Senior Medical Writer/Associate Director, Medical Communications 

Are you an experienced medical writer with a passion for technical reports that include a variety of statistical analyses?

Location: Tucson, AZ, Chicago IL, or Folkestone, UK

Remote working is available.

We are committed to continuous, dedicated support across all facets of clinical outcomes research to assist with value driven decisions for informing patient care. With a specific focus on clinical outcome assessments (COAs), we are specialized in measuring and understanding patient-reported outcomes, clinician-reported outcomes, observer outcomes, and screening tools in the context of specific clinical conditions.

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Benefits

Meet the team

We have a global team covering all aspects of clinical research.
You can meet the team here

Senior Medical Writer/Associate Director, Medical Communications 

Duties

Work independently and directly with the Medical Communications team to gather, organize, and compile qualitative and quantitative information from COS research studies to support the development of scientific reports (with a specific focus on statistical technical reports), abstracts/posters, slide decks, manuscripts, and dossiers for internal and external presentation of outcomes research. This role offers the opportunity to work locally and globally on patient centered research studies across multiple therapeutic areas.

Skills:

• Prepares, edits, and finalizes clinical study reports, regulatory documents, and COS-scientific communications such as abstracts, posters, presentations, and manuscripts
• Works with the internal qualitative and quantitative study teams on the development of reports and scientific communications (primary focus with the quantitative study team)
• Reviews and comprehends blinded data tables, listings, and figures for report writing
• Applies medial content development knowledge, COA knowledge, and skills to deliver quality research for assigned projects
• Collaborates with the COS research teams to ensure that the results contained within reports reflect the data derived within each study; ensuring high quality and accurate results
• Manages the document quality review process to internal quality control (QC) standards as outlined in COS Standard Operating Procedures
• Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timelines
• Assist in the production and (possibly) graphical presentation of statistical and qualitative information
• Experience in conducting literature reviews
• A keen eye for detail (in relation to both scientific content and editorial standards)
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) with expertise with AMA Manual of Style
• Desire to work on a small team in a fast-paced client focused environment
• Excellent oral and written communication skills
• Good interpersonal skills
• Strong process and project management skills
• Desire to have good work life balance (work hard and enjoy life outside of the work walls)

Education:

• A minimum of Bachelor's degree in psychology, health psychology, biological or life science, or related areas is required (Master’s preferred for Senior Medical Writer and PhD preferred for Associate Director)
• A good understanding of the medical content development, COA discipline and pharmaceutical drug development process is required; an understanding of the regulatory environment is preferred
• At least five years as a full-time medical writer for the Senior Medical Writer role and nine years as a full-time medical writer for the Associate Director role required (relevant statistical technical COA writing experience is also required)

Levels: 

• COS offers various levels within this position commensurate with qualifications and experience.

COS celebrates diversity and inclusion.  As such, we strive to bring passionate individuals together from diverse backgrounds to pursue our mission and vision.