Associate Director, Clinical Medical Writing

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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 Associate Director of Clinical Medical Writing has administrative and functional oversight responsibilities for Medical Writing staff, including authoring/editing documents. The Associate Director may participate in review and approval of regulatory submission documents and publications, and will work with the Head of CMW in departmental resource planning, submission planning for program and product development, and other resource or budgetary medical writing requirements for that/those program(s)

RESPONSIBILITIES

• Oversight responsibilities for Medical Writing staff
• Works with the Head of Medical Writing to ensure appropriate CMW deliverables planning for specified clinical development program(s), including resource forecasting and allocation, timelines, and budget
• Works with CMW line management to establish and maintain timelines for program planning.
• Acts as management-level author/reviewer for CMW and other Development Sciences deliverables, where such review/authoring is required by SOPs or other controlled process documentation
• Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
• For outsourced projects, performs vendor management tasks (including but not limited to reviewing contract proposals, conducting interviews, preparing and conducting onboarding sessions, and providing oversight for external writers)
• 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. PSURs, 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 calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
• Represents CMW at cross-functional team meetings (eg, 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.
• Oversees development and review of 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 REQUIREMENTS

Masters (MS) or higher degree preferred; scientific focus desirable.

Minimum requirement: At least 10-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

State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

Relevant Experience

Fulfills one of the following:

At least 10 years of experience as a medical writer in the pharmaceutical industry

Management

• Minimum of 3 years administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting.

• Demonstrated leadership abilities.

• Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities.

• Experience with budgeting documentation projects.

• Experience selecting vendors, establishing working relationships with vendors, and overseeing vendor deliverables.

• Experience establishing partnerships with cross-functional groups in a clinical development setting.

• Experience with delegating and overseeing projects and tasks.

• Experience with establishing departmental and company-level processes and procedures.

• Experience coaching or mentoring medical writers both in behavioral and technical areas.

Clinical Studies

- Able to mentor or train others in clinical study concepts, design, and documentation

- 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.

- Ability to mentor, train, or manage others in the following:

o Routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.

o Interpreting data from tables, graphs, and listings

o Creating in-text data presentations (including complex tabular and graphical clinical data presentations)

o Interpreting basic clinical laboratory tests

o Researching literature

o Understanding concepts of coding dictionaries (MedDRA, WHO Drug)

o Preparing high-quality clinical and regulatory documents (protocols, IBs, clinical study reports, ICFs).

Computer/office equipment Skills

• Proficiency and ability to train/mentor others in the use of Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, and PowerPoint.
• Proficiency with MS Project/Project Server
• 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 (e.g. protocols, investigator brochures, clinical study reports, IND annual reports)

o Clinical sections of pre-submission meeting packages (e.g. pre-IND or end-of-Phase 2 meetings), Orphan Drug Applications, CTAs, IMPDs, etc.

o Targeted Product Profile, Package Inserts/Product Labels (using structured product labeling guidelines)

o Responses to FDA queries and inspection findings

• Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US, EU and RoW submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances.
• Ability to provide leadership for presentations to regulatory authorities and regulatory inspections.

Project Management

• Ability to plan, resource, assign, and keep executive management appraised of the status of multiple simultaneous document development projects (stand-alone and complex dossiers) with shifting priorities
• Ability to support staff in renegotiating timelines during development as necessary.
• Good conflict management skills.

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.