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Harmony Biosciences Holding, Inc. Senior Manager, Medical Information in Plymouth Meeting, Pennsylvania

Reference #: 1372 Harmony Biosciences is recruiting for a Senior Manager, Medical Information in our Plymouth Meeting, PA location. In this role you will serve as a key medical resource within Harmony Medical Affairs.  The Senior Manager creates and communicates balanced medical information compliant with industry best practices and applicable regulatory guidelines in the US, as well as represents Medical Affairs on the Promotional Review Committee (PRC). As a member of the Medical Affairs team, the Senior Manager maintains a high level of scientific knowledge and collaborates with numerous internal and external stakeholders to support Harmony Biosciences products.

Responsibilities include but are not limited to: Interpret and utilize scientific data to create written medical information documents (e.g. standard response letters, custom response letters, AMCP dossiers) used in response to unsolicited inquiries from healthcare professionals and consumers Develop and maintain a database of standard response letters (SRLs) to ensure dissemination of Harmony's medical information is timely, balanced, and scientifically accurate Manage internal review process for SRLs, CRLs and FAQs Oversee Medical Information Contact Center vendor regarding inbound medical information inquiries, medical writing, and other day-to-day activities Provide guidance on escalated cases from the Medical Information Contact Center Provide disease state and product training to Contact Center staff Contribute to or lead the creation and review of medical communications content, including disease- and product-related slide decks, digital/web-based medical content, and Medical Science Liaison resources for scientific exchange Perform scientific/medical review of promotional materials for assigned product(s)/therapeutic area(s) Actively participate in Promotional Review Committee meetings Monitor emerging relevant scientific publications through biomedical literature database searches Monitor medical information inquiries for trends and insights and report to relevant internal stakeholders Become and remain well-versed in the understanding of assigned therapeutic area, including product knowledge, disease state management, new therapies, and competitive landscape Support product launch and lifecycle activities, including attendance at Medical Congress Medical Information booths Lead the compendia submission process for Medical Affairs Collaborate with Medical Director and other members of the Medical Affairs team regarding Medical Information response documents and other Medical Affairs initiatives as needed Develop cross-functional relationships with key internal stakeholders including Regulatory Affairs, Legal, Quality Assurance, and Marketing Conduct product and adverse event training for sales representatives and commercial partners

Qualifications: Bachelor's degree required; Advanced scientific degree (MS, PharmD, MD, or PhD) strongly preferred 5+ years of experience in pharmaceutical Medical Information is required Ability to read, understand and translate clinical study reports and interpret scientific data Experience creating and reviewing scientific content (e.g. slide decks) Experience leading cross-functional teams or projects is preferred Excellent written and oral communication skills Proficiency with MS-Office Suite, Veeva, PowerPoint and Adobe Acrobat

Physical demands and work environment: Domestic travel is estimated to be up to 10% of the time. Occasionally required to sit for extended periods of time. While performing the duties of this job, the noise level in the work environment is usually quiet

What can Harmony offer you? Medical, Vision and Dental benefits the first of the month following start date Generous paid time off and Company designated Holidays Company paid Disability benefits and Life Insurance coverage 401(k) Retirement Savings Plan Paid Parental leave Employee Stock Purchase Plan ( SPP) Company sponsored wellness programs Professional development initiatives and continuous learning opportunities A certified Great Place to Work for six consecutive years based on our positive, values-based company culture

Want to see our latest job opportunities? Follow us on LinkedIn! Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com

Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

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