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Medical Writer III
Ref No.: 17-07032
Location: Irvine, California
Start Date / End Date: 01/15/2018 to 01/13/2020
Spotlight call: Wednesday, November 22nd at 1:00pm Central Time
Call in number: 1-415-655-0003 US Toll
Access code: 921 078 325

The Medical Writer III role in our Medical Affairs organization supports the Global Neurovascular business unit. This Writer will work closely with investigators; develop podium presentations and journal articles in accordance with the highest quality standards from the clinical data generated from clinical trials conducted in the field of neurovascular medicine with a focus on treatment of intra-cranial aneurysms.

sit on site irvine. focus on publication writing.

A Day in the Life

• Develop and manage publication plans for Healthcare Neurovascular sponsored clinical studies

• Develop scientific communications (e.g., abstracts, manuscripts, podium presentations) in close collaboration with study investigators/KOLs, and internally with statisticians, and clinical trial team members

• Lead discussions on publication revision and finalization; coordinate and manage review processes, revise abstracts/presentation slides/manuscripts as per comments from internal & external reviewers

• Ensure scientific communications are developed with study investigators in compliance with ICMJE guidelines, CONSORT, and ISMPP Code of Ethics

• Lead the cross-functional Publications Working Group meetings

• Conduct literature searches, manage the literature database and prepare literature reviews for external and internal clients

• Collaborate with the Regulatory Affairs and Clinical Affairs teams; provide support with submissions to regulatory agencies by drafting clinical sections of submissions/literature summaries

• Participate in the periodic reviews of recent scientific publications and online content relevant to the business; draft article summaries for distribution to key stakeholders

• Attend major national & international conferences to keep up to date with advancements in the field; contribute to the development of conference coverage reports for internal distribution

Minimum Requirements

• Advanced degree in a scientific discipline (Master's degree, Ph.D., MD) with 3+ years’ experience in the medical device/pharmaceutical field with an Advanced degree, or a minimum of 7+ years with a Bachelor's degree

• Experience in the development of clinical, scientific, and regulatory documents

• Excellent project management and organizational skills

• Working knowledge of statistics is required

• Excellent writing and editing skills, and a keen attention to detail

• Strong verbal, written, and interpersonal communication skills

• Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail

• Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases

• Demonstrated ability to meet project goals within a matrix environment