Mectron spa, medical and dental device design and manufacturing company, is looking for,
Medical Writer -Clinical Affairs Specialist
Position
Medical Affairs Clinical Specialist will contribute to the entire product lifecycle by meticulously documenting, gathering, and, when required, generating clinical evidence. In this role, the resource will play a crucial role in establishing and maintaining a positive residual risk/clinical benefit profile for medical products in the market. The contribution will be essential in effectively communicating the safety and efficacy of our products in a clinical context, thereby contributing to the overall success of our presence in the medical market.
Essential duties:
* Support the definition of product requirements by providing R&D and Marketing/Sales input specification to align the products with the latest clinical guidelines and best practices.
* Lead the Clinical Evaluation Process collecting, evaluating, and analyzing clinical data to assess the device's compliance with essential safety and performance requirements.
* Skilled in writing Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post Market Clinical Follow-Up Plan (PMCF Plan), and Post Market Clinical Follow-Up Report (PMCF Report).
* Advanced skills in performing SOTA researches and analyzing cumulative data to support validation activities.
* Contribute to the definition and execution of the Product Validation Plan. Identify new product features or requirements that may have safety concerns and release the Clinical Evaluation Plan.
* The role is accountable for drafting and approving all the Clinical Evaluation documentation for CE, FDA and principal markets submission;
* Drive the Post Market Clinical Follow-up Process by coordinating with other corporate functions, systematically collecting and reviewing post-market information to monitor clinical performance and safety. Update the clinical evaluation and risk/benefit profile as needed, and release/update safety reports.
* Contribute and participate in Medical Device Reporting (MDR) activities. Evaluate, from a clinical standpoint, the severity and probability of risks related to incident or potential incident reports in the Risk Management process.
* Be in contact with the Key Opinion Leaders to define clinical strategy and assessments.
* Contribute to drafts, reviews, and approves key regulatory documents for submission to the US Food and Drug Administration (FDA) and other health authorities, including the Clinical Study Report and Common Technical Document, if appropriate;
* Participates in the MLR (Medical, Legal, Regulatory) process about evaluating all branded marketing promotional materials and unbranded non-promotional scientific exchange materials. Evaluate the medical quality of all materials ensuring that guidelines and code of federal regulations are maintained. Understand and interpret guidelines on advertising and promotion;
* Reviews promotional and non-promotional materials to ensure accuracy and compliance with internal and external guidelines, requirements, and regulations;
* Contributes to the development of unbranded disease state and branded product-specific educational materials (i.e. slide decks, publications, monographs, scientific books) for presentation and engagement with internal (marketing and other groups) and external audiences (health care providers, public health, and lay public);
Position capacities:
* Strong methodology. Accuracy and reliability.
* Ability to meet deadlines.
* Team-oriented mindset.
Work Experience – Required Qualifications
* 1/2 years of Experience in medical writing preferred;
* Fluency in English required;
* Additional written and spoken languages preferred.
Educational Requirements
Bachelor’s degree in medical field or similar, eg biomedical engineering, science, chemistry, biology, or a related field required.