Associate Director, Regulatory Medical Writing, Global Medical Affairs

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 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 help fulfill post-marketing commitments to ensure ongoing patient access to our therapies. The medical writer applies documentation preparation and project management skills to assist in the development, drafting, reviewing, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

Summary

The Associate Director supports the Medical Communications regulatory writing function in alignment with the requirements of GMAF and organizational goals. This is an emerging leadership position in Medical Communications with substantial strategic input across GMAF for assigned product(s) or therapeutic area(s). The Associate Director will focus on shaping and defining medical writing activities for assigned products, including synthesizing stakeholder input, ensuring alignment cross-functionally, and conducting gap analyses for defining the writing strategy. The Associate Director will also lead content creation activities including oversight of contract writers and ensure compliance with all BioMarin standard operation procedures. This position may be responsible for supporting Medical Communications functional leadership activities including managing staff, budgets, and departmental activities.

Responsibilities

• Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
• Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic study reports
• Drafts and edits clinical summary documents (Modules 2.5 and 2.7) used in NDA/BLA filings that conform to ICH CTD structure
• Provides peer review and editing support for other regulatory documents such as response documents and briefing packages
• Manages study team participation in the preparation of such documents, including calling/running meetings and managing the document review and comment adjudication processes
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work
• Participates in providing oversight of external medical writing vendors and 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
• Supports Medical Communications group 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

Education & Experience

• BA/BS in life or health sciences; advanced degree (MS or doctoral) preferred
• 5 or more years of experience as a medical writer in the pharmaceutical industry
• 8 or more years of medical or scientific writing experience as a primary job responsibility
• Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association