Job description

STATKING Clinical Services (SCS), a member of Genesis Biotechnology Group, a full-service contract research organization (CRO) for the pharmaceutical and medical device industries located in Fairfield, OH, is seeking a Medical Writer to perform medical writing and other duties related to the pharmaceutical and medical device development programs, as well as other tasks related to clinical operations.

• SCS is seeking a medical writer to be responsible for working with the statistical group writing the following: clinical study reports, protocols, investigator brochures and submission documents. You will also be involved with other parts of the product development process including study design, labeling, risk analyses, drug formulation and drug method of action.

Essential Functions:

• Writing submission documents and performing tasks that relate to submission activities
• Writing clinical study reports, publications, and other clinical documents
• Other clinical operations tasks as necessary
• The following characteristics would be a plus in considering applicants:
• Previous experience in the CRO industry
• Clinical Trial Management and Project Management Experience
• Previous experience as a pharmacist or related activity
• Understanding of clinical trials and CTMS platforms.
• Job Qualifications: General K*nowledge, Skills, and A*bilities (KSA’s) required
• A Doctorate in Pharmacy or 3-4 years clinical trial experience as a Medical Writer
• Excellent oral and written communication skills
• Excellent organizational skills
• Technical proficiency in Microsoft Word, Acrobat, and other software used to prepare documents for submission to the FDA
• Previous industry sponsored clinical trial experience and regulatory submission experience
• Demonstrated excellent oral, written and presentation communication skills
• Excellent communication skills (both written and oral) and the ability to build effective relationships with trial center staff and colleagues.
• An eye for detail.
• Ability to multi-task and think on your feet.
• Good organizational, IT and administrative skills – job involves lot of documentation and recording of information through computerized processes.

We Offer:

• Competitive salary.
• 401k
• Benefits including dental and vision.
• Health Savings Account.

Job Types: Full-time, Part-time

Benefits:

• Flexible schedule
• Health insurance
• Life insurance
• Paid time off

Schedule:

• 10 hour shift
• 8 hour shift

Ability to commute/relocate:

• Burr Ridge, IL 60527: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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