Manager, Medical Affairs Operations and Administration
Reporting to the Vice President of Medical Affairs, the Manager, Medical Affairs Operations will be an integral part of the Clinical Development and Medical Affairs (CDMA) team. He/she will be responsible for oversight and execution of Medical Affairs Operations including vendor management, field medical operations, and internal MA planning. He/She will also be responsible for administrative and strategic support of the Medical, Legal, Regulatory Review Committee (MLRC), Educational grants program, Investigator Initiated Study (ISS) Program and will also supporting MA meetings/events and procurement for the Medical Affairs team.
Summary of Key Responsibilities:
- Oversee execution of Medical Affairs operations needs including Vendor Management, Field Medical Operations (e.g. Veeva CRM management), Electronic Management System for Promotional/non-promotional material review (e.g. Veeva PromoMats) and Internal MA Communications Strategy and Planning
- Educational grants program and Investigator-Initiated Study (IIS) program lead serving as single point person to receive and review requests for completeness, prepare for and coordinate all committee meetings, maintain budgets, as well as regular communications with grant/IIS requestors to manage trackers/milestones
- Act as Medical, Legal, Regulatory Committee (MLRC) coordinator for non-promotional scientific/medical information materials and promotional materials, including responsibility for coordinating the MLRC schedule; creating review agendas; confirming the readiness of materials for MLRC review; assuring proper annotation and referencing for submitted materials and ensuring that reviewers complete their tasks in a timely fashion; taking minutes/comments during MLRC meetings; verifying MLRC comments have been incorporated into the material; and maintaining the electronic management system
- Lead MA operations for advisory board meetings, including scheduling and organizing meeting space and activities, preparing materials, leading preparation meetings, live documentation and distribution of minutes and materials
- Assist as needed with development and updates/pull through of scientific resources such as core scientific slide deck, disease state slide decks, FAQ slides, etc.
- Assist with MA consulting agreements and serve as point person for MA contracting and routing MA documents through purchasing process
- Oversee Reprints Desk / Bibliogo and act as the lead contact for ordering scientific articles for internal personnel
- Support department needs and serves as a resource
Education and Experience Requirements:
- Bachelor of Science or Health Sciences degree preferred
- Minimum of 3 years experience in the pharmaceutical/biotech industry or specific experience in lieu of this
- Must have strong writing and communication skills, high level of attention to detail and the ability to interact confidently with executives and employees at all levels
- Experience working in Veeva Vault PromoMats and Veeva CRM highly desirable
- Ability to collaborate effectively with the cross functional team members and external partners including a multitude of vendors
- Literature searching skills through PubMed or other search engines as appropriate
Skills and Abilities:
- Excellent written and verbal communication skills
- Advanced proficiency in Microsoft Word, Excel, PowerPoint, and Outlook
- Cross functional team player ensuring strategic alignment of information with key internal stakeholders and experts
- Ability to prioritize time-sensitive assignments and flexibility to adapt to ever changing needs/deadlines
- 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.