Nashville, TN | Contract
Zycron has a great opportunity for a Medical Writer with our Health Care client in Nashville, TN. The successful candidate will have experience within the Health Care Regulatory / Compliance space with at least two years of Clinical Outcomes experience.
SUMMARY OF KEY RESPONSIBILITIES:
This position will have the overall responsibility for researching, writing, and editing clinical reports, protocols, and other related documents in the Clinical Outcomes area. The Medical Writer will work in conjunction with the Clinical Outcomes team and Program Manager to adapt Standard Operating Procedures for the Clinical Outcomes team.
Duties and Responsibilities:
- Write clinical documents associated with submissions to regulatory authorities including but not limited to: study protocols, informed consents, clinical study reports, periodic regulatory reports
- Serve as the Medical Writing representative on assigned project teams, providing timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
- Responsibility for medical writing document version control for study documents created by Medical Writing department, as applicable
- Identify any potential project challenges including changes in project plan, timeline or out of scope requests, and suggest possible resolution options to the program manager
- Perform literature searches/reviews as necessary to obtain background information and training for development of clinical documents.
- Serve as the primary contact for clinical document writing on an assigned project
- Ensure medical editing review of draft and final documents before external distribution. This includes both copyediting and content review.
- Maintaining consistency of style and developed formats, templates, content for IND submissions, and guidelines for clinical documentation in support of scientists.
- Preparation of Investigator’s Brochures and other documentation in support of clinical programs including study abstracts and regulatory documents.
- Assisting clinical and regulatory teams prepare and write phase I-IV clinical and regulatory documents such as clinical study protocols, study reports, Annual regulatory reports, etc.
- Preparation of clinical documents in accordance with templates, global standards, FDA, ICH, and GCP guidelines and in accordance with electronic publishing standards (when applicable).
- Participate in departmental or interdepartmental process improvement and training initiatives.
- Participate in development of templates and guidelines for clinical documentation and workflow procedures.
- Assist in the development of departmental SOPs.
- Knowledge: A body of information needed to perform tasks; May be obtained through education, training or experience
- Thorough understanding of GCP, ICH guidelines
- Knowledge of FDA and EMA regulations
- Skills: The proficiency to perform a certain task
- Excellent problem-solving, planning, analytical, and organizational skills.
- Strong Microsoft Word and Excel skills
- Strong verbal, written and interpersonal communication skills
- Flexible attitude with respect to work assignments and new learning opportunities.
- Ability to multitask and prioritize workload with attention to detail required
- Abilities: An underlying, enduring trait useful for performing duties
- Ability to work within deadlines.
- Adhering to SOPs and applicable Guidance Documents.
- Participating in educational activities and programs.
- Maintaining strictest confidentiality.
- Minimum Required: Bachelor's College Degree (4 year program)
- Preferred: Master's Degree (1-2 year program)
- Two to three years minimum of relevant medical writing experience or relevant clinical research experience.
- Two years of experience as a CRA/Study Manager, compliance auditor, or a combination in healthcare, clinical research or other science-related field.
- Experience with preparation of clinical study-related documents and/or research publications desired; experience with regulatory documents and processes beneficial.
- Clinical research/medical writing experience: experience, including phase I- III, in writing multiple clinical study reports, and either CTD documents or similar, or study protocols
If you are interested in learning more about this opportunity, please contact Cindy Raleigh at firstname.lastname@example.org or 702-645-9860.