Medical Affairs Communications Manager

Vanda Pharmaceuticals; Washington (District of Columbia); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Unlimited paid time off

401k matching program

Parental leave

Paid holidays

Job summary

A leading pharmaceuticals company in Washington, DC is looking for a Medical Affairs Communications Manager. This role involves writing and editing clinical regulatory documents and working closely with cross-functional teams. Candidates should possess a doctoral degree and 2+ years of relevant experience in Medical Affairs. The position requires in-person work at headquarters five days per week and may involve limited travel.

Qualifications

• 2+ years of experience in creating scientific resources for healthcare professionals.
• Experience in Medical Affairs strongly preferred.
• Detail-oriented with exemplary written communication skills.

Responsibilities

• Write, edit, and finalize regulatory documents.
• Engage with Key Opinion Leaders (KOLs).
• Conduct Quality Control of clinical and non-clinical documents.

Skills

Medical writing

Communication skills

Project management

Scientific knowledge

Education

Doctoral degree (PhD, PharmD, MD)

Tools

CMPP certification

Job description

Overview

Medical Affairs Communications Manager role at Vanda Pharmaceuticals. In-person/on-site execution from Vanda’s headquarters in Washington, DC, five days per week.

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’s presentations and commercial materials
• Participate materially and technically in the speaker’s 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
• Position requires working onsite in the office five days per week (Monday through Friday)
• Some travel may be required

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

Compensation and Benefits

The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law. If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.