Clinical Evaluation Report Writer / Medical Writer

Olympus Corporation of the Americas; United States; Remote; USD 85,000 - 116,000; Full time

Job summary

A leading medical technology company is seeking a Clinical Evaluation Report Writer to support regulatory approval strategies. This role involves creating and managing clinical evaluation reports, requiring strong knowledge of EU regulations and excellent communication skills. The position offers workplace flexibility and a comprehensive benefits package, including competitive salaries and a supportive work culture.

Benefits

Competitive salaries

Annual bonus

401(k) with company match

Employee Assistance Program

Paid Vacation and Sick Time

Paid Parental Leave

On-Site Child Daycare

Fitness Center

Qualifications

• 3-5 years experience in CER creation required.
• Strong knowledge of EU-MDR and related regulations.

Responsibilities

• Create and manage Clinical Evaluation Reports and related documents.
• Conduct systematic analysis of clinical evidence.

Skills

Communication

Team-player

Self-organization

Education

Master level degree

PhD in health science

Tools

MS Office

Job description

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Clinical Evaluation Report Writer / Medical Writer

Working Location:NATIONWIDE

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 ofpatient care so people everywhere can fulfill their desires, dreams, and lives.

Our fiveCore Valuesempower us to achieve Our Purpose:

Patient Focus, Integrity, Innovation, Impact and Empathy.

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.

This role requires 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 job is conducted in line with our Core Values which are: patient focus, integrity, innovation, impact, and empathy.

Job Duties

• Create, update and manage the 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)
• 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)
• Plan and initiate the Post-market Clinical Follow-up activities together with Product or Marketing Management and Clinical Affairs
• Prepare and support audits at OSTA side
• Other duties as assigned

Job Qualifications

Required:

• Master level degree or PhD in health science related field required.
• Minimum of 3-5 years of experience in CER creating required.
• Minimum of 3-5 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 an efficient remote working environment with a stable internet connection for effective productivity.
• Disciplined to work toward tasks with limited guiding direction.

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 match

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 mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation/match programs

Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

The anticipated base pay range for this full-time position working at this location is$85,267.00-$115,110.00/ 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 positionincluding: level of experience, working location, and relevanteducation 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 [e-mail]. 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