Director, Medical Writing

3 weeks ago

Boston MA, United States Zentalis Pharmaceuticals Full time

Zentalis Pharmaceuticals is a San Diego based pharmaceutical company dedicated to the discovery and development of small molecule therapeutics targeting fundamental biological pathways of cancer. Since our inception, we have successfully cleared four INDs with the FDA. We believe our deep pipeline of oncology therapeutics has the potential to significantly improve the lives of patients with various types of cancer.

JOB SUMMARY:

The Director, Medical Writing will provide strong technical expertise in Medical Writing and will develop, enlarge, supervise and train the medical writing group within Zentalis as needed. This position will be accountable for managing resources and work assignments of internal staff, external contractors, and vendors in order to meet timelines and budget.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Manages day-to-day medical writing team operations, both internally and externally.
  • Manages resources, including contractors, within the teams with regards to company templates, standards, and processes.
  • Assists Clinical Leads with managing documents through the review and approval process.
  • Provides medical writing support for oncology programs by leading the preparation of and/or hands-on writing of protocols, protocol amendments, CSRs, IBs, DSURs, and other documents.
  • Critically reviews documents produced by internal external writers for scientific content and alignment with company position, clarity, accuracy, and consistency.
  • Assesses and develops new and/or revises existing processes to facilitate the writing and review of documents.
  • Provides training and professional development to subordinate staff.
  • Position is essential to the company to meet key project objectives, including planning, evaluating, and managing vendors.
  • This position will also be responsible for participating in the development of templates, SOPs, and SWPs that are relevant to the Medical Writing function.
  • Will participate in functional protocol review and support study teams to maintain quality and consistency of protocols as well as study synopses and related documents.

EDUCATION/KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

  • Advanced degree in life sciences.
  • At least 8-10 years medical writing experience; previous experience in oncology is a plus.
  • 3-5 years leadership experience managing medical writers as well as outside resources; experience managing outside resources is a must.
  • Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and/or clinical data.
  • Strong project management and leadership skills; ability to coordinate the efforts of team members according to timelines.
  • Strong attention to detail and drive to produce high-quality documents.
  • Proficient in Microsoft Project and Excel a plus.
  • Excellent written and verbal communication skills.
  • Exceptional influencing, partnership, and collaboration skills.
  • Strong ability to prioritize workload.
  • Well-prepared, competent, and confident when interacting with senior management and internal and external partners.
  • Able to prospectively identify potential problems and to partner effectively and positively to solve issues.
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