Medical Writer 2 - UK, also open in the USLocation London, United Kingdom Apply
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.
The Clinical Medical Writer 2 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, 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 (PSURs, DSURs, etc.)
- 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
- 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
- Works effectively with cross-functional groups within BioMarin
- Other tasks as assigned.
Education & Experience
- Bachelor’s or higher degree required; 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, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
Fulfills one of the following:
- Up to 4 years of as a medical writer in the pharmaceutical industry
- At least 7 years of medical or scientific writing experience as a primary job responsibility
- Intermediate to advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, and clinical study data collection.
- Basic understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
- Intermediate to 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
- Familiarity with documentation in all phases of drug development.
- Writing high-quality documents that support corporate goals and objectives.
- Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
- Experience writing, reviewing, or editing INDs and BLA/NDAs preferred.
- Intermediate to 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 basic tabular and graphical clinical data presentations.
- Ability to create basic tables using AMA style (eg, Schedule of Events).
- Intermediate applied knowledge of basic clinical laboratory tests.
- Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
Computer/office equipment Skills
- Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
- Experience using document management software (eg, LiveLink, SharePoint, Veeva)
- Experienced with scanners, printers, and copiers.
- Basic knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
- 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; basic presentation skills.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.