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MEDICAL WRITER 2

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  • ID: 491259
  • Posted: 10/8/2021
  • Location: Sunnyvale, CA
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 9 - 12 Months

Description

Acara Solutions is looking for a MEDICAL WRITER for our Client located in Sunnyvale, CA.
  • This position reports to Manager, Clinical Affairs, (Clinical Evaluation) and requires a strong candidate with experience in medical writing of clinical regulatory documents.
  • The position will mainly focus on development of Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents.
  • The purpose of this job is to author and develop clinical evaluation reports (CERs) per MEDDEV 2.7.1 Rev 4, to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance.
  • Authoring Clinical documentation mainly the Clinical Evaluation Reports [CER] including clinical section of regulatory authority requests.
  • Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
  • Participates in and performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends.
  • Providing product guidance to the clinical librarian to help with conducting literature searches on products/product families.
  • Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
  • Critically appraise scientific literature and write clinical summaries for products and surgical procedures
  • Managing CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.
  • Serve as a functional representative for R&D development activities (e.g., Product or Technology Development Process teams) and will support broader Clinical/Medical Affairs activities such as Regulatory submissions/responses.
  • Interacting with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation reports for new products requiring CE Mark.
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
  • Perform periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
  • Provide clinical perspective and support to guide new product development for CE Mark purposes. May require ongoing core team support (e.g., weekly meetings) or periodic, as needed participation and input.
  • May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on Intuitive clinical trials.
  • May author Protocols and/or routine Clinical Study Progress Reports.
  • Ensure compliance with corporate (e.g., SOP"s) and regulatory requirements (e.g., GCP and US and OUS guidelines)
 
Pay and Benefits:
The salary for this position is $2.00 and $53.14 per hour (Max Pay rate).
 
Job Requirements

 
Required Skills / Qualifications:
  • High school or GED
  • Minimum of 2 years" experience in Medical writing
  • Minimum of 2 years" experience in Clinical evaluation report writing in a medical device industry
Preferred Skills / Qualifications:
  • Competency Requirements: (Competency is based on: education, training, skills and experience.)In order to adequately perform the responsibilities of this position the individual
  • Previous experience in the application of therapeutic and device knowledge to development of clinical evaluation reports.
  • Ability to identify critical information needs and identify roles / individuals to involve for decision making within clinical evaluation assessment and report development.
  • Strong experience in conducting literature searches, reviews and appraisal of the scientific data.
  • To clearly and effectively communicate verbally and in technical or scientific writing; effective scientific writing skills.
  • Excellent critical and analytical thinking skills.
  • MD, PhD or M.S. degree in scientific.
  • High level of attention to detail and accuracy.
  • To work effectively on cross-functional teams.
  • To manage multiple projects across numerous surgical disciplines.
  • Communication, presentation and interpersonal skills with high attention to detail and organization.
  • Experience in protocol development, writing clinical section for regulatory submission and clinical evaluation report writing.
  • Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude)
  • Consistently shows dedication or strong work-ethic to help meet aggressive timelines or multiple projects when necessary
  • We are an AA/EEO/Veterans/Disabled employer.
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen.


Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron's strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.
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