Clinical Scientist
Newark, DE ยท Remote
Experience in CER/CEP writing, literature review, and regulatory documentation. * Strong analytical, technical writing, and cross-functional collaboration skills. Preferred: * 2-4 years of CER ...
Newark, DE ยท Remote
Experience in CER/CEP writing, literature review, and regulatory documentation. * Strong analytical, technical writing, and cross-functional collaboration skills. Preferred: * 2-4 years of CER ...
Newark, DE ยท Remote
Experience in CER/CEP writing, literature review, and regulatory documentation. * Strong analytical, technical writing, and cross-functional collaboration skills. Preferred: * 2-4 years of CER ...
Los Angeles, CA ยท Remote
Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role. The ideal candidate is looking to build their medical writing career ...
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Los Angeles, CA ยท Remote
Please note that previous PER or CER writing experience and management of medical regulatory writers is required for this role. The ideal candidate is looking to build their medical writing career ...
Raleigh, NC ยท On-site
$14.75 - $18.75/hr
Reporting to the Director of C-CER, the Summer Student Assistant is for Undergraduate students ... Must have strong verbal and written communication and organizational skills; proven ability to ...
Raleigh, NC ยท On-site
$14.75 - $18.75/hr
Reporting to the Director of C-CER, the Summer Student Assistant is for Undergraduate students ... Must have strong verbal and written communication and organizational skills; proven ability to ...
Raleigh, NC ยท On-site
$14.75 - $18.75/hr
Reporting to the Director of C-CER, the Summer Student Assistant is for Undergraduate students ... Must have strong verbal and written communication and organizational skills; proven ability to ...
Raleigh, NC ยท On-site
$14.75 - $18.75/hr
Reporting to the Director of C-CER, the Summer Student Assistant is for Undergraduate students ... Must have strong verbal and written communication and organizational skills; proven ability to ...
Maple Grove, MN ยท On-site
CER (Clinical Evaluation Review/Report) Writing * MDR (Medical Device Regulations) * EU (European Union) * Literature Review (e.g., PubMed) Responsibilities: * Write and review scientific manuscripts ...
Maple Grove, MN ยท On-site
CER (Clinical Evaluation Review/Report) Writing * MDR (Medical Device Regulations) * EU (European Union) * Literature Review (e.g., PubMed) Responsibilities: * Write and review scientific manuscripts ...
Saint Paul, MN ยท On-site
$50 - $55/hr
Clinical Evaluation experience (end-to-end CER development) * 4+ years (or 2+ with advanced degree) in clinical research/evaluation/evidence * Strong experience in medical writing & regulatory ...
Saint Paul, MN ยท On-site
$50 - $55/hr
Clinical Evaluation experience (end-to-end CER development) * 4+ years (or 2+ with advanced degree) in clinical research/evaluation/evidence * Strong experience in medical writing & regulatory ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
The Sr. Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic ... Collaborates with team members and stakeholders in planning for and supporting CER related projects ...
Lewisville, TX ยท On-site
... the CER and other sources, including the part for lay persons; write and update CEPs and PMCF plans; work collaboratively with cross-functional partners; prepare answers to Notified Body or ...
Lewisville, TX ยท On-site
... the CER and other sources, including the part for lay persons; write and update CEPs and PMCF plans; work collaboratively with cross-functional partners; prepare answers to Notified Body or ...
... the CER and other sources, including the part for lay persons; write and update CEPs and PMCF plans; work collaboratively with cross-functional partners; prepare answers to Notified Body or ...
... the CER and other sources, including the part for lay persons; write and update CEPs and PMCF plans; work collaboratively with cross-functional partners; prepare answers to Notified Body or ...
Evansville, IN ยท On-site
SERVICE WRITER Reports To: Service Manager Summary The primary function of the Service Writer is ensure customers are greeted openly and friendly and to provide extra mile customer service. The ...
Evansville, IN ยท On-site
SERVICE WRITER Reports To: Service Manager Summary The primary function of the Service Writer is ensure customers are greeted openly and friendly and to provide extra mile customer service. The ...
Warsaw, IN ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... Verbal and written communication skills Proven ability to multi-task Effective time management ...
Warsaw, IN ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... Verbal and written communication skills Proven ability to multi-task Effective time management ...
