Description

Summary:

The Clinical Evaluation Report (CER) Writer is responsible for creating regulatory submission documents related to Clinical Evaluation Reports (CERs). This position includes client interaction and responsibilities for mentoring and supervising the work of other CER Writers. The Clinical Evaluation Report (CER) Writer may be an employee (full- or part-time) or a consultant (temporary role).

Responsibilities:

Tasks may include but are not limited to:

• Independently writing, editing, reviewing, and formatting documents that conform to client-based regulatory submission guidelines and internal document standards (CERs, Clinical Evaluation Protocols [CEP], Post-market Surveillance [PMS] Plans, Post-market Clinical Follow-up [PMCF] Plans, Summary of Safety and Clinical Performance [SSCP], etc.), while meeting project deadlines.

• Coordinating content development with multi-discipline subject matter experts, both internal and external to Global.

• Attending meetings about document(s) in development and providing both internal and external management, team, and reviewers with timelines and document status reports as needed.

• Providing mentoring and training for CER Writers.

• Collaborating with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.

Skills and Abilities:

• Understanding of EU regulations and guidelines related to medical devices including: MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; and MDR 2017/745.

• Comfort working in a regulated industry that demands conformance with regulatory requirements and a high level of quality, integrity, and scientific accuracy.

• Proficiency with Microsoft Office 365. Advanced user of Word (styles, hyperlinking, numbering, etc.) and Excel (using formulas, organizing data, advanced sorting, etc.). Experience using Teams, Outlook, and SharePoint. Experience with referencing software such as EndNote.

• Strong understanding of data analysis and statistical methods.

• Ability to plan and execute systematic literature reviews (state of the art and device-specific): preparing search queries, selecting appropriate search databases and conducting the searches, creating and applying systematic inclusion/exclusion criteria, appraising literature. Experience with literature management tools such as QUOSA or Distiller is a plus.

• Vigilance database searching and interpretation of results (FDA MAUDE, FDA Recall Database, etc.).

• Ability to synthesize complex technical or clinical information/data in a clear, concise, and accurate manner.

• Ability to determine the appropriate medium for synthesizing information such as prose, lists, tables, graphics, figures, flow charts, etc.

• Independent and self-driven: strong problem-solving skills, timeline management skills, and organizational skills, and high attention to detail.

• Ability to manage multiple projects and timelines simultaneously.

• Experience working with clients or vendors is a plus.

• Ability to develop CER strategies.

Requirements

Requirements:

• Minimum of a BA or BS in science, engineering, or medical field; advanced degree strongly preferred.

• 1-5 years of medical writing experience in the medical device industry or medical writing.

• Oral and written fluency in English is required.

• Strong command of medical and surgical terminology.

• Experience writing CEPs and all sections of CERs. Experience conducting quality reviews of CEPs and CERs is a plus.

• Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports.

Location and Travel:

• Position is fully remote. Employees are expected to have an appropriate remote working environment.

• Occasional travel for team retreats, client-facing meetings, and conferences (<10%).

Note: This job description is a summary of the job and requirements that are essential to the position. Global reserves the right to modify, interpret, or apply this job description as appropriate. This job description does not imply that these are the only duties to be performed by the person in this position. This job description is not an employment contract.

Global Regulatory Writing & Consulting (GLOBAL) jobs

Clinical Evaluation Report (CER) Writer