Brief Description:

The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program.

S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.

This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities.

Essential Functions/Responsibilities

• Works with the cross functional team to ensure effective communication of data in the respective documents.

• Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle.

• Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities).

• Communicates proactively and efficiently within the MW team and across R&D.

• Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards.

• Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.

• Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.

Required Knowledge, Skills, and Abilities

• Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness.

• Clear understanding of lean authoring for clinical regulatory documents.

• A solid understanding of the clinical development process, including the documents that are required at each stage.

• For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required.

• Prior contribution to, and an understanding of, global submissions.

• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.

• Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities.

• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents

• Ability to think strategically; demonstrated negotiating skills and resourcefulness.

• Demonstrated ability to manage several projects simultaneously.

• Ability to critically analyze and synthesize complex scientific information.

• High degree of influencing skills in shaping and developing content and wording.

• Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships, seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions / proposals.

• Successful track record of leading complex clinical / regulatory writing projects.

• Demonstrated ability to make decisions even in the absence of complete information.

• An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).

• Excellent organizational and time management skills and attention to detail.

Required/Preferred Education and Licenses

• BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. Advanced degree preferred.

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