What are the responsibilities and job description for the Medical Writer (Must Have EU MDR) position at MillenniumSoft Inc?
Position : Medical Writer (Must Have EU MDR)
Location : Franklin Lakes, NJ
Duration : 12 Months Contract
Total Hours/week : 40.00
Description
Location : Franklin Lakes, NJ
Duration : 12 Months Contract
Total Hours/week : 40.00
Description
- The Medical Writer in client Medical Pharmaceutical Systems Medical Affairs is responsible for the generation and development of documents relating to Clinical and Human Factors assessments, evaluations and post market surveillance summaries.
- Within this role, the Medical Writer will write and update Clinical Development Plans, Human Factor Engineering (HFE) Reports and other associated clinical and Human Factors (HF) documents.
- The medical writer is a pivotal role to ensure compliance with associated regulations and pivotal in ensuring that there is available evidence to support the safety and performance of the products designed, produced and manufactured by the company.
- The Medical Writer will perform and document systematic literature reviews, critically evaluate identified data, and will interface with various members of the Medical Affairs team and with cross-functional team members in order to achieve high-quality clinical and Human Factors documents.
- The Medical Writer is also responsible for the development or review of study-related documents, including Clinical and Human Factors study executive summaries and related power point presentations.
- The Medical Writer will be an integral part of the global Medical Affairs team and will collaborate with Medical Affairs leaders, Clinical and HF program leaders, Clinical and HF specialists and other key associates.
- The Medical Writer is also responsible for optimizing processes for clinical evaluation and investigation as they relate to medical writing.
- This role requires great familiarity and application of the associated regulations and guidance, including MDR (2017/745), MDD, MEDDEV 2.7.1 Rev. 4 and other MEDDEV guidances, ISO 14155, 21 CFR 812.
- This role will report to the Associate Director, Medical Affairs in Franklin Lakes, NJ.
- Create and update Clinical Development Plans in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR.
- Contribute to the Summary of Safety and Clinical Performance in alignment with EU MDR.
- Perform 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 any ad hoc reports required.
- Develop and manage CER project plans and timelines.
- Serve as a subject matter expert on clinical aspects of Technical documentation.
- Analyze available clinical evidence (data held by the manufacturer, published literature) to assist the Medical Affairs team with clinical development strategy.
- Write and or edit clinical documentation, including but not limited to clinical development plans, HFE reports, Health Hazard Evaluations. Ensure high quality study documentation that is submission-ready for various regulatory agency and external distribution.
- Support periodic and ad hoc assessments of device safety and efficacy in support of post-market surveillance and risk management objectives.
- Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer-reviewed medical journals or congresses.
- Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission.
- Write and/or contribute to abstracts and submissions of clinical and HF data to various medical device congresses or symposia.
- Work with Medical Affairs and cross functional associates to ensure high quality submissions and data integrity.
- Contribute to the development and optimization of Medical Affairs SOPs.
- Support and assist Medical Affairs team members in the generation of effective visual and written communication.
- Required Knowledge, Skills and Abilities
- 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.
- Proven experience performing literature reviews, analyzing data and communicating outputs. Experience working within a medical device or pharmaceutical organization in a Research & Development, Scientific and Medical Affairs, Clinical or Regulatory role.
- 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 guidances, including 2.7/1 Revision 4 and 2.12/2 Revision 2, ISO 14155, ICH guidance including E3 CSR, E6 (R2) GCP, and familiarity regulations/ guideline relating to Risk management (i.e. ISO 13485 and ISO 14971). Familiarity with FDA guidance documents related to Human Factors Engineering.
- Demonstrated ability to work independently and as part of a team.
- Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
- Ability to work with a minimum of supervision.
- Ability to work in a team environment.
- Advanced skills using Microsoft Office products such as Outlook, Word, Excel and PowerPoint.
- Bachelors in a relevant discipline required. Master's degree or PhD preferred
- 3 years of experience as a medical writer
- 3 years direct experience working on clinical evaluations within the Medical Device industry.
- Medical writing certification a plus
- literature search engines PubMed, Embase: 1 year (Required)
- ISO 13485 and ISO 14971: 1 year (Required)
- EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance: 1 year (Preferred)