Sr. Medical Writer

Job description

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.

Base pay range

$70.00/hr - $80.00/hr

Sr. Medical Writer

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.

Primary Responsibilities/Accountabilities

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

Qualifications

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

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

Integrated results reporting

Direct experience with documentation in all phases of drug development

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)

Computer/office equipment 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

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: Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format

Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISS)

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

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

If this job is a match for your background, we would be honoured to receive your application! Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Other

Industries: IT Services and IT Consulting

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Worksite address

california, MO, 65018, US

Who can apply

Review the original listing for work authorization, qualifications and employer requirements.