Job Description

Manager, Medical Writing
Irvine, CA
Schedule: Standard Office Hours, Open to Hybrid or Remote workers
Duration: 6-Month Contract
Pay Range: $52-57/hr
Our client is a global leader in medical technology specializing in cardiovascular devices and innovations.
Job Responsibilities
In this role, you will manage and support a variety of projects within the Medical Writing department. Key responsibilities include:

• Planning, developing and leading the completion of complex medical writing projects in a fast-paced environment with accountability for successful completion within scope of project deliverables including negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (e.g., Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.)

• Acting as a technical expert to key stakeholders to develop and lead the implementation of corporate, business unit, and departmental process updates and improvements (e.g., MDR compliance, etc.)

• Providing direction and guidance for smaller projects to execute medical writing projects and/or initiatives. Providing mentoring and knowledge transfer for Medical Writing team members

• Acting as representative in core team meetings in the development of reporting plans and regulatory submissions (US and international) for clinical studies

• Leading the identification, recommendation and implementation of continuous process improvements as it relates to medical writing

• Collaborating with cross-functional teams and stakeholders to ensure project success

• Other duties as assigned

Knowledge & Skills

• Ability to discuss complex scientific and technical subjects with stakeholders

• Ability to provide leadership and guidance; skilled in coaching and training techniques

• 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)

• Extensive editing and proofreading skills

• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

• Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards

• Extensive understanding of related aspects of the medical writing processes and/or systems

• Knowledge of biomedical statistics

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Ability to represent leadership on sections of projects within a specific area interfacing with project managers and cross-functional teams

• Ability to consult in a project setting within specific sections

Education & Experience
Required:

• Bachelor's Degree in a related field and 8 years of related scientific experience OR Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) in a related field and 6 years of related scientific experience

Preferred:

• 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 (CEP, CER, respectively) in compliance with applicable regulations/guidance's (e.g., MDD 93/42/EEC as amended by 2007/47/EC, MED DEV 2.7/1, rev 4, MDR 2017/745, MDCG 2020-1, MDCG 2020-5, MDCG 2020-6)
• Post market Clinical Follow-up Plans and Reports (e.g., MEDDEV 2.12/2, MDCG 2020-7, MDCG 2020-8)
• Summary of Safety and Clinical Performance (MDCG 2019-9)
• Any other applicable reports
• Extensive knowledge on conducting focused searches within medical literature databases (e.g., PubMed, Medline) and ability to evaluate/summarize content
• Familiarity with quality systems and regulatory requirements for medical devices is highly desirable
• Certification in related field is a plus

...

Skills Required