Manager, Medical Affairs Operations and Administration

The Manager, Medical Affairs Operations and Administration will be an integral part of the Clinical Development and Medical Affairs (CDMA) team and the lead coordinator of the Medical, Legal, Regulatory Review Committee (MLRC). 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 manage and coordinate all MLRC activities and serve as an administrator in associated documentation systems. He/She will also be responsible for administrative and strategic support of the Educational Grants program, Investigator Sponsored Study (ISS) Program and will also support MA meetings/events and procurement for the Medical Affairs team.
This role will report to the Vice President, Medical Affairs with a dotted line to the Vice President, Regulatory Affairs.
 
Responsibilities:
  • Oversee execution of Medical Affairs operations needs including Vendor Management, Field Medical Operations (e.g. Veeva CRM management), Medical Information systems (e.g. Veeva MedInquiry), Electronic Management System for Promotional/non-promotional material review (e.g. Veeva PromoMats) and Internal MA Communications Strategy and Planning 
  • Supports Educational Grants Committee and Investigator Sponsored Study (ISS) program serving as single point person to receive and review requests for completeness, prepare for and coordinate all committee meetings, develop meeting minutes, maintain budgets, and perform follow-up as needed, including regular communications with grant/ISS requestors to manage trackers/milestones and reconciliation needs 
  • Support Medical Affairs leadership in dashboard and reporting needs relative to Field Medical Affairs activities and Medical Information
  • Support CERL Promotional Speaker program needs including ensuring all HCP attendees are correctly entered into VEEEVA CRM from customer data master (Mosaic).
  • Lead Field Medical operations systems training and optimization of MA operations systems (VEEVA CRM, Mosaic, Reprints desk, etc.)
  • Assist Publications with authorship agreement execution consistent with Good Publication Practice Guidelines
  • 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
  • Provide support for KOL lecture series including contracting, HCP travel, scheduling, and other needs
  • Oversee Reprints Desk/Bibliogo and act as the lead contact for ordering scientific articles for internal personnel 
  • Assist as needed with development and updates/pull through of scientific resources such as core scientific slide deck, disease state slide decks, Standard Response documents, FAQs, and others as needed. 
  • Coordinate and manage Medical, Legal, Regulatory Committee (MLRC) for non-promotional scientific/medical information materials and promotional materials, including responsibility for coordinating and tracking the MLRC schedule and processes; managing and maintaining material tracking software and reports; creating weekly review agendas and leading MLRC meetings; 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 internal administrator for Veeva systems including PromoMats, CRM, and VEEVA Med Inquiry. Manage accounts and permissions, support updates, and troubleshoot issues in Veeva systems to ensure processes and workflows function as intended to meet company needs. Coordinate with Veeva support as required to address more complicated issues.
  • Review regulatory submission documents to ensure compliance with internal document style guidelines. Provide support to Regulatory Affairs Manager for final (regulatory compliance) review of FDA regulatory submissions (including IND modules, NDA modules, periodic reports, FDA forms, etc.), as needed. 
  • Assist with MA and MLRC consulting agreements and serve as point person for MA and MLRC contracting and routing MA and MLRC documents through purchasing process 
  • Support department needs and serves as a resource 
 
Required Expertise Competencies:
  • Bachelor of Science or Health Sciences degree preferred 
  • Minimum of 3 years of experience in the pharmaceutical/biotech industry or specific experience in lieu of this 
  • Knowledgeable/Expert written and verbal communication, a high level of attention to detail, and the ability to interact confidently with colleagues at all levels 
  • Knowledgeable in Veeva Vault PromoMats, Veeva MedInquiry, and Veeva CRM and willingness to develop expertise with training.
  • Knowledgeable in project management tools and techniques and experience in coordination of multidisciplinary teams, including external vendors
  • Knowledgeable in literature searching skills through PubMed or other search engines as appropriate
  • Knowledgeable/Expert in Microsoft Word, Excel, PowerPoint, and Outlook
 
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: Ability to prioritize time-sensitive assignments and flexibility to adapt to ever changing needs/deadlines. 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: Understands, appreciates, and thrives in a growing organization and has the desire to learn new skills to contribute to company success. 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
  • Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions

Expectations:

  • This position is hybrid with a minimum of two days per week in Burlington, MA office, between Tuesday and Thursday. Additional time in the office could be required as circumstances dictate.

Apply Here!

EEO Statement:

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.