Team Lead, Regulatory Writing

Company: Alimentiv Inc.
Location: New York
Posted on: February 25, 2021

Job Description:

Team Lead, Regulatory Writing Medical Research and Development -- New York, New York POSITION TITLE: Team Lead, Regulatory Writing POSITION LOCATION: Canada or US (Home-based) POSITION REPORTS TO : Manager, Scientific Writing DEPARTMENT/UNIT NAME: Medical R&D JOB SUMMARY: Provide scientific writing services to Clinical Research Scientists, Academic partners, Sponsors and/or the organization, which may include researching, writing, reviewing and editing scientific information, conducting/verifying citation/reference searches, translating complex technical research data and findings into academic/scientific publications, protocols and presentations on a timely basis that align with industry, regulatory and academic style and content guidelines and standards. Provide leadership and expertise to other document writers, particularly those involved in regulatory document preparation and publishing. AREAS OF RESPONSIBILITY: Clinical Research/Academic Writing Support

• Lead the content planning and production of written research findings, study protocols, or other regulatory documents, in alignment with established standards and guidelines
• Determine the writing strategy including resource requirements, required content and format, development timeline.
• Work with authors, technical specialists, or other Scientific Writers to coordinate the completion of specialized content. Translate, write, edit, and/or proof data and content (including exhibits, illustrations, and appendices) for publication into finished documents appropriate for the stated audience
• Coordinate functional and quality control reviews to ensure high quality of deliverables
• Regularly provide progress reports to stakeholders
• Support transition to the Operations team for new study protocols Unit Operational Leadership
  • Manage the Scientific Writing Team ensuring the area is adequately staffed with qualified personnel
  • Provide ongoing support to the team in the areas of work allocation, resource planning, training and development, process development, expense management, engagement, and performance management.
  • In conjunction with the Manager, Scientific Writing plan, lead, budget for and manage the deployment of all Regulatory Writing related programs and initiatives and ensure timely project delivery and high quality.
  • Work with internal staff and where necessary, external vendors/providers to ensure all Scientific Writing related services are delivered per company guidelines Special Projects
    • Other special projects/duties as assigned QUALIFICATIONS:
      • Post-graduate Degree in Health/Life Sciences, Writing, or related discipline is preferred
      • Minimum of 5-7 years of experience in Regulatory Writing
      • Highly refined written/verbal communication and relationship building skills
      • Familiarity with wide and evolving regulatory requirements in addition to clinical, methodological, statistical, writing practices and project management. WORKING CONDITIONS:
        • Home-based *Accommodations for job applicants with disabilities are available

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