Sr. Medical Writer

Pay Range

This range is provided by TALENT Software Services. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$70.00/hr - $80.00/hr

Job Summary:

Talent Software Services is in search of a Sr. Medical Writer for a contract position in CA (Remote). The opportunity will be six months with a strong chance for a long-term extension.

Position Summary:

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 Client 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.

• 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 Client's
• Other tasks as assigned

• Bachelor's or higher degree required; scientific focus desirable
• Minimum requirement:
  Experience in medical writing
• Evidence of medical writing career development desirable, e.g., American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association

Fulfills one of the following:

• Up to 6 years as a medical writer in the pharmaceutical industry
• At least 10 years of medical or scientific writing experience as a primary job responsibility
• 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

• 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
• Integrated results reporting
• Direct experience with documentation in all phases of drug development

• 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…