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Reference #: R14924 Clario is a 50+ year old company that delivers industry leading clinical trial endpoint technology solutions. The future of clinical trials is vibrant, with new technologies revolutionizing what's possible. From new trial modes to faster and integrated evidence and findings, our innovative clinical trial solutions mean we can unlock better evidence.

What we offer:

Competitive compensation

Medical, dental, and vision insurance beginning Day 1 of employment

Flexible work schedules

Attractive PTO plan

Engaging employee programs

Remote working

Primary Responsibilities Performs read-related document responsibilities by: Performing a concise and thorough review of study Protocols related to response criteria requirements, tumor assessments, inclusion/exclusion criteria, imaging-related objectives and endpoints, concomitant procedures, indication specific-requirements, etc. Performing a concise and thorough review of study-specific electronic Case Report Forms (eCRFs/CRFs). Creating, developing, modifying and finalizing Charters (i.e., full Charters, 2-scenario Charters, Procedures Documents, and/or Process Documents). Creating, modifying and finalizing Clinical Data Transfer Plans (CDTPs). Creating, modifying and finalizing the Reader Training Package (RTP, consisting of the Charter Training Slides [CTS] and quiz for each review type and/or criteria). Creating, modifying and finalizing Read Ready-related Compliance Reports (CRs) such as Notes to File (NTFs), Corrections, Transfer of Obligations (ToOs) and non-Quality Event Deviation Reports Reviewing and modifying criteria-related Investigator Meeting slides, as applicable. Attending internal and external meetings relating to study documents such as the Charter, CDTP, CRs, or RTP. Supervising the Associate Medical Writer in the creation, updating, modification and maintenance of the MedComm web pages for ease of access by IO, CPM, MA and any other departments who use the web pages. Reviewing, modifying and developing Standard Operating Procedures(SOPs)/Work Instructions pertinent to Medical Communications (and Medical Affairs, as applicable). Updating MW training modules, as required. Reviewing applicable study start-up documents (i.e., Manuals and forms, study start-up CRs) for accuracy, completion and consistency across all study documents. In addition, a Read-Ready Writer may assume any responsibilities of a Study Start-Up writer (Associate Medical Writer), as needed. Manages the clinical study document development process by: Creating, modifying, finalizing and attaching signed final CRs to Final MedComm documents or reviewing Project Team-created CRs Updating, modifying and maintaining the MedComm database and applicable document tracking spreadsheets to track document progress and study details Providing guidance to assigned Project Teams and Project Team members Providing language updates, as required, for all MedComm document templates as needed Creating Final Effective documents

Secondary Responsibilities Maintains quality service and departmental standards by: Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP") Updating department SOPs and Work Instructions as needed Assisting in establishing and enforcing departmental standards Contributes to team effort by: Working with internal staff to resolve issues Exploring new opportunities to add value to organization and departmental processes Participating in internal training activities Helping others to achieve results Performing other duties as assigned Maintains Technical and Industry Knowledge by: Staying up-to-date on response criteria publications posted by Medical Communications Participating in Medical Writing Training activities, including creating/reviewing training modules Attending and participating in applicable company-sponsored training

Qualifications Education: Bachelor's Degree in eith r the Life or Physical Sciences (e.g., Biology, Chemistry, Physics, Pharmaceutics, etc.) preferred Experience: 2+ years medical writing experience preferred 3+ years' experience in pharmaceutical/clinical/imaging research required Demonstrated proficiency in medical, pharmaceutical, regulatory, clinical writing Proficiency in MS Office Suite (Word, Excel, Outlook, PowerPoint, Access) Understanding and knowledge of medical and/or clinical trial terminology desired

Additional Skill Set: Ability to work in a group setting and independently; ability to adjust to changing priorities Excellent attention to detail and orientation toward meticulous work Strong interpersonal and communication skills, both verbal and written Strong documentation and organizational skills Ability to project and maintain a professional and positive attitude Organization and time management skills for managing multiple projects concurrently

Working Conditions Travel: 0-5% Lifting: 0-10lbs Other: Computer work for long periods of time

This JOB description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.

EEO Statement Clario is an equal opportunity employer. Clario evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status, or any other legally protected characteristic.

ERT is an equal opportunity employer and all qualified applicants receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.