Itlearn360
Job Overview
The Medical Writer is responsible for the generation and development of documents related to clinical documentations and investigations as applicable.
Job Responsibilities and Essential Duties
Serves as a clinical evaluation lead and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR and MDCG guidance. Contribute to the Summary of Safety and Clinical Performance. (20%)
Serves as point and participates in the Post-Market Clinical Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation. (20%)
Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required. (10%)
Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation. (10%)
Write and/or edit clinical study documentation, including clinical investigational plans/protocols, Investigator’s Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agencies and external distribution. (10%)
Contribute to clinical aspects of Technical documentation. (10%)
Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer‑reviewed medical journals. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. (5%)
Write and/or contribute to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity. (5%)
Contribute to the development and optimization of Clinical Affairs SOPs, as needed. (5%)
Perform other non-routine duties as assigned by the Supervisor. (5%)
Minimum Requirements
Bachelors, Master’s degree or PhD in a relevant scientific discipline, or equivalent.
1-5 years medical writing experience.
Direct experience working on clinical evaluations within the Medical Device industry a plus.
Medical writing certification a plus.
Required Knowledge, Skills and Abilities
Strong interpersonal and communication skills.
Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.
Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions.
Outstanding oral and written communication skills.
Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review/literature management tools a plus.
Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, MDCG guidance documents, ISO 14155, ICH guidance including E3 CSR, E6 GCP, and familiarity regulations/guidelines relating to Risk management (i.e., ISO 13485 and ISO 14971).
Demonstrated ability to work independently and as part of a team.
Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
Advanced skills using Microsoft Office products such as Outlook, Word, Excel and Power Point.
Supervision/Management Of Others
N/A
Internal and External Contacts/Relationships
Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering, Research & Development and Marketing, as needed.
External teams such as CROs, clinical vendors and key opinion leaders, as needed.
Environmental/Safety/Physical Work Conditions
Ensures environmental consciousness and safe practices are exhibited in decisions.
Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
Duties are performed in an office environment.
Travel requirements will vary depending on status of the current projects.
Salary: 110K to 120K annual with 10% STIP
About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge At Getinge, we offer a comprehensive benefits package, which includes:
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tution Reimbursement
Equal Opportunity Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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Job Responsibilities and Essential Duties
Serves as a clinical evaluation lead and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR and MDCG guidance. Contribute to the Summary of Safety and Clinical Performance. (20%)
Serves as point and participates in the Post-Market Clinical Follow-up (PMCF) team. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation. (20%)
Perform comprehensive systematic, documented literature reviews using various search engines in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required. (10%)
Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation. (10%)
Write and/or edit clinical study documentation, including clinical investigational plans/protocols, Investigator’s Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports. Ensure high quality study documentation that is submission-ready for various regulatory agencies and external distribution. (10%)
Contribute to clinical aspects of Technical documentation. (10%)
Write and/or support the development of manuscripts relating to clinical study data or clinical evidence for submission to peer‑reviewed medical journals. Work with medical professionals to ensure alignment with journal requirements for targeted manuscript submission. (5%)
Write and/or contribute to abstracts and submissions of clinical data to various medical congresses or symposia. Work with medical professionals to ensure high quality submissions and data integrity. (5%)
Contribute to the development and optimization of Clinical Affairs SOPs, as needed. (5%)
Perform other non-routine duties as assigned by the Supervisor. (5%)
Minimum Requirements
Bachelors, Master’s degree or PhD in a relevant scientific discipline, or equivalent.
1-5 years medical writing experience.
Direct experience working on clinical evaluations within the Medical Device industry a plus.
Medical writing certification a plus.
Required Knowledge, Skills and Abilities
Strong interpersonal and communication skills.
Excellent project management skills with the ability to deliver projects on timelines that support corporate and departmental goals and objectives.
Strong analytical and organizational skills as well as demonstrated ability to solve problems with innovative solutions.
Outstanding oral and written communication skills.
Proficiency in using and navigating PubMed, Embase and other literature search engines. Experience in DistillerSR, EndNote and other literature review/literature management tools a plus.
Strong working knowledge of regulations and guidance relating to Clinical Affairs, including EU MDR (2017/745), EU MDD (93/42/EEC), MEDDEV guidance, including 2.7/1 Revision 4 and 2.12/2 Revision 2, MDCG guidance documents, ISO 14155, ICH guidance including E3 CSR, E6 GCP, and familiarity regulations/guidelines relating to Risk management (i.e., ISO 13485 and ISO 14971).
Demonstrated ability to work independently and as part of a team.
Ability to prioritize tasks in a fast-paced environment. Ability to work under urgent deadlines and flexibility to accommodate fluctuating timelines.
Advanced skills using Microsoft Office products such as Outlook, Word, Excel and Power Point.
Supervision/Management Of Others
N/A
Internal and External Contacts/Relationships
Internal Getinge teams such as Medical Affairs, Regulatory Affairs, Quality Engineering, Research & Development and Marketing, as needed.
External teams such as CROs, clinical vendors and key opinion leaders, as needed.
Environmental/Safety/Physical Work Conditions
Ensures environmental consciousness and safe practices are exhibited in decisions.
Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
Duties are performed in an office environment.
Travel requirements will vary depending on status of the current projects.
Salary: 110K to 120K annual with 10% STIP
About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge At Getinge, we offer a comprehensive benefits package, which includes:
Health, Dental, and Vision insurance benefits
401k plan with company match
Paid Time Off
Wellness initiative & Health Assistance Resources
Life Insurance
Short and Long Term Disability Benefits
Health and Dependent Care Flexible Spending Accounts
Commuter Benefits
Parental and Caregiver Leave
Tution Reimbursement
Equal Opportunity Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
#J-18808-Ljbffr