Director / Sr. Director, Scientific Communications, Medical Information and Publications
Reporting to the Vice President of Medical Affairs, the Director/Sr. Director of Scientific Communications, Medical Information and Publications will be an integral part of the Clinical Development and Medical Affairs (CDMA) team. He/she will be responsible for the oversight and function of the medical information center ensuring compliant and efficient processes for developing medical information materials and ensuring timely delivery of responses. In addition, he/she will be accountable for developing and executing the strategic publication plan for scPharmaceuticals products as well as medical review of promotional and non-promotional materials.
Summary of Key Responsibilities:
- Lead Medical Information department and manage external Medical Information Call Center to ensure compliant and efficient processes for responding to unsolicited medical information requests in a timely manner
- Systematically compiles/assesses/maintains/communicates metrics that monitor Medical Information trends
- Manage and develop custom medical information responses for escalated medical inquiries from the Medical Information Call Center
- Develop high-quality, balanced Standard Response Letters (SRLs) and Frequently Asked Questions (FAQ) ensuring accurate and up-to-date information available for scientific communications
- Represents medical function on the Medical, Legal Regulatory (MLR) Review Committee for promotional and non-promotional materials review, ensuring accuracy, relevance and completeness of scientific data, appropriateness of references cited and that communications are adequately supported by data
- Develop and maintain current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with scPharmaceuticals products and disease states
- Maintain scPharmaceuticals reference library, bibliographies and eLibrary subscriptions
- Leads/directs medical information booth activities at professional scientific meetings
- Develop and maintain AMCP Formulary Dossier, Core Scientific Slide Deck, and other scientific resources utilized by the Clinical Education and Research Liaison (CERL) team
- Develop and execute strategic publication and scientific communication plan for scPharmaceuticals Products, including disease state awareness campaigns
Education and Experience Requirements:
- Advanced scientific degree in pharmacy (PharmD) or related science (RN, NP, PhD, MD) with a minimum of 8 years of experience in experience in the pharmaceutical/biotech industry
- Cardiology/ Heart failure therapeutic expertise strongly preferred
- New product launch experience preferred
- Understands drug development, health authority regulations and reporting requirements for adverse events and device complaints
- Understands the process for developing medical information response documents using regulatory information, published medical literature, clinical study reports, posters, and abstracts
- Ability to collaborate effectively with the clinical operations team, cross functional team members and external partners including CROS, Vendors, Investigators and site staff.
- Knowledge and understanding of Good Publications Practices Guidelines, FDAMA Section 114, FDA Guidance’s on Medical Product and Drug/Device Manufacturer Communications
- Position will require some travel (10-20%)
Skills and Abilities:
- Excellent written and verbal communication skills
- Cross functional team player ensuring strategic alignment of information with key internal stakeholders and experts
- Literature searching skills through PubMed or other search engines as appropriate
- You understand, appreciate and thrive in a growing organization and have the desire to learn new skills to contribute to company success
- You can manage various projects, solve problems and deliver on commitments
- You can understand strategy, transition to execution and effectively collaborate cross functionally
- You have excellent communication, customer service and collaborative skills
- You strive for excellence and expect the same from your team and colleagues
- Accountability: You… See it. Own it. Solve it. Do it. You possess a high degree of personal responsibility with a similar expectation of your team and colleagues.
- Commitment to Patients: You have a passion for creating strategic, innovative, valuable, and high-quality solutions and products with a hands-on approach.
- Teamwork: You confer with others to reach resolutions that are acceptable by all parties involved. You can multi-task and productively manage complex situations involving cross functional teams.
- Integrity: You possess and demonstrate a high level of emotional intelligence and professionalism in your decision making. You unfailingly act with integrity and respect for colleagues, business partners and customers in all business dealings.
- Value Driven: You produce consistent, high quality and quantity of outputs and meaningful results that contribute to strategic goals.
- Empowered Communications: You possess and demonstrate strong communication and interpersonal skills.
scPharmaceuticals is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.