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Director, Medical Communications

Location San Rafael, California
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.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY 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.

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, support of continuous scientific exchange and through ongoing and new data generation.

 The Medical Communications group is responsible for leading the scientific publication and regulatory document development efforts across GMAF.  The scientific publications are critical elements in the collection and dissemination of scientific and clinical data to healthcare providers, enabling them to provide the best possible care to their patients, while the regulatory documents are essential to help fulfill BioMarin’s post-marketing commitments to ensure ongoing patient access to our therapies.  The Regulatory Medical Writing Lead oversees  documentation preparation and utilizes project management skills for the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

RESPONSIBILITIES

  • Oversees the drafting and editing of documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports globally
  • Oversees the drafting and editing of documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures, periodic regulatory reports, and periodic safety reports (PBRERs, DSURs, etc.)
  • Manages study team and regulatory medical writing vendor participation in the preparation of such documents, including calling/running meetings and managing the document review and comment adjudication processes
  • Provides peer review and editing support for all regulatory documents, as well as other documents including the statistical analysis plans, and other study materials
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
  • Provides oversight of external medical writing vendors and statistical programmers contributing to the development of documents
  • Works effectively in a highly cross-functional environment. Establishes and maintains effective cross-functional communication, including with key Study Management, Clinical, Commercial, and Regulatory counterparts and stakeholders.
  • Establishes relationships with healthcare professionals/authors/investigators
  • Assists Directors of Medical Communications and Study Management in the  management of departmental workflow and deliverables
  • Assists Director of Medical Communications to forecast and secure resources for document development
  • Other tasks as assigned

SCOPE

This position supports the Medical Communications’ global regulatory writing function in alignment with the requirements of Global Medical Affairs and organizational goals.

EDUCATION

Masters or higher degree preferred; scientific focus desirable.

Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing and regulatory writing.

Evidence of regulatory medical writing career development desirable, i.e., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

EXPERIENCE

Relevant Experience

Fulfills one of the following:

·       Up to 2 years of as a regulatory medical writer in the pharmaceutical industry

·       At least 5 years of medical or scientific writing experience as a primary job responsibility with familiarity of regulatory writing requirements

Clinical Studies

·       Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.

·       Familiar with clinical study data collection and results reporting.

Medical Writing

·       Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.

·       Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.

·       Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.

·       Ability to interpret basic tabular and graphical clinical data presentations.

·       Ability to create basic tables using AMA style (eg, Schedule of Events).

·       Intermediate applied knowledge of basic clinical laboratory tests.

·       Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

·       Basic understanding of biostatistical and clinical research concepts.

Computer/Office Equipment Skills

  • Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
  • Experienced with scanners, printers, and copiers.

Regulatory

  • Intermediary to advanced knowledge of regulatory requirements and guidance associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

Project Management

  • Capable of working on multiple tasks and shifting priorities.
  • Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
  • Good conflict management skills.
  • Motivated and shows initiative.
  • Detail-oriented.

Communication

  • Capable of well organized, concise and clear written and verbal communication.
  • Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
  • Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.


SUPERVISOR RESPONSIBILITY

 Will oversee internal and external medical writers and consultants.  

CONTACTS

Internal: Clinical Operations, Study Management, Market Access, Commercial / Pipeline Commercialization, Commercial Marketing, Communications, Regulatory Affairs, Regulatory Patient Engagement, Medical Information, Legal / Compliance, Corporate Communications, Pharmacovigilance, Biometrics, DSQ, Business Operations

External:  Vendors, Study Sites, Key Opinion Leaders, Health Care Practitioners, Advisory Boards

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San Rafael

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