Principal Clinical Medical Writer

Location: San Rafael, California Category: Clinical

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 DESCRIPTION

The 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

Oversight responsibilities for Medical Writing staff
Works with the Head of Medical Writing to establish and maintain timelines for program planning.
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 safety reports (e.g. PBRERs, DSURs)
Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.

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

Proficient in Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
Experience using document management software (e.g. SharePoint, Veeva)
Experienced with scanners, printers, and copiers.

Regulatory

Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs:

o ‘standalone’ regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports)

Prior familiarity with standard eCTD IND/NDA work, including:

o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format

o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)

Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances.

Project Management

Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities.
Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions
Ability to support staff in renegotiating timelines during development as necessary.

Program Management

Capable of managing and maintaining multiple timelines governing multiple projects within a program.
Capable of performing resource assessments (short- and long-term) based on projected project needs within a program.
Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions.

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.

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.

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