Job OverviewResponsible for the generation and development of documents relating to clinical evaluations and clinical investigations.
This position is hybrid or fully remote in the US preferably on EST zone.
This is a fixed term position with direct hire with Getinge with a high potential to convert to regular hire.
Job Responsibilities and Essential Duties - Serves as a clinical evaluation lead and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Reports (CER) and associated documentation. Specifically contributes to the planning, literature review and the identification, appraisal and analysis of clinical data related to the evaluation in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR. Contributes to the Summary of Safety and Clinical Performance in alignment with EU MDR.
- Serves as point and participates in the Post-Market Clinical Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation.
- Performs comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required. (20%)
- Analyzes available clinical evidence (data held by the manufacturer, published literature) to assist the Clinical Affairs team with clinical development strategy.
- Writes and or edits clinical study documentation, including clinical investigational plans/protocols, Investigator's Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution.
- Serves as a subject matter expert on clinical aspects of Technical documentation.
- Writes and/or supports the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals. Works with medical professionals to ensure alignment with journal requirements for targeted manuscript submission.
- Writes and/or contributes to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity.
- Contributes to the development and optimization of Clinical Affairs SOPs.
- Performs other non-routine duties as assigned.
Required Knowledge, Skills and Abilities - Bachelors Degree in a relevant scientific discipline, or equivalent combination of education and experience.
- A minimum of 3 years medical writing experience. Direct experience working on clinical evaluations within the Medical Device industry a plus.
- Medical writing certification a plus.
- A high level attention to detail and the ability to own and drive accuracy.
- Strong interpersonal and communication skills.
- Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.
- Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions
- Outstanding oral and written communication skills.
- Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review tools a plus.
- Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, relevant MDCG guidance, ISO 14155, ICH guidance including E3 CSR, E6 (R3) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO14971)
- Demonstrated ability to work independently and as part of a team.
- Ability to interact with physicians in a professional manner.
- Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
- Advanced skills using Microsoft Office products such as Outlook, Word, Excel and Power Point.
- Travel requirements depending on projects.
Internal and External Contacts/Relationships - Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering, Research & Development and Marketing, as needed.
- External teams such as CROs, clinical vendors and key opinion leaders.
The base salary for the position is a minimum of $105,000 and a maximum of $115,000
#LI-JF1 #LI-remote
Benefits at Getinge:At Getinge, we offer a comprehensive benefits package, which includes:
- Health, Dental, and Vision insurance benefits
- 401k plan with company match
- Paid Time Off
- Wellness initiative & Health Assistance Resources
- Life Insurance
- Short and Long Term Disability Benefits
- Health and Dependent Care Flexible Spending Accounts
- Commuter Benefits
- Parental and Caregiver Leave
- Tuition Reimbursement
