Clinical Evaluation Reporting / Medical Writer (CER)

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

• Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
• Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
• Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
• Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
• Effectively communicates and collaborates with Regulatory Affairs, Marketing Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
• Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
• Reviews IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, to ensure alignment of risk information.
• Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
• Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
• Ensures 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. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.

• Bachelor’s degree in a relevant technical discipline OR an equivalent combination of education and work experience.
• 3 years’ progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment.
• Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
• Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline
• Experience in experimental design, data interpretation, and summarizing clinical data.
• Knowledge of division products and or Quality systems and measures
• 3+ years of medical writing experience in the medical device or pharmaceutical industry or 4+ years general technical writing; CER writing experience
• Relevant experience in a related area such as Clinical Research, Product Development or Quality or in a healthcare industry.
• Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.
• Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills.
• Understanding of medical technology
• Excellent analytical skills and ability to manage complex tasks and manage time effectively
• Proficient with Word, Excel, PowerPoint, Outlook, etc.
• Experience in complaint handling, operation or service of diagnostic instrumentation or medical technology.
• Experience working in a broader enterprise/cross-division business unit model.

Abbott