Senior Manager, Global Scientific Alignment - Job ID: 1456
Ascendis PharmaAbout the role
Ascendis Pharma is a fast-growing biopharmaceutical company with offices in Denmark, Germany, and the United States. We are advancing a pipeline of endocrinology rare disease programs focused on making a difference in people’s lives. Three of our product candidates are currently in clinical development.
Ascendis is a dynamic place for employees to grow and develop their skills. As a member of our team, you can influence the direction of the company and be part of a company that creates new therapies with potential for best-in-class efficacy and safety.
Scientific Affairs is a key division within Global Medical Affairs responsible for Medical Communications, Scientific Training and Development, Medical Information, and Scientific Alignment. As a member of the Medical Affairs team, the Senior Manager, Global Scientific Alignment will ensure consistency and accuracy of core scientific messaging throughout internal and external medical materials. The Senior Manager will be a key contributor to the development of Ascendis Pharma’s Scientific Communication Platforms and lead the appropriate adaptations and guidance for the greatest impact and accuracy in local markets across Europe and US. 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 Medical and Commercial colleagues on various externally facing and internal training materials.
The Senior Manager will be the point of contact for regional content developers and medical reviewers related to the core messaging and guidance on key themes contained in external communications with disease state and Ascendis Pharma clinical data, such as Field Medical slide decks, advisory board materials, and FAQs. The individual will work closely with the entire Global Medical Affairs organization, particularly within Global Medical Strategy, Medical Information, Medical Communications, and Scientific Training and Development to develop and implement Global Medical Affairs strategy and ensures that critical scientific information is communicated with clarity, consistency, precision, and accessibility.
The position reports to the Director, Global Head of Scientific Alignment.
Key Responsibilities
- Demonstrates a command of therapeutic areas and expertise with products in hypoparathyroidism, growth hormone deficiency, achondroplasia, and other therapeutic areas in development
- Analyzes and critically evaluates scientific data in medical, non-promotional, and promotional materials
- A key contributor and project lead for Scientific Communication Platforms for aligned and strategic global scientific messaging.
- 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 Global 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 internal scientific 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 Marketing, Market Access, Regulatory, Legal, Clinical Development, Clinical Operations, Biometrics, Corporate Communications, Program Management and other functional group contributors to ensure successful alignment of communications
- 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 6 years of industry experience in Medical Communications or Medical Affairs, or as part of a Medical Communications agency is required
- 8 years of industry experience in Medical Communications or Medical Aff
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