Manager, Medical Writing - R&D Partners

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

• 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)

• 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.