Job Type: Clinical
Job Number: JN -102024-32830
Region: Orange County Metro Area
Job Description
R&D Partners is seeking to hire a Manager, Medical Writing in Irvine.
Your main responsibilities as a Manager, Medical Writing:
- Plan and lead the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables.
- Negotiate deliverable timelines and resolve project-related issues with cross-functional partners including Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, and Biostatistics.
- Provide mentoring and knowledge transfer for Medical Writing team members.
- Act as representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies.
- Lead the identification, recommendation, and implementation of continuous process improvements as it relates to medical writing.
What we are looking for in a Manager, Medical Writing:
- Bachelor's Degree in a related field with 8 years of related scientific experience or Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in a related field with 6 years of related scientific experience.
- Experience as a Medical Writer for a medical device company; cardiovascular medical device company highly preferred.
- Extensive experience authoring EU Clinical Evaluation Plans and Reports, Post market Clinical Follow-up Plans and Reports, Summary of Safety and Clinical Performance and applicable reports.
- Extensive knowledge on conducting focused searches within medical literature databases (e.g., PubMed, Medline) and ability to evaluate/summarize content.
- Proven expertise in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote) and database systems (e.g., Medline or PubMed).
Why Choose R&D Partners?
As an employee, you have access to a comprehensive benefits package including:
- Medical insurance PPO, HMO & HSA
- Dental & Vision insurance
- 401k plan
- Employee Assistance Program
- Long-term disability
- Weekly payroll
- Expense reimbursement
- Online timecard approval
Salary: $96,245 to $120,307 (Dependent on Experience)
R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
R&D Partners is an equal-opportunity employer.
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