Responsibilities

• Lead Medical Information (MI) support for assigned pipeline assets, including development of processes and SOPs for intake/triage of unsolicited inquiries, development of scientifically balanced responses, and documentation of inquiry handling. Maintain the Medical Information (MI) content library (e.g., SRLs, FAQs, and non-standard response letters) across pipeline assets.
• Drive Medical Communications (MC) for assigned pipeline assets in partnership with internal stakeholders and external vendors/agencies, including development of the scientific platform and creation/review of scientific communication deliverables (e.g., slide decks, congress materials, FAQs, field medical materials) through MRC review and warehousing.
• Lead publications planning and execution for assigned pipeline assets in alignment with Good Publication Practice (GPP) and authorship standards (e.g., ICMJE), including publication plan development, review committee coordination, and support of abstracts, posters/orals, and manuscripts with external authors.
• Engage and maintain relationships with external scientific stakeholders (e.g., investigators, KOLs, and societies) to support publication and trial site support activities as needed.
• Ensure all activities adhere to applicable regulations and company policies, including appropriate use of approved materials, documentation standards, and medical/legal/regulatory review requirements.
• Maintain scientific expertise in relevant disease areas with the ability to translate complex data into clear, audience-appropriate scientific content.
• Execute Field Medical-aligned activities for assigned ALPHA3 global study sites in, (e.g., site education and/or scientific discussions as requested).
• Other duties as assigned.

Requirements

• Advanced degree in life sciences field (APN, PhD, PharmD, MD)
• 4-6+ years of experience in Medical Affairs (Medical Information, Medical Communications, Publications, or a combination), within the pharmaceutical/biotech industry; experience supporting pipeline/launch readiness preferred.
• Working understanding of medical affairs principles, the end-to-end lifecycle of scientific content (e.g., MI response documents, medical communications materials, and publications), building HCP relationships, and engaging in scientific exchange.
• Willingness to travel (up to ~40% of time, including overnight travel) to support global ALPHA3 sites and attend internal meetings and scientific congresses, as needed.
• Excellent communication, presentation, and time management skills required; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organization
• Familiarity with applicable legal, regulatory, and compliance requirements for scientific exchange and clinical trial site interactions; ability to operate compliantly across multiple geographies.
• Ability to partner with key internal stakeholders to understand key objectives and to drive plans that achieve or exceed these
• Ability to effectively work in a fast-paced, biotech environment, while dealing with ambiguity and ability to work independently and as part of a team
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines and strong interpersonal skills including verbal and written communication are essential in this collaborative work environment
• Candidates must be authorized to work in the U.S. and able to travel internationally for business (i.e., obtain/maintain a valid passport and any required visas/entry documentation, as needed).

Preferred

• Experience supporting pipeline/launch readiness is preferred.

Benefits

• annual performance bonus
• equity
• health insurance
• generous time off (including 2 annual holiday company-wide shutdowns)