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:             

• 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.

We seek candidates with the following qualifications:

• 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.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 150 Best Executive Recruiting Firms.