Senior Medical Writer

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in ensuring product-line compliance with relevant US and international regulations and standards.

• Draft clinical regulatory documents such as annual reports, study summaries, and rationales for studies.

• Aid in meeting clinical requirements for regulatory submissions and ongoing product maintenance.

• Organize deliverables encompassing CEP, CER, PMCF activities, and SSCP processes to comply with MDR standards.

• Manage company deliverables and ensure team members adhere to project timelines.

• Conduct literature reviews and compose research summaries related to products.

• Assist in the preparation of product Instructions for Use (IFUs) and support labeling modifications and translations.

• Present and disseminate clinical data effectively.

• Develop and sustain relevant clinical research databases.

• Produce interim analyses, slides for investigator meetings, and final clinical study reports.

• Engage in communication with physicians, vendors, and other medical professionals.

• Report adverse events, complaints, and product failures identified during the writing process.

• Coordinate peer-reviewed projects, which include publications, posters, abstracts, and marketing materials.

• Oversee timelines, budgets, budget change forms, accruals, and monthly reports for projects supported by vendors.

• Create clinical study documents, including protocols, investigational plans, informed consent forms, handouts, SOPs, and status reports.

• Act as a liaison between Artivion, investigational sites, and CROs to coordinate and document final reports and publications.

• Undertake additional responsibilities as assigned, including tasks at a higher level than the current title.

⛳️ Requirements

• At least 3-4 years of experience in writing within the medical or biomedical sectors.

• A BS or MS degree in biological science, epidemiology, engineering, statistics, or another science-related discipline.

• Familiarity with regulatory requirements for medical devices, including Clinical Evaluation Reports and Post Market Requirements.

• Proficiency in writing and editing high-quality medical abstracts, white papers, manuscripts, and other educational content.

• Experience in conducting literature searches and analyses.

• Competence in computer skills, including spreadsheets and relational databases.

• Superior written and verbal communication abilities.

• Strong interpersonal skills.

• Capability to manage multiple projects simultaneously.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodation available for applicants with disabilities.