Principal Clinical Medical Writer
Hiring Manager: Cheryl Roberts ([email protected])
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. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
Our Culture
From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases.
SUMMARY DESCRIPTIONThe Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents. |
RESPONSIBILITIES |
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SCOPE |
This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Clinical Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. |
EDUCATION |
Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: •At least 8 years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable, e.g. European/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: · At least 8 years of experience as a medical writer in the pharmaceutical industry. Management · Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required · Demonstrated leadership abilities. · Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities. · Experience with delegating and overseeing projects and tasks. Clinical Studies · Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets. · Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. · Advanced applied knowledge of: o documentation required for the conduct of clinical studies o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) o study results reporting o integrated results reporting · Direct experience with documentation in all phases of drug development. Medical Writing · Writing high-quality documents that support corporate goals and objectives. · Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required. · Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. · Ability to interpret and create complex tabular and graphical clinical data presentations. · Ability to interpret basic clinical laboratory tests. · Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Regulatory
o ‘standalone’ regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports)
o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
Project Management
Program Management
Communication
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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.