Associate Director, Medical Writing (Remote)

The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program. The incumbent will work with the MW program lead to ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation.

This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions as needed.

Drives and develops the messaging strategy within the clinical program to ensure effective communication (ie, protocols, submissions, briefing books, responses to HA questions) underpins successful clinical development.

• Represents medical writing on the team level to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
• Works with the MW program lead to develop a messaging strategy across a program of work
• Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.

Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).

• Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
• Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science.
• Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
• Sets program-level standards (eg, style convention)

Minimum Requirements:

• BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry
• Exceptional written and oral communication skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
• A solid understanding of the clinical development process, including the documents that are required at each stage.
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

Other Valuable Experience:

• Ability to think strategically with demonstrated negotiating skills and resourcefulness.
• Ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
• Strong influencing skills, able to lead without formal authority.
• Demonstrated ability to: work collaboratively with multicultural sensitivity, build positive and productive relationships, seek input and value differences.
• Successful track record of leading complex clinical / regulatory writing projects.
• Excellent organisational and time management skills.