Minimum of 2 years of medical writing experience in the medical or pharmaceutical industry or 5 years of general technical writing experience required
Experience may include writing in a medical, pharmaceutical, medical device, clinical research, or research industry, or a combination of these fields
PSUR writing experience strongly preferred
Literature search experience preferred
Background in biomedical sciences, medicine, or similar health-related discipline preferred
Skills:
Excellent written and verbal communication skills
Experience with collaborative, cross-functional teams
Excellent analytical skills and ability to manage complex tasks and manage time effectively
Proficient with Word, Excel, PowerPoint, Outlook, etc.
High level of attention to detail
Ability to prioritize key business objectives and respond quickly to changing priorities
Ability to work independently with minimal daily instruction
Able to multitask and work in a fast-paced environment
Travel Requirements
Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
This is largely a sedentary role
Operates in a professional office environment and routinely uses standard office equipment
Responsibilities
Write and contribute to Clinical Evaluation reporting deliverables including Post-Market Surveillance Plans and Periodic Safety Update Reports (PSURs), Regulatory Responses, and other related documentation
Evaluate and summarize clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post-market clinical evaluations; analyze results for regulatory submissions and maintenance of clinical evaluation report files
Collaborate with team members and stakeholders in planning for and supporting PSUR-related projects and processes
Support additional clinical, regulatory, quality, and engineering-related deliverables as assigned
Communicate and collaborate effectively with Sales and Marketing, R&D, Regulatory Affairs, Quality Engineering, and Medical Affairs in completing clinical evaluation project-related deliverables
Maintain thorough knowledge of assigned products; identify appropriate sources of relevant data, interpret, evaluate, and incorporate information from various sources including literature, clinical data, and medical references
Review IFUs, patient guides, Risk Management files, Clinical Evaluation Reports and Plans (CER/CEP), clinician training materials, ensuring alignment of risk information; respond to complex queries such as those issued by notified bodies and stakeholders
Author and contribute to necessary documents for regulatory submissions and communications, such as regulatory inquiries
Ensure quality in all deliverables and documentation with attention to detail, consistency, and integrity of data; responsible for compliance with applicable corporate and divisional policies and procedures
Ensure compliance with applicable regulations and guidance (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable ICU Medical SOPs
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Marketing, Public Relations, and Writing/Editing
Industries
Mental Health Care, Wellness and Fitness Services, and Hospitals and Health Care
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