DescriptionROLE: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, 4, and 5 of INDs/NDAs in eCTD format
o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
- 4) Project Management
- 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.
- 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) 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; intermediate to advanced presentation skills.
EDUCATION:- Bachelor's or higher degree required; scientific focus desirable.
- 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.
COMPUTER SKILLS:- Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
- Experience using document management software (eg, LiveLink, SharePoint, Veeva)
- Experienced with scanners, printers, and copiers.
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.
