The Clinical Evaluation Report (CER) Intern is responsible for participating in daily training under the guidance of the Internship Coordinator and other Senior Writers in the CER Team and completing a 12-month training program to become proficient in CER writing tasks. Initially, the CER Intern will complete only non-billable training assignments, but over the course of the program will transition to assignments that support current projects in the CER Team. The CER Intern is a full-time, hourly employee with benefits.
Tasks may include but are not limited to:
• Completing all modules of the CER Writing Internship Program, including all related assignments
• Assisting the CER Team in a supportive role to write, edit, review, and format documents that conform to client-based regulatory submission guidelines and internal document standards (CERs, Clinical Evaluation Protocols [CEP], Post-market Surveillance [PMS] Plans, Post-market Clinical Follow-up [PMCF] Plans, Summary of Safety and Clinical Performance [SSCP], etc.) while meeting project timelines.
• Completing the following tasks under the direction of the CER Senior Associate Writer or CER Manager:
- Article screening in accordance with established inclusion/exclusion criteria
- Appraisal of clinical data
- Summarization of relevant medical articles for the State of the Art and Clinical Literature sections of the CER
- Searches on the MAUDE database for study and/or comparator devices
- Reviews of raw post-market surveillance data and creation of tables and summaries
- Authoring contributions for sections of the CEP, CER, PMCF, and SSCP, as needed
Skills and Abilities:
• (Helpful but not required) Basic familiarity with EU regulations and guidelines related to medical devices including: MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; MDR 2017/745.
• Comfort working in a regulated industry that demands conformance with regulatory requirements and a high level of quality, integrity, and scientific accuracy.
• Experience reading medical and scientific publications. Experience writing for such publications is a plus.
• Understanding of data analysis and statistical methods.
• Ability to synthesize complex technical or clinical information/data in a clear, concise, and accurate manner.
• Strong computer skills, including advanced knowledge of Word, Excel, and PowerPoint. Experience with referencing software such as EndNote and with Office 365 tools such as Outlook, Teams, and SharePoint is a plus.
• Independent and self-driven: strong problem-solving skills, time-management skills, and organizational skills, with high attention to detail.
• Minimum of a BA or BS in science, engineering, or medical field; advanced degree strongly preferred.
• Entry-level position (0-2 years medical writing/industry experience).
• Strong command of medical and surgical terminology.
• Oral and written fluency in English is required.
Location and Travel:
• Position is fully remote. Employees are expected to have an appropriate remote working environment.
Note: This job description is a summary of the job and requirements that are essential to the position. Global reserves the right to modify, interpret, or apply this job description as appropriate. This job description does not imply that these are the only duties to be performed by the person in this position. This job description is not an employment contract.
3 openings. Telecommuting is allowed.
About Global Regulatory Writing and Consulting
Who We Are: We are GLOBAL, an exciting young CRO with grit, stamina, and the determination to be the best regulatory writers and consultants in the biotech, pharma, and medical device fields. Together, we have built a company culture that delivers true work/life balance. We strive to provide unrivaled internal team support to allow our employees flexible schedules and a freelance lifestyle. Personal and professional development are of great importance to us, we invest in our employees and promote from within. Most importantly, we take care of our people with the best benefits available on the market, including 100% coverage of medical insurance premiums for the employee and 75% of dependents, flexible PTO, quarterly bonuses, impressive retirement savings support, and a profit-sharing plan so we can all grow from GLOBAL’s success. At GLOBAL we approach things differently, outside the box and with teams of experts. Our writers and consultants are specialists in their unique areas of expertise. This allows us to provide boutique-like, plug and play services for impossible-to-fill roles. Our employees are committed to saving lives. They constantly strive to be the best, to go above and... beyond expectations, and to help our clients succeed. Our impact is real, our clients see it every day. We take great pleasure in helping get life-saving drugs and devices into the hands of those who need them most.