Full-Time Principal Medical Writer, Global Medical Writing

What’s In It for You:
This is an exciting leadership opportunity. The role provides the ability to influence company leaders and work on exciting drug development programs. This is your chance to join a dynamic Medical Writing team.

The Role:
The Medical Writing team is looking for an experienced individual to serve as Principal Medical Writer. The individual will be the lead writer across programs/submissions that are part of the growing clinical pipeline.In this role, the individual will be responsible for independently writing and managing clinical study-related documents including, but not limited to, clinical study protocols, master protocols, Investigator's brochures, and clinical study reports. The individual will lead cross-functional teams in development of regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents.

What You’ll Do:

• Medical Writing lead for one or more clinical programs, leading the planning, development, and implementation of content strategy for clinical and regulatory documents
• Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentation
• Author and manage the preparation of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes
• Drive document strategies and messages in a collaborative way with relevant project team subject matter experts
• Maintain cutting edge knowledge base of current developments in field and related technologies.
• Incorporate process improvements and changes that align with R&D needs
• Excellent written communication skills, detailed-oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines
• Plan and coordinate work with in-house Medical Writer team and outside CROs
• Mentor junior members of the team, providing guidance and expertise in medical writing
• Strong team player and a change agent who further reinforces/enhances cultural values
• Experienced and skilled in performing medical literature searches
• Perform reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed

PhD or equivalent plus 5+ years of experience or Bachelors/Masters plus 10+ years of experience Expert knowledge of and experience in preparing high quality clinical and regulatory documents Knowledge of clinical trial disclosure Submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in preparation of summary documents Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy Strong organizational/prioritization skills for the management of multiple concurrent documents Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please ReviewOncology, immunology, and/or neurology experience is highly preferred.

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