Think Beyond The Label Jobs

Job Title: Medical Writer II Job Location: St. Paul, MN (55117)/ Santa Clara, CA (95054) - OPEN TO REMOTE Job Duration: 12 Months Job Responsibilities: Writes and contributes to Clinical Evaluation reporting deliverables such as 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 Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, 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, ensuring 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. EDUCATION AND EXPERIENCE Required: A Bachelors Degree is required along with the 4 to 6 years of experience. 4-6 years of medical writing experience in the medical or pharmaceutical industry or 7+ years general technical writing experience required Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry , or combination of these skills CER writing experience required Top Skills Required: Strong communicator both verbally and written Experience working within a Matrix Organization and Cross-Functional Teams Project Management experience where they owned their own projects and supported multiple technical projects MS Excel - Intermediate Level as they will leverage this as a tool to manage projects, data extracting, and screening, Word, and Technical Knowledge Citation Management Systems experience Preferred Biomedical, sciences, medicine or similar health related discipline preferred 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. SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at nahr@spectraforce.com if you require reasonable accommodation.