We are currently seeking a Director of Medical Writing to lead medical writing. In a position that is both “hands on” and strategic, the successful candidate will provide medical writing support for NiKang’s clinical programs and will oversee external resources, as needed, to ensure the production of high-quality clinical and regulatory documents that support our product development and global registration efforts.

Essential Functions and Responsibilities:

Medical Writing:

  • Oversee the creation and revision of clinical and regulatory documents including but not limited to protocols, protocol amendments, Investigator's Brochures, study reports, informed consent forms, layperson summaries, and briefing documents.
  • Ensure documents are well-organized, accurate, consistent, and in compliance with applicable company SOPs and other guidance documents and regulations.
  • Collaborate with cross-functional teams, including clinical operations, clinical sciences, regulatory affairs and biostatistics to ensure alignment and accuracy of data.
  • Work closely with team members to author relevant sections of documents, coordinate reviews, adjudicate comments, and lead round-table discussions effectively and efficiently

Standards development:

  • Develop and implement medical writing processes and standards, including standard program lexicon, templates and writing standards, to improve efficiency and document quality.
  • Develop processes for writing, reviewing, and storing documents, as applicable.
  • Stay abreast of industry best practices and regulatory requirements related to medical writing.

Project Planning and Management:

  • Build a near-term and long-term plan of medical writing activities and plan and coordinate external medical writing resources, as needed.
  • Maintain timelines and workflow of writing assignments.
  • Represent Medical Writing on multiple project teams and serve as a subject matter expert on clinical development documents.

Supervisory Responsibilities:

  • Plan for, procure and manage external medical writing resources.

Education and Experience Required:

  • BA/BS in a life science discipline, minimum; advanced degree (Ph.D., M.D., Pharm.D., MA/MS) in a life science discipline preferred.
  • Minimum of 5 years of medical writing experience in the pharmaceutical or biotech industry (which may include work at a CRO) with experience in preparation of clinical/regulatory documents is required; experience in Oncology drug development is preferred.
  • Proven track record of managing multiple concurrent medical writing projects.

Required Skills and Abilities:

  • Expert in Microsoft Word, SharePoint and related word processing, collaboration, and electronic publishing tools.
  • Strong working knowledge of Microsoft Excel and PowerPoint.
  • In-depth understanding of regulatory requirements and guidelines for clinical documents, ensuring compliance in all medical writing activities.
  • Detail oriented with a commitment to delivering high quality, consistent, accurate and compliant clinical documentation.
  • Strong communication, collaboration, facilitative leadership, and organizational skills.
  • Able to interpret statistical analyses of clinical data.
  • Able to work independently and as part of a team.
  • Able to plan for, prioritize and manage multiple projects in a fast-paced, entrepreneurial environment.
  • Excellent oral and written English communication skills.

Position Type/Expected Hours of Work:

This is a full-time position (40 hours/week). Position is fully remote with minimal travel requirement.

Other Information:

NiKang currently anticipates the annual base salary range for this Director-level role is estimated to be from $185,000 to $225,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401(k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short-term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.

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