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... writing and presentation skills Additional Information Sweta 732-549- 5907
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... writing and presentation skills Additional Information Sweta 732-549- 5907
Develop and manage CER project plans and timelines. * Serve as a subject matter expert on clinical ... Write and or edit clinical documentation, including but not limited to clinical development plans ...
Develop and manage CER project plans and timelines. * Serve as a subject matter expert on clinical ... Write and or edit clinical documentation, including but not limited to clinical development plans ...
Develop and manage CER project plans and timelines. * Serve as a subject matter expert on clinical ... Write and or edit clinical documentation, including but not limited to clinical development plans ...
Develop and manage CER project plans and timelines. * Serve as a subject matter expert on clinical ... Write and or edit clinical documentation, including but not limited to clinical development plans ...
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... Verbal and written communication skills Proven ability to multi-task Effective time management ...
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... Verbal and written communication skills Proven ability to multi-task Effective time management ...
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... writing and presentation skills
Raynham, MA ยท On-site
This may entail scheduling CER Review meetings, tracking CER timelines, vendor management, and ... writing and presentation skills
Convert proposal package (CER-LT) to Supply Agreement/approval (CER) after customer acceptance ... Excellent written and verbal communication and presentation skills, including presentation planning ...
Convert proposal package (CER-LT) to Supply Agreement/approval (CER) after customer acceptance ... Excellent written and verbal communication and presentation skills, including presentation planning ...
Ann Arbor, MI ยท On-site
$25.80/hr
... CER) within first year of employment and recertify as applicable; * Be able to understand and follow oral and written instructions; * Be able to work independently and to set priorities to meet ...
Ann Arbor, MI ยท On-site
$25.80/hr
... CER) within first year of employment and recertify as applicable; * Be able to understand and follow oral and written instructions; * Be able to work independently and to set priorities to meet ...
$14.18 - $18.16
3% of jobs
$18.16 - $22.14
9% of jobs
$26.03 is the 25th percentile. Wages below this are outliers.
$22.14 - $26.11
13% of jobs
$26.11 - $30.09
7% of jobs
$30.09 - $34.07
8% of jobs
$34.07 - $38.05
5% of jobs
The median wage is $39.79 / hr.
$38.05 - $42.02
8% of jobs
$42.02 - $46
16% of jobs
$47.54 is the 75th percentile. Wages above this are outliers.
$46 - $49.98
12% of jobs
$49.98 - $53.96
7% of jobs
$53.96 - $57.93
11% of jobs
$14
$38
$57
One of the most common challenges for CER Writers is gathering and interpreting comprehensive clinical data from various sources while ensuring compliance with ever-evolving regulatory requirements. The role often involves collaborating with clinical, regulatory, and product development teams to fill information gaps and clarify technical details. Additionally, managing tight deadlines and adapting to changes in regulatory expectations can create pressure. However, strong organization and communication skills can help CER Writers overcome these challenges and deliver accurate, timely reports that are critical for medical device approval and market access.
To thrive as a CER Writer, you need a strong background in scientific writing, clinical research, and regulatory compliance, often supported by a degree in life sciences or pharmacy. Familiarity with relevant guidelines such as MEDDEV 2.7/1 and proficiency with literature databases and referencing tools like EndNote are crucial. Attention to detail, critical thinking, and effective communication are key soft skills for synthesizing data and collaborating with cross-functional teams. These skills ensure the development of high-quality Clinical Evaluation Reports that meet stringent regulatory standards and support product approvals.
A CER (Clinical Evaluation Report) Writer is responsible for preparing detailed reports that assess the safety and performance of medical devices. They analyze clinical data, regulatory requirements, and scientific literature to ensure compliance with regulations like the EU MDR. CER Writers collaborate with regulatory teams, medical experts, and researchers to compile and present findings in a clear and structured manner. Their work is essential for obtaining and maintaining medical device approvals in global markets.

Contractor
Posted 25 days ago
Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.
Job Title: Clinical Scientist - Medical Devices
Location: Newark, DE
Long Term Contract
Role:
Clinical Scientist responsible for developing Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) to support CE Mark regulatory submissions for medical devices.
Key Responsibilities:
Required Qualifications:
Preferred:
All your information will be kept confidential according to EEO guidelines.
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Human resources consulting services
51 - 200 Employees
Naples, FL, US
2012