Senior Medical Writer

About this role

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 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.
ROLE:
The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
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 safety reports (PBRERs, DSURs, etc.)

• Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD 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 Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).

• Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.

• Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials

• Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments

• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.

• 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 Global 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.

EXPERIENCE:

• Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility.
1) Medical Writing:

• Experience writing, reviewing, or editing protocols and clinical study reports required.

• Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.

• Experience writing, reviewing, or editing regulatory briefing books preferred.

• 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.

• Advanced applied knowledge of basic clinical laboratory tests.

• Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

• 2) 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.

• Intermediate to 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.

• 3) Regulatory

• Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

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

o Modules 2, 3,…