy and the development of key scientific messaging in Ascendis Pharma’s scientific communication platforms.
The position reports to the Director, Scientific Strategy and Alignment and is a remote position with occasional travel to assigned meetings.
Key Responsibilities
- Represents Medical Affairs as a member of the US Promotional Review Committee
- Demonstrates a command of therapeutic areas and expertise with products in growth hormone deficiency, hypoparathyroidism, achondroplasia, and new therapeutic areas in development
- Responsible for ensuring the medical and scientific accuracy of submitted materials as well as verifying that statements are adequately supported by appropriate evidence and the cited data
- Analyzes and critically evaluates scientific data in medical and promotional materials
- Supports content development for Medical Information across products (Medical Content Letters, Custom Response Letters, FAQs., etc.)
- Provides perspective on the development and revision of SOPs, implementation guidelines (IGs), and Work Instructions (WIs) as necessary
- Contributes to the development and execution of Medical Affairs strategy and strategic imperatives across therapeutic areas
- Develops medical slide presentations for internal and external use
- Develops material for advisory boards and contributes to Congress Symposia/medical education, as appropriate
- Provides guidance for the appropriate use of scientific evidence by reviewing materials developed by external compendia (e.g., Medical Letter, MediSpan, treatment guidelines)
- Ability to research, develop, and write content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality and regulatory standards
- Supports development of training materials for Field Teams, Medical Information Call Center, and others as appropriate
- Participate in vendor selection activities and manage various vendors and associated budgets
- Works closely and develop strong partnerships with internal stakeholders including Commercial, Marketing, Regulatory, Legal, Clinical Development, Clinical Operations, Biometrics, Corporate Communications, Program Management and other functional group contributors to ensure successful management of medical communications projects
- Stays abreast of up-to-date knowledge on all clinical data relevant to all Ascendis Pharma programs, the competitive landscape, new therapies, clinical trends, and newly issued regulatory laws and FDA guidance to promptly identify possible impact, competition or improvements to product programs
Requirements
- At least 5 years of industry experience in medical communications or Medical Affairs, or as part of a Medical Communications agency required
- Advanced degree in Life Sciences (PhD/PharmD) preferred, but not required
- Previous Medical Reviewer experience preferred, but not required
- Strong organizational skills and a solid proficiency in Microsoft Suite and Veeva Vault
- Expertise in Medical Communications projects including medical field team resources, advisory boards, congress/publication plans, conference symposia, and disease state education programs
- Demonstrated expertise in writing and presenting scientific and clinical data
- Keen analytical skills, especially involving scientific and clinical data
- Exceptional ability to manage multiple projects in dynamic environment
- Ability to work well in multi-disciplinary teams
- Ability to work in teams and interface in a dynamic environment across corporate functions
- A high level of initiative a