Published
June 24, 2020
Location
Remote, United States of America
Job Type
Work Setting
Remote / Home-based

Description

BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

Overview

 

Global Medical Affairs (GMAF) is an expert scientific and medical function that develops and maintains non-promotional, evidence-based, transparent and balanced scientific and educational programs and resources in support of BioMarin’s products and disease states of interest.  We do this by assuring safe and appropriate product use, supporting continuous scientific exchange and through ongoing and new data generation.

 

The Medical Communications group is responsible for leading clinical and scientific data dissemination efforts across BioMarin Medical Affairs.  Medical Affairs communications are a critical element in the dissemination of scientific and clinical data to broad audiences including healthcare providers, enabling them to provide the best possible care to their patients.  As a program lead, the Medical Communications Associate Director / Director develops publication strategies and plans based on scientific knowledge gaps, and scientific messaging platforms based on cross-functional needs.  The effective Medical Communications Associate Director / Director will perform in-depth statistical analyses, facilitate systematic literature analyses, and manage a team medical writers and/or graphic designers to deliver best-in-class messaging, abstracts, posters, oral presentations, and manuscripts.

 

Summary

 

The Associate Director / Director is an emerging leadership position in Medical Communications with substantial strategic input across Global Medical Affairs for assigned product(s) or therapeutic area(s). The Associate Director / Director will focus on shaping and defining scientific message platforms and related publication plans for assigned products, including synthesizing stakeholder input, ensuring alignment cross-functionally, and conducting gap analyses for defining the publication strategy.  The Associate Director / Director will also lead content creation activities including oversight of authors and ensure compliance with all BioMarin publication processes. This position may also oversee the advancement and implementation of end-to-end publication process including publication management systems and tools, and training of end users.  This position may be responsible for supporting Medical Communications functional leadership activities including managing staff, budgets, and departmental activities.

 

Responsibilities

 

Scientific Messaging Development

  • Identify key literature and high-impact resources from which scientific messages can be derived
  • Build/manage scientific messaging database to support cross-functional messaging needs
  • Monitor relevant literature on an ongoing basis to update existing messages or develop new messages
  • Review cross-departmental materials to ensure alignment with scientific messaging database
  • Collaborate with cross-functional stakeholders to identify novel messaging needs/gaps; ensure identified gaps are represented in strategic publication plan

 

Publication Strategy and Planning

  • Lead regular publication planning meetings to ensure organizational alignment on timelines, strategies, and gaps
  • Analyze current messaging database and published literature to identify gaps in scientific knowledgebase; ensure identified gaps are represented in strategic publication plan
  • Collaborate with BioMarin stakeholders to facilitate the development of publication concepts that address identified gaps
  • Oversee planning and development of manuscripts with foci on scientific research, clinical study outcomes, health economic and outcomes research, value and access issues, stakeholder education, and more
  • Provide global Medical Communication support to the expanding scope of Worldwide Research and Development activities

 

Publication Content Creation

  • Research, draft, and edit scientific and medical manuscripts, abstracts, posters, and presentations; incorporate author and reviewer comments
  • Manage agency and/or contract medical writers and/or statistical programmers, as needed
  • Oversee required graphic design for publications
  • Ensure all medical communications outputs meet the highest standards of medical/scientific integrity
  • Ensure appropriate adherence to authorship and publication guidelines as stipulated by BioMarin operating procedures, ICMJE, and GPP3
  • Work closely with biometrics, clinical science, research, and other colleagues to ensure timely collation, interpretation, and reporting of data to support publication plans; perform or facilitate data reviews as needed

 

Publication Process, Systems, & Reporting

  • Oversee the strategic consideration and appropriate internal review of new abstract/publication concepts; ensure compliance with all documentation steps
  • Oversee the daily maintenance of all publication records in Publication Management system; perform periodic audits to determine completeness of records and level of compliance with industry guidance; use the results to identify potential areas for process improvement
  • Ensure all published works are recorded, disseminated internally, and used to derive new scientific messages
  • Represent all publications in development and key forums for review and approval; maintain compliance with BioMarin publication processes and guidelines
  • Maintain and optimize publication management systems, including keeping user, drug, research, and study information up to date; maintaining workflow and email templates; managing built-in filtering and reporting capabilities; and monitoring integration with the internal publication review and approval systems
  • Manage the Medical Communications internal webpages including informational content, usage reporting, file structures, and permissions
  • Support preparation of Sunshine Act reports through compliant and consistent documentation practices

 

Publishing

  • Execute publication graphic design of figures and tables in Microsoft and Adobe, including incorporation of subsequent change requests
  • Compile materials required for electronic abstract and manuscript submissions
  • Copyedit manuscripts, abstracts, posters, and presentations for grammar, spelling, layout, data accuracy, correct citations, and alignment with pre-specified formats and industry standards
  • Arrange for payment of Open Access and other publication-related fees

 

 

Congress / Convention Management

  • Lead regular planning meetings to ensure organizational alignment on congress submission timelines, strategies, and gaps
  • Work closely with biometrics, clinical science, research, and other colleagues to ensure timely collation, interpretation, and reporting of data to support congress activities
  • Develop and maintain yearly congress calendars
  • Manage all aspects of scientific poster or presentation development
  • Support identification and confirmation of presenting authors, as needed
  • Contribute and implement ideas for improving poster development process
  • Develop tracking spreadsheet for each congress
  • Manage printing/shipping logistics for posters; presentation formatting and transfer logistics for presentations
  • Develop Congress Cards as needed to provide dates, times, and locations of posters and presentations

Functional Leadership

  • Serve as the Publication lead to the Research and Early Development function and Gene Therapy Franchises and oversee the other Medical Communications employees supporting this franchise
  • Respond to internal and external questions about any publications for product area
  • Participate in cross-functional team meetings to share publication planning status and issues and maintain awareness of overall product publication plan
  • Lead and/or contribute to functional improvement initiatives for the MSL team
  • Oversee the development and maintenance of Medical Communications work instructions
  • Provide support for management of the Medical Communications budget, including maintenance of the day-in, day-out accounting.

 

Education & Experience

 

  • BA/BS in life or health sciences; Advanced degree (MS or doctoral) preferred
  • 10 or more years of relevant experience in medical communications, publication planning and/or medical writing
  • 5 or more years managing a team of direct reports

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

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