Principal Medical WriterProject Manager, Clinical Evaluation
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Job Location:
Maple Grove, MN - USA
Monthly Salary:
$ 99300 - 198700
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Job Description
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with high employer contribution
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.
For years Abbotts medical device businesses have offered technologies that are faster more effective and less invasive. Whether its glucose monitoring system innovative therapies for treating heart disease or products that help people with chronic pain or movement disorders our medical device technologies are designed to help people live their lives better and healthier. Every day our technologies help more than10000 peoplehave healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than500000 peoplewith diabetes from routine fingersticks.
The Opportunity
We have an opportunity for aClinical Evaluation - Principal Project Manager. This new team member will combine understanding of scientific and research methodology medical device regulations and guidelines and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4 MDD AIMDD MDCG Guidance documents and EU MDR 2017/745. This role will support the Structural Heart and Vascular product lines.
What Youll Work On
Manage provide guidance and oversight of CER Medical Writers development of Clinical Evaluation Reports and associated documents; set deliverable and project timelines and ensure timelines are met.
Facilitate communication and exchange of documents between stakeholders (e.g. internal personnel such as Regulatory Affairs R&D Engineering Clinical Engineering A&P and Marketing Library Services Quality Engineering Post-market Surveillance Group Clinical Affairs Risk Management Program Management as well as external vendors such as CROs Medical Writers and Physician Reviewers).
Review edit and write portions as needed of Clinical Evaluation Reports and associated documents.
Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions.
Provide strategic guidance on regulatory requirements pertaining to clinical data and clinical evaluations to new product development teams and sustaining teams.
Compliance with applicable corporate and divisional policies and procedures.
Participate in and support internal and external audits and responses to audit findings as appropriate in root cause analysis preventive or corrective actions effectiveness monitoring and other quality metrics.
Develop and update new policies as appropriate for processes and procedures relating to the clinical evaluation process and train key personnel on them.
Function independently as a decision-maker on CER-related regulatory issues.
Execute projects within budgetary guidelines.
Required Qualifications
Associates Degree( 13 years)
Minimum 7years experience
PreferredQualifications
Bachelors Degree in Scientific or Engineering related area.
Advanced degree
Scientific/research background; training and degree in science engineering or medical fields; understanding of research design methodology and statistics.
Thorough understanding of the EU MDR 2017/745 MDD 93/42/EEC; AIMDD 90/385/EEC; MEDDEV 2.7/1 Rev 4 MDCGGuidanceson clinical evaluations SSCP PMCF plans and reports and other international harmonized standards and guidelines related to medical devices clinical studies and quality systems.
Project management and/or management ofpeopleexperience.
Strong presentation skills in relevant areas of clinical/technical applications.
Strong command of medical and surgical terminology.
Demonstrated ability toidentifyand adapt to shifting priorities and competing demands.
Highly developed interpersonal skills and strong attention to detail.
5-7 years of experience in clinical research clinical affairs regulatory affairs or quality systems in the medical device or pharmaceuticals industry.
3-5 years of experience writing reviewing or leading development of CERs and related documentsin accordance withMEDDEV 2.7/1 Rev 3 and 4 the medical device directives (MDD 93/42/EEC; AIMDD 90/385/EEC) and the EU MDR 2017/745.
Certification is a plus (e.g. RAC and PMP).
The base pay for this position is
$99300.00 $198700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Medical Writing
DIVISION:
MD Medical Devices
LOCATION:
United States > Maple Grove : 6820 Wedgwood Road N.
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
