Manager, Medical Information
The Medical Information Associate/Specialist supports the development and distribution of clinically accurate medical and technical information in response to Medical Information Requests (MIRs) from health care professionals, patients, and payers on marketed products. This includes intake of information, triaging product complaints to quality assurance and adverse events to pharmacovigilance, researching inquiries, responding to questions accurately and timely, documenting calls and analyzing metrics according to organizational and regulatory guidelines. He/She contributes to the creation and maintenance of the product knowledge database used in responding to MIRs related to company products. In addition to intake of MIRs, this individual will collect relevant information and follow up as appropriate in the event an adverse event and/or product complaint is reported. Interpersonal skills and technical product knowledge and expertise are critical to responding to daily customer-centric activities. This position reports to the Sr. Director, Scientific Communications, Medical Information and Publications
- Responds accurately and professionally to technical and medical information inquiries received via phone, email, internet, or mail in reference to scPharmaceuticals products.
- Identifies, records and triages adverse events and product complaints according to organizational, client and regulatory guidelines and provides additional support (including follow up) as needed.
- Systematically compiles/assesses/maintains/communicates metrics that monitor Medical Information trends.
- Manages and develops custom medical information responses when warranted.
- Develops high-quality, balanced Standard Response Letters (SRLs) and Frequently Asked Questions (FAQ) responses. This includes updating of existing SRLs and FAQ documents as well as MLR submission and follow through to ensure accurate and up-to-date information is available for scientific communications.
- Assists with development of scientific resources utilized by the Clinical Education and Research Liaison (CERL) team and MA team.
- Provides product trainings to patients, caregivers and HCPs, as well as business partners (e.g. specialty pharmacies) when needed and facilitates responses to clinical trial information questions.
- Analyzes caller’s questions to formulate an accurate and concise response using MLR approved resources.
- Manages and records inquiries and interactions in appropriate databases following organizational and regulatory guidelines.
- Maintains knowledge of project and corporate policies and procedures including client products, SOPs, protocols, GCPs, and all applicable regulatory requirements.
- Works with internal and external client contacts to resolve inquiries and when needed researches medical literature and drafts responses for such inquiries.
- Assists field medical colleagues who receive unsolicited inquiries and request medical information support.
- Provides administrative support to Medical Affairs team as needed.
Required Expertise Competencies:
- Advanced scientific degree in pharmacy (PharmD) or related science (RN, NP, etc.); Fellowship in Medical Information desirable
- Experience in the pharmaceutical/biotech industry and PV/Medical Information preferred.
- Understands the process for developing medical information response documents using regulatory information, published medical literature, clinical study reports, posters, and abstracts.
- Familiarity/experience with Veeva Med Inquiry is desirable.
- Basic understanding of drug safety concepts and regulations.
- Knowledge and understanding of Good Publications Practices Guidelines, FDAMA Section 114, FDA Guidance’s on Medical Product and Drug/Device Manufacturer Communications
Required Power Competencies:
- Teamwork & Leadership: Functional influencer; builds effective partnerships and works collaboratively with others to meet shared objectives; knowledge of company structure; deliberately includes and inspires colleagues and team members
- Execution: Consistently directs, drives and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work
- Solution Maker: Dissects functional work/process issues to discover opportunities for improvement; leverages resources to deliver function-level solutions/improvements; begins building internal and external networks; demonstrates courage to ask questions, try new things, and provide feedback
- Continuous Improvement: Creates new ways for self and team to be effective; proactively leverages resources where appropriate; early adopter and implementer of technology and student of industry
- Self-Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions
- Excellent written and verbal communication skills
- Ability to think critically and use scientific background to formulate clinically accurate and balanced written and verbal communications
- Strong customer service orientation
- 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.
- Detail-oriented with proven ability to prioritize and manage various projects, solve problems, and deliver on commitments
- 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. It is the Company’s policy and intent to provide equal opportunity in employment, development and advancement without regard to a race, color, religious creed, sex, pregnancy, sexual orientation, gender identity, age, national origin, physical or mental disability, genetic information, ancestry, military service or veteran status, marital status or any other category protected under applicable federal, state or local law.