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Senior Clinical Evaluation Writer Jobs (NOW HIRING)

... evaluation reports, clinical study reports, and responses to regulatory questions * Lead or ... Excellent written and verbal communication skills, including experience writing clinical study ...

We lead preclinical evaluation strategies, design validation and human factors activities, and ... writing. * Experience working with healthcare providers in a hospital environment * Ability to ...

Primary Function of Position This position reports to Manger/Sr. Manager, Medical Sciences and ... Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry ...

Primary Function of Position This position reports to Manger/Sr. Manager, Medical Sciences and ... Minimum of 2-4 years of experience in clinical evaluation report writing in medical device industry ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based ... Author and maintain Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-Up (PMCF ...

Senior Clinical Liaison

Rockwall, TX · On-site

$60K - $81K/yr

The Senior Clinical Liaison is responsible for evaluating patients and determining if they meet ... Effective written and verbal communication skills. * Ability to prioritize, meet deadlines, and ...

New

Medical Writer IV

Abbott, TX · On-site +1

$65 - $68/hr

The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are ...

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Senior Clinical Evaluation Writer information

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$30.5K

$92.6K

$171K

How much do senior clinical evaluation writer jobs pay per year?

As of Sep 6, 2026, the average yearly pay for senior clinical evaluation writer in the United States is $92,559.00, according to ZipRecruiter salary data. Most workers in this role earn between $71,000.00 and $101,000.00 per year, depending on experience, location, and employer.

What is a senior clinical evaluation writer?

Senior Clinical Evaluation Writers are experienced professionals who create and manage clinical evaluation reports (CERs) and related documentation for medical devices, ensuring compliance with regulatory standards such as the EU Medical Device Regulation (MDR). They analyze clinical data, review scientific literature, and collaborate with cross-functional teams to demonstrate the safety and performance of medical devices. Their expertise helps companies navigate complex regulatory requirements and support product approvals in global markets.

How does a senior clinical evaluation writer typically collaborate with cross-functional teams during the clinical evaluation process?

A Senior Clinical Evaluation Writer works closely with regulatory affairs, clinical, and medical teams to gather and interpret data for clinical evaluation reports. Regular collaboration ensures that the documentation meets regulatory standards and accurately reflects the device’s safety and performance. The writer often leads meetings to clarify data requirements, address feedback, and integrate input from various stakeholders, making strong communication and teamwork skills essential for success in this role.

What are the key skills and qualifications needed to thrive as a senior clinical evaluation writer, and why are they important?

To thrive as a Senior Clinical Evaluation Writer, you need expertise in clinical research, regulatory requirements for medical devices (such as MDR/IVDR), and a background in life sciences or medicine. Familiarity with literature review tools, systematic review software, and regulatory databases, as well as experience with CER templates and guidance documents, is typically required. Strong analytical thinking, attention to detail, and effective written communication are critical soft skills for success in this role. These skills and qualifications ensure high-quality, compliant clinical evaluation reports that support product safety and market approval.

What is the difference between Senior Clinical Evaluation Writer vs Clinical Evaluation Specialist?

AspectSenior Clinical Evaluation WriterClinical Evaluation Specialist
CredentialsTypically requires advanced degrees (e.g., Master’s or PhD) and experience in medical writing or regulatory affairsOften holds similar degrees and certifications, with a focus on clinical data analysis and regulatory knowledge
Work EnvironmentWorks primarily on writing and reviewing clinical evaluation reports, often independently or leading teamsFocuses on data collection, analysis, and supporting report development within clinical or regulatory teams
Industry UsageCommonly used in medical device and pharmaceutical industries for regulatory submissionsUsed in clinical research, medical device, and pharmaceutical sectors for compliance and evaluation activities

The main difference is that a Senior Clinical Evaluation Writer primarily focuses on authoring and reviewing clinical evaluation reports, often with leadership responsibilities, while a Clinical Evaluation Specialist concentrates on data analysis and supporting report development within clinical and regulatory teams. Both roles require strong regulatory knowledge and clinical expertise, but their day-to-day tasks and focus areas differ.

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Infographic showing various Senior Clinical Evaluation Writer job openings in the United States as of August 2026, with employment types broken down into 3% As Needed, 71% Full Time, 18% Part Time, and 8% Contract. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution, with an average salary of $92,559 per year, or $44.5 per hour.

