Principal Clinical Medical Writer

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United States

BioMarin Pharmaceutical

Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D 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 rare diseases. 

SUMMARY DESCRIPTION:

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. 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.

  EXPERIENCE:

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:

Documentation required for the conduct of clinical studies

Protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)

Study results reporting

Integrated results reporting

Management Experience:

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.

 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).

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:

Standalone’ regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports)

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

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

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.

  EDUCATION:

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

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

WORKSTYLE:

Role may be conducted remotely unless you live within 100 miles of our Headquarters in San Rafael, California or 2nd site in Novato, California.  If you do then role reverts to hybrid requiring an onsite presence 2x weekly.

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.

Ireland Safety Responsibility

Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

The salary range for this position is: $171,720 to $236,115. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it’s from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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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.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email  Applicant_accommodations@bmrn.com  with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team – please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at  talentacquisition@bmrn.com .

Applicants, please do not use this email address to submit resumes – if you do so, you will be redirected to apply through the website.

Click here to review “EEO Is The Law” poster .  Click here to review the Pay Transparency Nondiscrimination Statement .  Click here to review the Notification of Employee Rights under Federal Labor Laws .

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