Senior Medical Writer

Brief Description :

The Senior Manager Medical Writing is responsible for authoring and overseeing the completion of a broad range of documents in support of company products and projects.

This individual will work with a cross functional study team to author and edit documents.

This individual will help manage documents, create and maintain document timelines, as well as ensuring that documents comply with the Jazz style guide, and SOPs as well as external regulatory requirements.

As a study team member, this individual will work with colleagues across R&D to ensure high quality documents are produced in the timeframe provided.

He / she will lead meetings to discuss issues pertaining to the documents and guide the team to successful resolution efficiently.

Essential Functions / Responsibilities

• Write and edit lean clinical regulatory documents companywide for sense, clarity, accuracy.
• Provide writing support for a wide range of documents, including investigator’s brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs.
• Work with the lead writer to create, manage and communicate the document timeline to ensure all reviews are completed in predetermined timeframe.
• Ensure that documents comply with International Conference on Harmonization guidelines, Jazz Pharmaceuticals SOPs, and Good Clinical Practices.

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
• Ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
• Experience with a variety of regulatory and clinical documents
• Experience in a matrix environment
• Excellent written and oral communication skills and demonstrated problem-solving abilities
• Ability to handle multiple projects and short timelines
• Ability to work cooperatively with colleagues in a wide range of disciplines
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
• Excellent organisational and time management skills and attention to detail

Required / Preferred Education and Licenses

BA / BS with at least 6 years (or advanced degree with at least 4 years) writing experience in the pharmaceutical industry across therapeutic areas required.

Advanced degree preferred.

FOR US-BASED CANDIDATES ONLY