Senior Clinical Scientist

Whoop

Boston, MA • On-site

Full-time

Posted 16 days ago


Job description

WHOOP is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.
As a Senior Clinical Scientist, you will independently own assigned clinical studies that support WHOOP's clinical development, product innovation, and regulatory objectives. Operating with minimal oversight, you will translate clinical and product questions into rigorous research approaches, generate and interpret evidence from clinical, wearable, and real-world data, and communicate findings in a way that informs product decisions, regulatory strategy, and clinical evidence generation. This role requires someone who can lead their assigned workstreams, partner effectively across cross-functional teams.
RESPONSIBILITIES:
  • Independently lead the design and development of clinical study protocols, evidence-generation plans, endpoints, study procedures, and statistical analysis approaches with minimal oversight. Ensure studies are scientifically rigorous and aligned with clinical, product, and regulatory objectives
  • Support and oversee key aspects of study execution, including feasibility assessment, study startup, data collection, data review, monitoring oversight, and study closeout. Partner with Clinical Operations, Data Management, and external vendors or sites as needed to ensure high-quality execution
  • Use statistical tools such as R, SAS, Python, Stata, or similar platforms to analyze clinical, wearable, and real-world datasets. Interpret results, identify trends and limitations, and generate actionable insights that support clinical, regulatory, and product decision-making
  • Conduct comprehensive literature reviews to inform study design, endpoint selection, statistical methodologies, product claims, regulatory strategy, and scientific positioning. Integrate external scientific evidence with WHOOP data to support clinical development goals
  • Ensure the accuracy, integrity, and quality of clinical data by implementing and reviewing appropriate quality control measures throughout the study lifecycle. Conduct quality checks on datasets, statistical outputs, tables, figures, listings, and scientific conclusions
  • Communicate complex clinical and statistical findings in clear, actionable terms to clinical, product, data science, regulatory, and executive stakeholders. Translate technical analyses into meaningful business, product, and clinical insights
  • Independently author and review clinical study reports, protocols, statistical analysis plans, literature reviews, clinical evidence summaries, regulatory submission sections, manuscripts, abstracts, and internal scientific memos. Ensure documentation is accurate, scientifically sound, and regulatory-compliant
  • CWork closely with Product, Data Science, Engineering, Clinical Operations, Regulatory Affairs, Quality, and Legal teams to ensure clinical and scientific input is incorporated throughout the product lifecycle
  • Contribute to evidence-generation strategies and clinical documentation for regulatory submissions, including 510(k), De Novo, CE Mark, clinical evaluation reports, clinical study reports, and responses to regulatory questions
  • Lead or contribute to manuscripts, abstracts, posters, presentations, and other scientific communications for internal stakeholders, scientific conferences, peer-reviewed journals, and external collaborators

QUALIFICATIONS:
  • Advanced degree preferred in Life Sciences, Clinical Research, Public Health, Epidemiology, Biostatistics, Biomedical Engineering, Medicine, or a related field. Master's, PhD, MD, PharmD, MPH, or equivalent experience strongly preferred
  • 6-9 years of experience in clinical research, clinical science, data analysis, epidemiology, medical device, digital health, SaMD, pharmaceutical, biotech, or real-world evidence settings
  • Demonstrated ability to independently design and lead clinical studies, including protocol development, endpoint selection, study methodology, statistical analysis planning, and clinical study report writing
  • Strong understanding of FDA regulations, ICH-GCP, ISO 14155, clinical trial design, and evidence-generation requirements for regulated or health-related products
  • Experience contributing to regulatory submissions or clinical evidence packages, such as 510(k), De Novo, CE Mark, clinical evaluation reports, clinical study reports, or related documentation
  • Proficiency in statistical software such as R, SAS, Python, Stata, or similar tools
  • Strong analytical and problem-solving skills, with the ability to interpret complex datasets and clearly explain findings, limitations, and implications
  • Excellent written and verbal communication skills, including experience writing clinical study reports, regulatory documents, scientific manuscripts, abstracts, presentations, or internal research summaries
  • Ability to independently manage complex work streams, prioritize effectively, and deliver high-quality work in a fast-paced environment with minimal oversight
  • Nice to have: Experience working with clinical data, wearable data, real-world data, observational datasets, or large-scale health datasets
  • Nice to have: Experience with software as a medical device, digital biomarkers, wearable sensors, remote patient monitoring, or consumer health technology
  • Nice to have: Experience with Snowflake or other large-scale data platforms
  • Nice to have: Familiarity with software validation, algorithm validation, and clinical performance evaluation for digital health or SaMD products

This role is based in the WHOOP office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.
Interested in the role, but don't meet every qualification? We encourage you to still apply! At WHOOP, we believe there is much more to a candidate than what is written on paper, and we value character as much as experience. As we continue to build a diverse and inclusive environment, we encourage anyone who is interested in this role to apply.
WHOOP is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
The WHOOP compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.
At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
The U.S. base salary range for this full-time position is $145,000 - $195,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.
In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.
These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate's specific qualifications, expertise, and alignment with the role's requirements.

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About Whoop

Sourced by ZipRecruiter

At WHOOP, we're on a mission to unlock human performance. WHOOP empowers users (Olympians, Professional Athletes, Fitness Enthusiasts, etc) to perform at a higher level through a deeper understanding of their bodies and daily lives.

Industry

Fitness and sports centers

Company size

501 - 1,000 Employees

Headquarters location

Boston, MA, US

Year founded

2012