Sr Medical Writer - Exempt - LanceSoft Inc
Boulder, CO 80301
About the Job
Must Have:
EU MDR Author of CERs and other Client documents.
This role predominantly focuses on writing, editing and maintaining Clinical Evaluation Plans and Reports (CEP, CER), and Post Market Follow-up (PMCF) Plans and Report, and Periodic Safety Update Reports (PSUR). and responses to Notified Bodies.
• Conducts comprehensive literature searches and performs critical evaluation of clinical evidence (including risk/benefit, State of the Art, etc.) for generation of new/maintenance of existing Clinical Evaluation Reports (CERs) in compliance with the EU Medical Device Regulation, Australia Dept of Health Guidelines, and other geographic regulations as required, or to support product development, risk analysis, regulatory submissions, or due diligence efforts.
• Assesses on an ongoing basis the quality, scientific validity, and audit-readiness of CERs.
• Supports internal and regulatory body audits of clinical materials, including remediation of content as required.
• Analyzes clinical evidence of all kinds (e.g., public, proprietary, published, unpublished) from all sources (e.g., journals, internal documents, regulatory submissions) to assist project proposals and departmental strategies, understanding the levels of evidence required to achieve Regulatory, Marketing, and other departmental goals
HM's Top 3:
This individual should have 2- 5 years or close to that experience authoring/executing Clinical Evaluation Reports, Clinical Evaluation Plans, and PMCF Plan or Reports.
Must have MDR experience with Clinical Evaluation Report writing experience
High degree of project management, excellent communication, and initiative. Experience with ReadCube is nice to have.
Education Required: Bachelor's degree required; Strongly preferred to have Masters or PhD degree(s) in biomedical sciences or technical disciplines
Years’ Experience Required: Minimum of 4 years medical or clinical writing experience which includes (2 years scientific writing for EU MDR, this includes Clinical Evaluation Reports (CERs) Clinical Evaluation Plans (CEPs), PMCF Plans, and or reports).
40 hours per week
Remote
Responsibilities may include the following and other duties may be assigned.
Review and summarize scientific literature.
Reports instances of complaints/adverse events from literature to GCH.
Create responses for audit/submission queries.
Maintains database of peer-reviewed literature.
Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
Develop state of the art on product family for its intended purpose.
Create & maintain plans and reports for regulatory authorities.
Review/approve other documentation for device development.
Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Responsibilities may include the following and other duties may be assigned. Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for incompany use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Compiles, analyzes, and summarizes additional data from other sources as needed. Prepares literature for new products, and revises existing literature. Writes and maintains files on informative journal abstracts according to current or estimated future needs. Composes medical papers from outlines provided by doctors for presentations. May prepare responses regarding company products, drugs, or diseases and refers indepth technical inquiries to medical personnel. Requires knowledge of product areas, current developments, and keeping abreast of current literature. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
EU MDR Author of CERs and other Client documents.
This role predominantly focuses on writing, editing and maintaining Clinical Evaluation Plans and Reports (CEP, CER), and Post Market Follow-up (PMCF) Plans and Report, and Periodic Safety Update Reports (PSUR). and responses to Notified Bodies.
• Conducts comprehensive literature searches and performs critical evaluation of clinical evidence (including risk/benefit, State of the Art, etc.) for generation of new/maintenance of existing Clinical Evaluation Reports (CERs) in compliance with the EU Medical Device Regulation, Australia Dept of Health Guidelines, and other geographic regulations as required, or to support product development, risk analysis, regulatory submissions, or due diligence efforts.
• Assesses on an ongoing basis the quality, scientific validity, and audit-readiness of CERs.
• Supports internal and regulatory body audits of clinical materials, including remediation of content as required.
• Analyzes clinical evidence of all kinds (e.g., public, proprietary, published, unpublished) from all sources (e.g., journals, internal documents, regulatory submissions) to assist project proposals and departmental strategies, understanding the levels of evidence required to achieve Regulatory, Marketing, and other departmental goals
HM's Top 3:
This individual should have 2- 5 years or close to that experience authoring/executing Clinical Evaluation Reports, Clinical Evaluation Plans, and PMCF Plan or Reports.
Must have MDR experience with Clinical Evaluation Report writing experience
High degree of project management, excellent communication, and initiative. Experience with ReadCube is nice to have.
Education Required: Bachelor's degree required; Strongly preferred to have Masters or PhD degree(s) in biomedical sciences or technical disciplines
Years’ Experience Required: Minimum of 4 years medical or clinical writing experience which includes (2 years scientific writing for EU MDR, this includes Clinical Evaluation Reports (CERs) Clinical Evaluation Plans (CEPs), PMCF Plans, and or reports).
40 hours per week
Remote
Responsibilities may include the following and other duties may be assigned.
Review and summarize scientific literature.
Reports instances of complaints/adverse events from literature to GCH.
Create responses for audit/submission queries.
Maintains database of peer-reviewed literature.
Appraise, analyze, summarize, and discuss clinical evidence from all the available sources.
Conducts comprehensive literature searches and performs a critical evaluation of clinical evidence.
Develop state of the art on product family for its intended purpose.
Create & maintain plans and reports for regulatory authorities.
Review/approve other documentation for device development.
Knowledge of regulatory agencies’ guidelines on clinical evaluation requirements.
SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor.
Works independently under limited supervision to determine and develop approach to solutions.
Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area.
Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
Makes improvements of processes, systems or products to enhance performance of the job area.
Analysis provided is in-depth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors.
Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.
May manage projects, requiring delegation of work and review of others' work product.
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
May have practical knowledge of project management.
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Responsibilities may include the following and other duties may be assigned. Writes and edits manuscripts on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for incompany use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. Compiles, analyzes, and summarizes additional data from other sources as needed. Prepares literature for new products, and revises existing literature. Writes and maintains files on informative journal abstracts according to current or estimated future needs. Composes medical papers from outlines provided by doctors for presentations. May prepare responses regarding company products, drugs, or diseases and refers indepth technical inquiries to medical personnel. Requires knowledge of product areas, current developments, and keeping abreast of current literature. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
Source : LanceSoft Inc
