Associate Director, Medical Writing
Our client is a clinical stage biopharmaceutical company. They have asked us to assist them in their search for an Associate Director, Medical Writing.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Leads planning, authoring, and critical review of regulatory documents as required.
- Contributes to the strategic planning, authoring, and critical review of scientific data disclosures.
- Contributes to preparation of graphical data visualizations from tables and listings as needed for internal or external presentations.
- Engages with external stakeholders such as vendors, thought leaders or other groups as needed.
- Develops and manages timelines for authoring, review and finalization of critical documents and associated deliverables.
- Functions as an independent member of the team and represent Clinical Research and Medical Affairs.
- Other duties related to clinical development of EFX, or medical affairs initiatives as assigned.
- Must have an advanced scientific degree in the life sciences field.
- Requires at least three years of medical writing experience in the biotechnology or pharmaceutical industry.
- Previous industry experience as a clinical scientist or medical writer is preferred.
- Experience preparing clinical protocols, study reports, IND, IB, NDA/CTD documents is preferred.
- Experience in hepatology, gastrointestinal, or endocrinology fields is preferred.
- Must be familiar with GCPs, ICH guidelines and FDA/ EMA/CHMP regulations.
- The ability to compile data, initiate drafts or edit existing documents to deliver high quality products is required.
- Familiarity with using templates and adhering to style guides is required.
- Requires the demonstrated ability to author or oversee regulatory documents.
- Must have strong interpersonal and communication skills with a proactive approach.
- Expertise in navigating scientific literature, interpretation of data, display of data is required.
- Must have demonstrated problem solving skills, a strong sense of urgency, attention to detail, and the ability to execute under time and resource pressures.
- Must be able to work both independently and in a team environment.
- Must be detail-oriented, with good organizational, prioritization, and time management proficiencies, and able to work on multiple projects simultaneously.
- Must be highly proficient in MS Office Suite.
- Requires the ability to travel if needed (<30%).
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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