Overview
Combining knowledge of science with the understanding of research, the Principal CER Specialist/Medical Writer will support the development and creation of clinical and scientific documents to present information effectively, with clarity and in accordance with procedures and corresponding regulations. This includes conducting literature reviews, writing Clinical Evaluation Plans and Reports for submission to regulatory bodies, and various activities including abstracts and manuscripts in alignment with the core business strategy.
The candidate will be working cross-functionally and will collaborate with internal stakeholders, to include Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well as external stakeholders, to include FDA, NB, PMDA, KOL, HCP, IRB and publishers. The candidate should have a strong background in the clinical evaluation process, with a track record of successfully managing the remediation of medical devices from MDD to MDR using various clinical evaluation strategies. This individual will need to stay current on the changing requirements and guidance from the Notified Bodies, particularly BSi, and the ideal candidate will have experience working through NB deficiencies to conclusion. Experience with NB audits would also be ideal. Additional responsibilities include providing input to product development and post-market sustaining core teams.
This individual will have visibility to senior leaders and needs to be comfortable presenting program updates using PowerPoint over Zoom or in person. This role will require training on the Cordis product portfolio and a baseline understanding of the therapy and disease states is preferred.
The position reports into the Sr. Director of Global Clinical and Medical Affairs
Responsibilities
Execute general medical writing, editing, and proofreading activities and systematic literature reviews for assigned CER projects
Develop CEPs, CERs, PMCF plans and evaluation reports, and SSCP reports in accordance to EU MDR requirements
Provides the overall needs and schedule driving post-market clinical follow-up (PMCF) data collection activities
Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process.
Be a key collaborator with the biostatistics and data management team for complete results interpretation and to ensure the delivery of accurate and relevant output
Represents the Clinical/Medical Affairs function and Clinical Evaluation Team on the EU-MDR Core Team(s), working closely with Core Team Leads on timelines and clinical needs
Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines (e.g., MDD and MDR), and company templates
Communicates with stakeholders and obtains stakeholder alignment to ensure business objectives are met
Contributes to the strategic approach for the team’s clinical evaluations with consideration of the portfolio-level view of other strategic approaches and NB feedback.
Mentors junior team members on the clinical evaluation processes and supports documentation decisions for Clinical Evaluation Specialists.
Assist in developing and implementing corporate procedures for medical and regulatory writing
Assist research and other project team members in additional responsibilities as required
Support Quality audits
Qualifications
Bachelors degree in the field of biological science , statistics,medical science required with 5 years of relevant experience, or advanced degree (e.g., MS, MA, MPH, PharmD, PhD, DVM, MD) with a minimum of 3 years of relevant medical writing experience
Direct experience authoring clinical evaluation documents, including: PMCF Plans, PMCF Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, and Summary and Safety and Clinical Performance
Proficient knowledge of physiology and/or applicable disease states, medical terminology
Experience presenting scientific/clinical evidence in a written and oral manner to cross-functional teams.
Familiarity with international regulatory requirements and knowledge of relevant standards (e.g. ISO 14155, ISO 14971, MedDev 2.7.1 rev 4, EU MDR, applicable MDCG)
Working knowledge of various writing style guidelines (e.g., AMA) and current publication practices and guidelines (ICMJE)
Experience planning and executing internet literature searches using databases such as PubMed, Embase
Working knowledge of biostatistics
Experience working with Quosa, Endnote or other literature repository and citation management tools
Demonstrated ability to build positive constructive relationships with cross-functional team members
Core skills:
Excellent scientific writing skills
Excellent level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), scientific search engines (PubMed, Google Scholar, Embase ), and online journal/conference submission systems
Strong data extraction and analysis skills
Proactive with a sense of urgency in managing job responsibilities
Self-motivated and able to work independently.
Analytical thinking and inquisitive mindset
Ability and desire to develop good working relationships internally and externally
Strong ability to multitask and work effectively in a fast-paced environment with changing priorities
