USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Medical Writer-Clinical Evaluation Reports
The Medical Writer will primarily focus and be responsible for review and research of medical and scientific literature in order to author Clinical Evaluation Reports (CERs) and maintain and update existing CERs. In addition, the Medical Writer may contribute toward or author other technical doc‐uments that support clinical and regulatory efforts of the company.
Essential Responsibilities and Duties
Authors Clinical Evaluation Reports (CERs) and maintains/updates existing company CERs according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR.
Contributes toward post-market clinical safety (e.g. post-market clinical follow-up plans and reports) and risk management programs as requested.
Critically appraises scientific literature and writes summaries for articles, products and clinical application of products
Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
Manages timelines and communication to ensure deliverables and milestones are met.
Prepares for and participates in audits as needed.
Interacts with internal and international teams (engineering/marketing/regulatory) to define the plan and strategy for development of the Clinical Evaluation Reports for new products requiring CE Mark.
Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
Other duties as assigned
Minimum of Bachelor’s Degree or equivalent in scientific or medical discipline; Master’s Degree preferred
Minimum of 3 years of experience in clinical evaluation report writing in the medical device industry.
Knowledge and experience with Medical Devices Directive 93 / 42 /EEC
Knowledge and experience with MEDDEV 2.7.1 Rev 4 Clinical Evaluations
Knowledge and experience with MEDDEV 2.12-2 PMCF
Knowledge and experience with EN ISO 14155 Clinical Investigations
Knowledge and experience with ISO14971 Risk Management
Experience and skill performing medical literature searches (PubMed, Google Scholar, etc.)
Excellent written communications skills-- strong attention to detail related to consist‐ency, grammar, syntax, and accuracy
Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
Basic project/timeline management skills and organizational skills
Ability to prioritize and manage multiple projects
Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures
Strong familiarity with Microsoft Office
Experience as a medical professional preferred, preferably in emergency care settings
Disclaimer: This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
USDM Life Sciences is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran, disabled, or any other protected status.