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4 days old

Trial Disclosure Medical Writer

Kelly Services
North Chicago, IL 60064
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Trial Disclosure Medical Writer** at a prestigious Fortune 500 company working in **North Chicago, IL.**





**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Trial Disclosure Medical Writer**


**Pay Rate: $34.75 per hour**




Candidate will start remote during pandemic, but must be able to work onsite after pandemic (possibly 100% onsite)


**Responsibilities** :

Assist the Trial Disclosure (TD) area with the execution of clinical drug trial registration per the applicable regulatory and SOP requirements.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of TD: to determine drug trials required to be registered, to effectively communicate this information and related timelines to the applicable individuals involved in these activities, to provide guidance to and build cross-functional collaborative relationships, to coordinate the completion of these activities to achieve/ensure timely disclosure of accurate and complete information (including populating each Protocol Record with disclosure information on ClinicalTrials.gov (CT.gov).

Work closely with/support the Project Manager(s) and Sr. Clinical Trial Disclosure Associate(s) of TD in operationalizing changes in both the US and International regulatory environment via participation in the implementation of SOPs/processes as well as creating efficiency improvements/further system automation and related communication and training activities.

Participate in TD compliance prevention by providing QC checks and metrics as requested.

Maintain/track TD for clinical drug trials, including the documentation and storage of the information.

Cross-train with other TD staff.

Accountable for meeting the main objectives of assigned projects/roles and responsibilities within established timelines and with an appropriate quality level.

Accountable to Associate Director of TD. Act as a key contributor, who exhibits a moderate level of technical competencies and requires a low level of counsel and guidance.

Daily interaction with TD Project Manager(s) and/or Sr. Clinical Trial Disclosure Associate(s) of TD as well as significant interface/communication with cross-functional areas.

Expedient escalation of issues to management is essential and may have a direct impact on TD compliance.


**Qualifications** :

Bachelor's degree (BA/BS), from an accredited college or university is required, preferably in a health or biological science field.

Must have 2+ years of clinical research experience or experience in a related area such as quality or regulatory and working knowledge of drug development.

Must be familiar with ICH and GCP Guidelines and have good organizational and communication skills and competent in application of standard business procedures (SOPs/Work Instructions, OEC).

Must have the ability to prioritize roles and responsibilities daily and work well under deadline pressure in a team environment in order to execute goals to ensure they are achieved (i.e. maximize individual skills utilizing the collective skills of the CTD area).


Top skills required:



Project Management

Writing

Knowledge of drug development lifecycle and familiarity with clinical documents

Demonstrated ability to manage timelines and execute to due date

Excellent organizational skills, attention to detail, and strong oral and written communications skills






**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**








**Why Kelly** **** **?**



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**About Kelly** ****



At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-20 Expires: 2020-12-21

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Trial Disclosure Medical Writer

Kelly Services
North Chicago, IL 60064

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