Associate Director, Medical Writing

US-NJ-Princeton
Category
R&D Services
Travel
10%
Type
Regular Full-Time

Position Summary

The Associate Director, Medical Writing is accountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, study reports, health authority briefing books and clinical summary documents for assigned programs. In addition to authoring documents, the Associate Director, Medical Writing will be responsible for management of contributing writers on assigned programs, mainly from external sources. Ensures documents are delivered per corporate objectives, from planning through internal approval.

Responsibilities

Responsibilities and Duties:

  • Responsible for authoring TOI documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide (outside of Asia) regulatory submissions.
  • Working knowledge of publishing standards for FDA and MAA.
  • Manages Medical Writers on assigned programs, mainly via external sources including CROs.
  • Participates in the selection of external Medical Writing consultants with input from relevant function groups that are being supported.
  • Is responsible for ensuring and delivering QA/QC’d documents for assigned programs.
  • Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
  • Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
  • Responsible for management of Medical Writing budget for assigned programs.
  • Prepares project and/or status reports.
  • Owns and updates assigned Medical Writing SOPs, as necessary.
  • Some international travel will be required.

Qualifications

Educational Requirements:

  • Bachelor’s Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.

 

Experience:

  • Minimum of 8 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
  • Extensive previous experience in Medical Writing in clinical drug development, preferably some experience in oncology.
  • Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
  • Knowledge of template development, document management systems and requirements.
  • Previous experience managing Medical Writing functional areas and external CROs and consultants.
  • Substantial experience developing and implementing Medical Writing processes for all stages of clinical development (preclinical to commercial).

 

Other Skills and Abilities:

  • Excellent writing skills.
  • Strong working knowledge of Medical Writing requirements and document components. Good interpersonal skills that involves working well in a team environment and the ability to lead others.
  • Good organizational and planning skills; drive for results.
  • Ability to read, analyze and interpret scientific and technical information.
  • Effective analytical/problem solving skills.

 

Language Skills:

  • Ability to read, analyze, and interpret scientific and technical journals and legal documents.
  • Ability to respond to inquiries or complaints from regulatory agencies.
  • Ability to write procedures.
  • Ability to effectively present information to internal and external clients.

 

Mathematical Skills:

  • Ability to understand mathematical concepts such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

 

Reasoning Ability:

  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.

 

Computer Skills:

  • Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized at Taiho).

 

Physical Demands:

  • While performing the duties of this job, the employee is frequently required to sit, talk and hear.
  • The employee is occasionally required to walk.

 

Work Environment:

  • The noise level in the work environment is usually quiet.

 

 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The incumbent in this position may be required to perform other duties, as assigned.

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