Job Description
Job 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
- While some travel may be required, this role requires in-person/on-site execution from Vanda's 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
Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.
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 [click to reveal phone number]202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
Job Tags
Full time, Work at office, Monday to Friday,