Medical Writer

The medical writer is responsible for a subset of deliverables associated with Global Clinical Affairs functions. This role collaborates closely with Clinical Operations, Clinical Development, Research & Development, Regulatory Affairs, Quality Assurance, and other key internal stakeholders to draft, edit, and finalize key documentation - including clinical study protocols, clinical study reports, abstracts, case report forms, standard operating procedures, regulatory submission documentation, etc. Supporting the business needs of Global Clinical Affairs. The medical writer provides clinical and/or technical expertise across multiple areas of business and requires top-level competency in scientific writing, systematic literature reviews, Good Clinical Practice (GCP), and data analysis.

Responsibilities:

Writing Clinical Performance Reports for CE-marked products in compliance with IVDR (EU) 2017/746
Clinical Research, including Systematic Literature Searches and reviews
Clinical process development and Standard Operating Procedure writing
Clinical Evidence planning and evaluation
Clinical Research Reports
Clinical Research Abstracts and Excerpts
Support the development of Case Reports Forms
Documentation for Regulatory Submission
Technical Documentation and SAE management for Clinical Trials
e-learning Modules Writing
Writing Medical Cases
Interfaces closely with regulatory department in preparing narratives for submission.
Clinical Risk Assessment

Qualifications

Education: Bachelor’s Degree is required, Master’s Degree (M.S., M.A., MBA, etc.) preferred.
Experience: Minimum of 2 years' industry experience (Pharmaceutical, IVD, Medical Device) in technical/ science/ medical writing capacity. Preference to IVD experience desired, but not required.
Strong knowledge of GCP and FDA regulations.
Strong ability to prioritize tasks and keen attention to detail.
Excellent writing, communication, and presentation skills.
Proven ability to work on multiple projects in a fast-paced environment.
Strong interpersonal skills with the ability to interact effectively with multiple levels of within an organization.

Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.