We offer an excellent opportunity to join our Clinical Affairs team, based in Bussolengo (Verona), as Medical Writer.
In this role you will work in a team environment to help develop global evidence-based clinical strategies for orthopedic medical devices by creating clinical documentation that systematically synthesizes information from multiple data sources.
You will plan and develop clinical evaluation reports (CERs), post-market clinical follow-up (PMCF) reports, as well as a summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs.
Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements. You will interact mainly with departments involved in product development (e.g. Innovation, R&D, Regulatory & Quality, Sales & Marketing, PMO) in the company both at local and international level including relationships with US colleagues. You will also engage with external consultants, regulatory agencies and scientific organizations/companies.
What will your contribution be?
- Reviewing medical scientific literature, analyzing clinical risk and providing benefit/risk assessment, write, review and edit CERs to comply with international regulations.
- Write and update coherently and convincing CERs and PMCF Reports by organizing and evaluating large amounts of scientific/clinical/medical data.
- Prepare and update SSCP, according to the SOP, based on the CER and other sources, including the part for lay persons.
- Write and update CEPs and PMCF Plans.
- Work collaboratively with cross-functional partners.
- Prepare answers to the Notified Body or Regulatory Agency requests.
- Assist with other clinical, marketing and regulatory projects assigned.
- Acquire, interpret, analyze and draw conclusions from clinical data from clinical trials, literature and experiences for a wide variety of medical devices.
- Communicate scientific content in a clear, concise manner.
- Mentor and train new incoming team members about procedures and best practices.
- Preparing clinical collaterals in collaboration with Medical Affairs and Marketing
- Performing ad-hoc literature searches and analyses
- Where necessary, involve and managing outside consultants, vendors and experts (HCP and technical experts) for the execution of the above-mentioned activities
What are we looking for?
- PhD is required, preferably in medical or life sciences
- Previous 1/3 years work experience in similar roles, preferably in innovation-oriented companies or operating in the mechanics or mechanical components sector
- Knowledge of ISO 14971, AIMDD, MDD, MDR, MDCG, CMDCAS/ CMDR, JPAL and other international regulatory agency requirements.
- Experience with literature research, publications, and journal articles.
- Familiarity with citation management software.
- American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Medical Devices.
- Knowledge with Design History File, Technical File, Design Dossier, Clinical Study Report, and Clinical Evaluation Report content templates.
- Working knowledge of current electronic document management systems and information technology.
- Good English knowledge written and spoken
- CERs, post-market clinical follow-up (PMCF) reports expirience
What soft skills are we looking for?
- Able to assimilate and interpret scientific content and translate information for appropriate audience.
- Able to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Able to manage time efficiently and prioritize tasks.
- High attention to detail and accuracy.
- Able to manage complex tasks.
- Strong interpersonal skills, ability to work with teams and be a self-initiator.
What will you find?
- A dynamic, international, and inclusive work environment.
- A friendly and collaborative team atmosphere.
- Training and development opportunities.
- Smart Working
- Competitive reward packages.
- Social and company events.
- Wellbeing initiatives (welfare).
- Canteen.
- Benefits (Pension Fund – Health Insurance).
What do we offer?
- Full-time permanent position.
- Salary package: around 40k/45k (depending on seniority and skills).
Do you want to join us? Are you ready to make the difference? We look forward to your application. Please send it to [email protected]
