• Job Description

  Req#: 13515

  We are seeking a highly skilled Director of Medical Writing to lead our team in creating high-quality clinical and regulatory documents, collaborating with cross-functional teams, and ensuring adherence to industry guidelines. This role involves strategic resource planning, professional development of writers, and representing Medical Writing in interdepartmental planning.

  Qualifications

  • Ph.D. in Life Sciences, or M.Sc./MPH with 8 years of experience as a medical writer
  • Supervisory experience leading teams working on early and late phase studies (Phases 1-3)
  • Experience in psychiatry/ neurology therapeutic areas is a plus

  Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

  #LI-MB1

  Responsibilities

  • Provide leadership managing team of in-house and external Medical Writers
  • Work with leads from various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project Management in planning and preparation of high quality clinical and regulatory documents within assigned time frames
  • Collaborates with cross functional team on the development and/or revision of protocols, protocol amendments, clinical study reports, clinical sections of regulatory submission documents, investigator's brochures, etc. Will be responsible for direct authoring of priority study level documents in addition to supervision of other medical writers and editors
  • Guide team of external and in-house Medical Writers in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
  • Lead team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices
  • Represent Medical Writing on clinical governance committees as well as at times on Project Teams
  • Assist in the professional development of Medical Writers and/or Editors. Models rigorous and disciplined approaches to medical writing. Communicates a philosophy which strikes a proper balance between high production and high quality. Helps writers to utilize their strengths and work around their weaknesses
  • Responsible for resource planning and allocation for projects under their direction. This includes forecasting of medical writing needs through analysis of clinical development plans, and monitoring of changes in those plans. Identifies time periods when resources will be taxed and makes plans accordingly
  • Regularly reviews the department's operations to improve effectiveness and efficiency. Develops and oversees the implementation of solutions or directs others to do so. Participates in initiatives aimed at process improvement and handles novel or complex assignments
  • Plays an important role in cross-functional teams. Must be highly skilled in representing the Medical Writing group in the interdepartmental planning of clinical projects, including regulatory submissions. Demonstrates exceptional ability to collaborate
  • May be responsible for the management of medical writing resources for multiple development projects. Establishes and enforces timelines for multiple projects and writers. Plays a key role in negotiating timelines for primary projects throughout the organization
  • Collaborates with other departments to construct timelines and guidelines for the review of summary documents

  
  Technical Skills:

  • Supervisory experience in managing teams
  • Experience in working with cross-functional teams
  • Must have an in-depth expertise in clinical research and medical writing in particular. Acts as an authoritative resource on medical writing and other areas in clinical research. Ability to influence project strategy and document construction. Demonstrated ability to analyze and resolve complex problems
  • Must show a broad understanding of clinical research processes, and a familiarity with regulatory processes, along with an in-depth knowledge of other clinical functional areas. Strong understanding of other clinical functions is needed to recognize and appreciate how other departments interact with, and are dependent on, Medical Writing

  Personal Skills:

  • Excellent interpersonal and communication skills
  • Flexibility/adaptability to work in a fast-paced and dynamic environment

• About the company

  Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines in the fields of neuroscience and oncology.

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