What are the responsibilities and job description for the Clinical Evaluation Report Manager position at Olympus Corporation of the Americas?
Workplace Flexibility: Field
For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.
Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.
Our five Core Values empower us to achieve Our Purpose:
Patient Focus, Integrity, Innovation, Impact and Empathy.
Learn more about Life at Olympus.
Job Description
The Clinical Evaluation Manager/Senior Clinical Evaluation Report Writer reports directly to the Regional Lead, Clinical Evaluation Reporting, MSA.
The individual creates CERs in support of EU-MDR regulatory approval strategies across Olympus business unit portfolio and meet timelines according to projects and requirements from regulations and laws.
The individuals have an in-depth knowledge of the EU-MDR 2017/745, EU-MDD 93/42 EEC, MEDDEV 2.7.1 rev 4, and ISO 14971 Risk Management ensuring that clinical evaluation reporting activities are conducted in accordance with regulatory and company standard meeting all timeframes and targets with the highest quality.
The Clinical evaluation manager collaborates with cross-functional teams across Quality Management, Design Assurance, Research and Development, Marketing, Regulatory Affairs, Medical Safety, and within the broader Olympus organization, as appropriate.
The job is conducted in line with our Core Values which are: patient focus, integrity, innovation, impact, and empathy.
Job Duties
- Creation, update and management of Clinical Evaluation Reports (CER), Clinical evaluation plans (CEP), Post-Market Clinical Follow Up Plans (PMCF Plan), Post-Market Clinical Follow Up Reports (PMCF reports), and SSCP (Summary of safety and clinical performance)
- Coordination and review of the CEP, CER, PMCF plan, PMCF report, and SSCP documents as generated by external supplier(s) or Clinical Evaluation Report Writers
- Systematic analysis of clinical evidence related to Olympus products or diagnostic / therapeutic procedures by literature research in relevant data bases (e.g. Pubmed, Embase, Cochrane)
- Close collaboration with Product Management, Risk Management, R&D and Regulatory Affairs to provide input on deliverables, clinical research and literature evidence and support product development process needs
- Planning and initiation of Post-market Clinical Follow-up activities together with Product or Marketing Management and clinical affairs
- Prepare and support audits at OSTA side
- Report directly to Regional Lead CER
- Other duties as assigned
Job Qualifications
Required:
- Master level degree or PhD in health science related field required.
- Minimum of 5 years of experience in CER creating required.
- Minimum of 5 years of business experience in MedTech Industry required.
- Highly self-organized and efficient working style – demonstrated strong communication skills – Team-player
- Strong knowledge of applicable laws and regulations relevant to Clinical Evaluation, e.g. with EU-MDR, EU-MDD, MEDDEV 2.7.1 rev 4, ISO 14971 Risk Management,
- Knowledge of interpretation and analysis of scientific literature
- Proficient English both spoken and written
- Good knowledge of MS Office package
- Has a comfortable remote working environment. Has a stable internet connection for effective productivity. Disciplined to work toward tasks with limited guiding direction.
Why join Olympus?
We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:
Competitive salaries, annual bonus and 401(k)* with company matchComprehensive medical, dental, vision coverage effective on start date
24/7 Employee Assistance Program
Free live and on-demand Wellbeing Programs
Generous Paid Vacation and Sick Time
Paid Parental Leave and Adoption Assistance*
12 Paid Holidays
On-Site Child Daycare, Café, Fitness Center**
Connected Culture you can embrace:
Work-life integrated culture that supports an employee centric mindsetOffers onsite, hybrid and field work environments
Paid volunteering and charitable donation/match programs
Employee Resource Groups
Dedicated Training Resources and Learning & Development Programs
Paid Educational Assistance
US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?
Learn more about our benefit and incentives.
The anticipated base pay range for this full-time position working at this location is $104,061.00 - $145,685.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including: level of experience, working location, and relevant education and certifications.
At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.
You Belong at Olympus
We value a workforce that reflects a wide range of perspectives, backgrounds, and experiences. We foster an environment where all employees feel valued, respected, and supported. And we provide employees with equal access to opportunities for growth and development.
Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).
Let’s realize your potential, together.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs
Salary : $104,061 - $145,685
