BioMarin Pharmaceutical Inc

Associate Director, GVP Compliance BioMarin Pharmaceutical Inc

Remote — United Kingdom

Bachelor’s Degree within a life science focus area, master’s degree is a plusCONTACTSHead of R&D QualityGCP Compliance TeamGLP Compliance TeamHead of Global PV OperationsRegulatory AffairsCommercial Operations

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 StudiesAdvanced 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 studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reportingo integrated results reportingDirect experience with documentation in all phases of drug development.3) RegulatoryIntermediate 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, 4, and 5 of INDs/NDAs in eCTD formato Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)4) Project ManagementCapable of working on multiple tasks and shifting priorities.Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.Good conflict management skills.Motivated and shows initiative.Detail oriented.5) CommunicationCapable 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; intermediate to advanced presentation skills.

Deadline:26 Nov 2026

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