Job Description
Job Title: Senior Medical Writer
Location: San Rafael, CA - hybrid
Type: Contract
Compensation: $65.00 - $71.92 hourly
Job Description: The Contract 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 for submissions including CTDs and RtQs
- 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 (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
- Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
- Works effectively with cross-functional groups within COMPANY
- Other tasks as assigned.
Skill and Experience: - At least 6+ years experience required
- Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
- Familiar with clinical study data collection and results reporting. ? Previous protocol development experience required.
- Experience writing, reviewing, or editing protocols and clinical study reports highly preferred.
- Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
- 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 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).
- Basic understanding of biostatistical and clinical research concepts.
- Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
- Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
EDUCATION - Bachelor's or higher degree; scientific focus desirable.
- Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
Benefits System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
Job Tags
Hourly pay, Contract work, Work alone,