The CER Senior Associate Writer is responsible for creating regulatory submission documents related to Clinical Evaluation Reports (CERs). This position includes client interaction and responsibilities for mentoring and supervising the work of CER Associate Writers. The CER Senior Associate Writer may be an employee (full- or part-time) or a consultant (temporary role).
Responsibilities of the Senior Associate:
Tasks may include but are not limited to:
Independently writes, edits, reviews, and formats documents that conform to client-based regulatory submission guidelines and internal document standards (Clinical Evaluation Reports [CER], 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 deadlines.
Coordinates content development with multi-discipline subject matter experts, both internal and external to Global.
Attends meetings about document(s) in development and provides both internal and external management, team, and reviewers with timelines and document status reports as needed.
Provides mentoring and training for CER Associate Writers.
Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.
Responsibilities of the CER Senior Associate Writer:
Tasks may include but are not limited to:
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 (Clinical Evaluation Reports [CER], 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:
Performs article screening in accordance with established inclusion/exclusion criteria.
Performs appraisal of clinical data.
Summarizes relevant medical articles for the State of the Art and Clinical Literature sections of the CER.
Performs searches on the MAUDE database for study and/or comparator devices.
Reviews raw post-market surveillance data and creates tables and summaries.
Contributes to writing sections of the CEP, CER, PMCF, and SSCP, as needed.
Attending internal meetings about document(s) in development and providing CER Managers/ CER Senior Associates with document status reports as needed.
Collaborating with other CER Team members to ensure continuous improvements to writing processes and for professional training.
Skills and Abilities of the CER Senior Associate Writer:
Understanding of EU regulations and guidelines related to medical devices including: MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev. 4; and MDR 2017/745.
Comfortable working in a regulated industry that demands conforming to regulatory requirements and a high level of quality, integrity, and scientific accuracy.
Proficient with Microsoft Office 365. Advanced user of Word (styles, hyperlinking, numbering, etc.) and Excel (using formulas, organizing data, advanced sorting, etc.). Experience using Teams, Outlook, and SharePoint. Experience with referencing software such as EndNote.
Strong understanding of data analysis and statistical methods.
Ability to plan and execute systematic literature reviews (SOA and device-specific): preparing search queries, selecting appropriate search databases and conducting the searches, creating and applying systematic inclusion/exclusion criteria, appraising literature. Experience with literature management tools such as QUOSA or Distiller is a plus.
Vigilance database searching and interpreting results (FDA MAUDE, FDA Recall Database, etc.).
Ability to synthesize complex technical or clinical information/data in a clear, concise, and accurate manner.
Ability to determine the appropriate medium for synthesizing information such as prose, lists, tables, graphics, figures, flow charts, etc.
Independent and self-driven: strong problem-solving skills, timeline management skills, organizational skills, and high attention to detail.
Ability to manage multiple projects and timelines simultaneously.
Experience working with clients or vendors is a plus.
Ability to develop CER strategies.
Requirements for the CER Senior Associate Writer:
Minimum of a BA or BS in science, engineering, or medical field; advanced degree strongly preferred.
1-5 years of medical writing experience in the medical device industry or medical writing.
Oral and written fluency in English is required.
Strong command of medical and surgical terminology.
Experience writing CEPs and all sections of CERs. Experience conducting quality reviews of CEPs and CERs is a plus.
Familiarity with SSCPs, PMS Plans, PMS Reports, PSURs, PMCF Plans, and PMCF Reports.
Location and Travel:
Position is fully remote. Employees are expected to have an appropriate remote working environment.
Occasional travel for team retreats, client-facing meetings, and conferences (<10%).
Internal Number: MD-108, MD-109
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.
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