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Title: Senior Medical Writer

Duration: 6 month contract, possible to renew

Pay range: $65-75/HR

Start Date: ASAP

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion.

In this role, a typical day might include the following:

+ Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided

+ Represents MW at meeting and drives document development meetings

+ Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development

+ Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict

+ May review the work of junior and outsourced MWs

+ May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion

+ Writes in plain language style as appropriate (eg, for ICF), explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience

This job might be for you if you have:

+ Strong knowledge of the clinical research process and regulations/guidelines

+ Clinical document reading, writing, and editing experience

+ Strong organizational, interpersonal and communication skills

+ Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems

+ Ability to manage multiple projects

+ Familiarity with ICH GCP guidelines

To be considered for this role, you must have

+ Bachelor's degree (advanced degree preferred) and minimum of 3 years of relevant MW experience including working knowledge of biostatistics.

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.