The Medical Writer will be responsible for developing clinical, scientific and regulatory documentation in support of clinical research studies, scientific literature and regulatory submissions for spine surgery products. This role will partner closely with marketing, regulatory and clinical to provide the necessary documentation in domestic and international markets.
Essential Duties and Responsibilities
- Drafts and develops Clinical Evaluation Reports (CERs) for submissions to regulatory bodies, including the EU, US and various APAC regulatory entities to establish and maintain global regulatory compliance.
- Works directly to support the clinical, non-clinical, and regulatory teams by authoring documents and managing the document review process.
- Develops SOPs and best practices for the process of document review, completion, and approval, ensure adherence to regulatory requirements and industry standards, where applicable.
- Creates/revises relevant document templates and style guides as needed.
- Provides effective communication to support clinical research study activities, including management of projects with external contractors and business partners.
- Reviews and provides input on data for publication to ensure alignment with current medical issues and corporate strategies.
- Supports the creation or revision of product labeling and risk management files.
- Authors and assists in writing of scientific abstracts, presentations, reports, and publications.
- Conducts literature searches and data gathering activities to support various internal/external education and clinical strategies.
- Ability to interpret and summarize statistical results of clinical studies and present the data in a clear, concise, and scientifically accurate manner to a wide range of audiences.
- Provides guidance on analysis and presentation of clinical and safety data, including risk/benefit assessments, for Post-Market Surveillance (PMS) activities.
- Requires BS/MS/PhD/PharmD/MD degree in Medical Science, Life Science, Science, Nursing, or Engineering, and a minimum of 3+ years of experience in medical device studies and/or clinical study support or with the completion of clinical trial programs.
- Outstanding communications skills - both written and verbal. Possesses both technical and organizational skills and the awareness needed for effective and open communication.
- Experience in Clinical Evaluation Reports (CERs).
- Strong emphasis on medical terminology and/or research methodology.
- Proficient with Microsoft Outlook, Word, Excel, EndNote
- Must have experience with Electronic Data Capture programs.
- Strong knowledge of regulatory and quality guidelines related to clinical research studies.