We are currently seeking a talented professional who is interested in evolving with the company, for a part time role of CER Medical Writer.
This role is integral in supporting our clients maintain compliance and obtain regulatory clearance for medical devices in Europe and other regions.
Success in this role requires gaining deep understanding of the CER strategy and timelines of the client and meeting the deadlines in a quality manner. Effective communication, flexibility with an entrepreneurial environment, and high professional integrity are integral to working with EBC.
This is a part time role done remotely with occasional in person and onsite meetings. Canadian permanent residency or citizenship is required.
Working with the Medical Device companies pursuing compliance with the EU MDR regulations, MDD or AIMDD, and seeking clearance of their devices in EU and other regions, the CER Medical Writer will primarily be responsible for authoring and updating the clinical evaluation package which may include all or some of the following components: Clinical Evaluation Plans, Clinical Evaluation Reports (CEP, CER), Summaries of Safety and Clinical Performance (SSCPs), Post Market Surveillance Plans and Reports (PMS P, PMS R), Post Market Surveillance Follow Up Plans and Reports (PMCF P, PMCF R), and Product Safety Update Reports (PSURs). Any combination of these reports is referred to as the CER package in this job description.
Furthermore, the role may contribute to drafting of technical or scientific publications that support medical, clinical, and regulatory efforts of client companies.
Successful candidate shall be knowledgeable and proficient in writing the components of CER package, dependable, flexible, solution oriented, and a strong team player.
· Executes on all aspects of drafting brand new or updated CER package for a variety of medical device classes (Class I-III) and therapeutic areas, according to EU MDR and MEDDEV 2.7.1, Rev. 4, MDD and AIMDD as applicable.
· Conducts literature searches in various databases such as PubMed, Embase, Google Scholar, Cochrane.
· Critically screens, and appraises scientific literature, extracts appliable data points, drafts summaries, and carefully documents the process and results.
· Thoroughly evaluates clinical evidence to assess the safety and performance outcomes of the device and clearly reflects the assessment in the CER.
· Collaborates with client’s internal cross functional teams per the procedure and structure of the client) and follows plans and strategy for development of the CER packages for products requiring CE Mark.
· Drafts all sections of the documents including State of the Art, post market surveillance, device description, equivalence, benefit risk analysis, discussion of safety and performance, conclusions, and executive summaries.
· Acquires in-depth knowledge of the subject device, competitor devices, state-of-the-art, current clinical/market developments, relevant medical literature.
· Conducts proofreading, editing, formatting, addressing reviewer comments and document completion/approval activities.
· May participate in responding to queries of the notified bodies related to the CER package.
· Completes all required trainings of the client companies and adheres to the processes of EBC.
· Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
· Manages workload and adhere to timelines of deliverables.
· May work with more than one client or on multiple projects at a time.
· Contributes to and participates in document audits as needed.
· May contribute to draft of white papers, presentation materials, manuscripts, poster content, and other publications.
· Provides regular updates to the CEO, communicates roadblocks, project challenges and accomplishments regularly
· Other projects and duties as assigned
· PhD, MD, or master’s degree in a scientific discipline
· Minimum of 2 years’ experience in writing CEP, CER, SSCP, PMS P, PMS R, PMCF P, PMCF R, and PSURs under MDD and EU MDR for Class I, IIa/IIb, and III devices
· Experience in areas of Regulatory Affairs, Clinical Affairs, Quality Engineering, or Medical Writing
· Excellent analytical and communications skills, strong attention to detail, consistency, grammar, syntax, and accuracy
· Canadian citizenship or permanent residency
· Experience working at prominent medical device corporations a plus
· Knowledge and experience with EU MDR regulations (EU) 2017/745, MEDDEV 2.7.1 Rev 4 Clinical Evaluations, MEDDEV 2.12-2 PMCF, MDCG 2019 guidelines.
· Knowledge/experience of EN ISO 14155 Clinical Investigations and ISO14971 Risk Management
· Experience performing literature searches in PubMed, Google Scholar, Cochrane
· Proficient in use of Microsoft Office, particularly Microsoft Word and Excel
· Able to identify critical information, maintain confidentiality of client data, identify, and escalate roadblocks and project risks
· Time management and organizational skills
· Able to prioritize and manage multiple projects
· Able to thrive in a small team and start up environment
· Self-starter with ability to self-educate on different medical device products
· Cognizant of ramifications of non-compliance
· Able to thrive in a small team environment and to handle multiple projects at one time