Staff Medical Writer

1 Edwards Way, Irvine, CA 92614, USA

Full-TimeDepends on ExperienceMid-LevelPhd or Professional

Job Description

Support regulatory submissions and other associated activities by authoring CEP’s and CER’s in compliance with 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 and providing input from the CER into other reports (e.g. clinical evaluation plans and reports, Postmarket Clinical Follow-up Plans and Reports (MEDDEV 1.12/2, rev 2, MDCG 2020-7, MDCG 2020-8) period safety update reports, post-market surveillance reports, Summary of Safety and Clinical Performance (MDCG 2019-9), etc.), including performing literature searches. Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional teams to understand upcoming medical writing needs and manage resourcing and assignments to ensure timelines are met.

Where is this job?

This job is located at 1 Edwards Way, Irvine, CA 92614, USA

Job Qualifications

Ability to work and excel within a fast paced, dynamic, and constantly changing work environment
4 years experience of related scientific experience required
Proven successful experience with Class II and Class III devices and Clinical Evaluation Plan (CEP)
Expert product knowledge including current developments, clinical literature review, and therapeutic and product operation knowledge
Expert knowledge of biomedical statistics is preferred

Required Skills

MS Word
MS PowerPoint
Time Management Skills
MS Excel skills
Endnote
Relationship management and influencing skills

Soft Skills

Detail Oriented
Prioritizing skills
flexibility
Organizational skills
Verbal and Written Communication
Driven for excellence

Compensation

According to JobzMall, the average salary range for a Staff Medical Writer in 1 Edwards Way, Irvine, CA 92614, USA is $80,000 to $100,000 per year. This range can vary depending on experience, education level, and the industry in which the writer works.

Additional Information

Edwards Lifesciences is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedAugust 2nd, 2021

Apply BeforeJune 9th, 2026

This job posting is from a verified source.

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