Principal Medical Writer
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
The Principal Medical Writer applies intermediate to 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.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms.
- Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (eg. PSURs, DSURs).
- 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.
- 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.
This position aids the full-time medical writing staff as needed for the requirements of the Development Sciences department and organizational goals. Filling this need will enable BioMarin to increase Clinical Medical Writing productivity to meet development needs.
Bachelor’s or higher degree preferred; scientific focus desirable.
- Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
- Evidence of medical writing career development desirable, eg, European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
Good experience in medical writing in the pharmaceutical industry.
- Good understanding of the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
- Good understanding of clinical study data collection and results reporting.
- Previous protocol development experience required.Medical Writing
- Experience writing, reviewing, or editing protocols and clinical study reports.
- Experience writing, reviewing, or editing INDs and BLA/NDAs.
- Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
- Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
- Ability to interpret tabular and graphical clinical data presentations.
- Ability to create tables using AMA style (eg, Schedule of Events).
- Intermediate applied knowledge of clinical laboratory tests.
- Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
- Understanding of biostatistical and clinical research concepts.Computer/office equipment Skills
- Proficient in Microsoft Word (including the use of templates), MS Project, Excel, and PowerPoint.
- Experienced with scanners, printers, and copiers.
- Knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
- Ability to develop Module 2s of INDs/NDAs in the eCTD format, EU Risk Management Plans, aggregate safety updates (e.g. PSURs, DSURs) and responses to EMA queries.
- Capable 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.
- Good conflict management skills.
- Motivated and shows initiative.
- Detail oriented.
- 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.
- Good presentation skills.
Clinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance.
Access to corporate computer network, production computing environment, and MS Windows software.
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.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.