Associate Director, Clinical Medical Writing

2 days ago

London, United Kingdom BioMarin Pharmaceutical Inc. Full time

This job is brought to you by Jobs/Redefined, the UK's leading over-50s age inclusive jobs board.

Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science.

SUMMARY DESCRIPTION

The Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program and product development, and other resource or budgetary medical writing requirements for that/those program(s).

RESPONSIBILITIES

  • Oversight responsibilities for Medical Writing staff.
  • Works with the Head of Medical Writing to ensure appropriate CMW deliverables planning for specified clinical development program(s), including resource forecasting and allocation, timelines, and budget.
  • Acts as management-level author/reviewer for CMW and other Development Sciences deliverables, where such review/authoring is required by SOPs or other controlled process documentation.
  • Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
  • For outsourced projects, performs vendor management tasks.
  • Drafts and edits documents used in conducting and reporting the results of clinical studies.
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule.
  • Drafts and edits documents used in the preparation of regulatory filings.
  • Manages study team participation in the preparation of such documents.
  • Represents CMW at cross-functional team meetings.
  • Provides peer review and editing support for other regulatory documents.
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Oversees development and review of standard processes and templates within Clinical Medical Writing.
  • Works effectively with cross-functional groups within BioMarin.
  • Other tasks as assigned.

EDUCATION REQUIREMENTS

Masters (MS) or higher degree preferred; scientific focus desirable.

Minimum requirement: At least 10 years of experience as a medical writer in the pharmaceutical industry.

Evidence of medical writing career development desirable.

EXPERIENCE

Relevant Experience:

  • At least 10 years of experience as a medical writer in the pharmaceutical industry.
  • Minimum of 3 years administrative and/or functional management experience.
  • Demonstrated leadership abilities.
  • Experience with budgeting documentation projects.
  • Experience establishing partnerships with cross-functional groups in a clinical development setting.
  • Experience with delegating and overseeing projects and tasks.
  • Experience coaching or mentoring medical writers.

Computer/Office Equipment Skills

  • Proficiency in Microsoft Word, Excel, Adobe Acrobat, and PowerPoint.
  • Proficiency with MS Project/Project Server.
  • Experience using document management software.

Regulatory

  • Ability to plan and manage development of regulatory documents.
  • Support project teams by identifying and summarizing relevant regulations and guidelines.

Project Management

  • Ability to plan, resource, assign, and keep executive management appraised of the status of multiple simultaneous document development projects.

Communication

  • Capable of well-organized, concise and clear written and verbal communication.
  • Effective at explaining writing principles to a varied audience.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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