Medical Affairs Communications Manager

Role Summary

Medical Affairs Communications Manager

Responsibilities

• Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents
• As needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents
• Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients
• Technically and intelligently read/write speaker‚Äôs presentations and commercial materials
• Participate materially and technically in the speaker‚Äôs program and training
• Engage with KOLs
• Respond to Medical Information Requests
• Ability and acumen to identify potential investigator studies
• Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents
• Lead document review meetings and discussions; providing direction and solutions to cross-functional teams on expectations for document content
• Perform QC of clinical and nonclinical documents
• Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines
• Participate in project team meetings
• While some travel may be required, this role requires in-person/on-site execution from Vanda‚Äôs headquarters in Washington, DC
• Position requires working onsite in the office five days per week (Monday through Friday)

Qualifications

• Doctoral degree required (PhD, PharmD, MD)
• 2+ years of experience creating scientific resources in a pharmaceutical or agency/vendor setting for delivery to healthcare professionals. Previous experience in Medical Affairs strongly preferred
• Medical writing and publication planning experience. CMPP certification a plus
• Scientific/clinical background in psychiatry and/or neurology required. Preference given to those with industry experience in schizophrenia and mood disorders and/or multiple sclerosis
• Detail-oriented with exemplary written communication skills, a talent for visual representation of data, and the ability to convey complex information clearly to a variety of audience types
• Demonstrated ability in project management and prioritization. Able to adapt quickly within a dynamic environment
• This position may require 10% travel, including some weekends