Medical Writer Clinical I (MWC01)
Job Title: Medical Writer Clinical I
Candidate will start remote during pandemic, but must be able to work onsite after pandemic (possibly 100% onsite)
• 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 the 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.
• 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 utlizing the collective skills of the CTD area).
What are the top 3-5 skills requirements should this person have?
• Project Management
• 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
What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
Examples: Bachelor of Science; 4 year pharma, health care, or regulated industry
2+ years of clinical research experience; Bachelor’s degree (preferably in Health, Biological Sciences or English)
What type of environment is this person working in?
o Group setting
o Individual Setting
o Combination of both
Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?
8 hours per day, core hours central 9 to 4, half hour or hour for lunch
What is the length of the desired contract? 6 months (with possibility to extend)
Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?: On-site only
Is the worker onshore or offshore? (If offshore confirm with manager that the worker will align to a USD Cost Center for invoicing purposes.) If no, escalate to Operations Manager onshore: Onshore
Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling: No travel expected.