Director / Sr, Medical & Scientific Writing

11 - 15 years experience  • 

Salary depends on experience
Posted on 03/21/18
11 - 15 years experience
Salary depends on experience
Posted on 03/21/18

Description

The Head of Medical and Scientific Writing (HMSW) is responsible for the creation of documents pertaining to clinical and safety data to support scientific product development and license applications on behalf of, and in conjunction with, corresponding project teams. The head writer leads the writing activities (clinical/non-clinical/regulatory) and manages resources assigned to clinical, nonclinical, and regulatory documents according to applicable regulations and internal guidelines. The HMSW may assist in authorship of abstracts, posters and manuscripts, and patient education materials. In addition, the head medical writer represents the Medical Writing function for the business and works closely with the clinical, safety and regulatory science departments to ensure content is appropriate and within guidelines. Finally, the medical writing leader will lead, develop and mentor team members, as well as external resources, to ensure a cohesive and productive group and function.

What you'll dive into

  • Partners with the clinical team and key stakeholder to plan for the writing of protocols, study reports, consent forms and investigator brochures
  • Partners with the regulatory team to prepare other regulatory documents such as health authority meeting briefing packages, CTD summaries and overviews, annual reports, and other documents required for submission
  • Leads a team of internal/external (contractors/vendors) authors as needed
  • Provides project teams with expertise on regulatory requirements and corporate procedures and standards controlling documents for regulatory submission.
  • Provides project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
  • Provides oversight of documents quality and consistency; ensures efficient formatting of documents as well as consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier or briefing package
  • Contributes to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Identifies and participates in development and improvement of key business processes, best practices, and tools and templates related to medical and regulatory writing as required
  • Ensures assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams, leadership and key stakeholders in a timely manner of any deviations or potential deviations
  • Positions and maintains the medical writing function as a strategic partner to the other development functions throughout the lifecycle of a project
  • Tracks progress against targets; produces timely and accurate status updatereports

What we expect

  • Bachelor’sdegree in a related fieldrequired; Advanceddegree (e.g., MBA, PhD) ispreferredAdvanced experience using Microsoft Office Suite including Project, Excel, Power Point and SharePoint
    • BS/BA plus 15years of relevant and progressive experience; or
    • MS/MA plus 12years of relevant and progressive experience; or
    • PhD plus 9+ years of relevant and progressive experience required
  • Recent and significant experience in writing regulatory documents such as Clinical Study Reports, Protocols, Summaries and Overviews
  • Experience with EDMS administration, publishing software, and writing tools (e.g. ISI Writer) is preferred
  • Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses.
  • Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area; Significant familiarity with medical terminology
  • Demonstrated ability to interpret complex analyses of data supporting regulatory submissions
  • Demonstrated ability to think strategically while being hands on
  • Demonstrated ability to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
  • Detail-oriented with effective problem-solving and troubleshooting skills
  • Excellent communication skills (verbal/written/presentation) 
  • Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies
  • Passion for science

What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives
  • Opportunities to learn and contribute creative solutions
  • Comprehensive health insurance ($0 premium on select medical plans)
  • Matching 401k retirement plan
  • Paid time off and holidays including a Summer & Winter break
  • Company celebrations.
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