ClinChoice
Post-Market Clinical Follow-up (PMCF) Medical Writer Consultant
ClinChoice, Long Island City, New York, United States, 11101
Post-Market Clinical Follow-up (PMCF) Medical Writer Consultant
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.
at ClinChoice (View all jobs)United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Post-Market Clinical Follow-up (PMCF) Medical Writer Consultant for 1 year contract,
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:Responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and ReportsCollaborates with members of cross-functional teams to prepare PMCF plans and reports within projected timelines with minimal supervisionSupport rapid responses to requests for additional information from competent authorities, regulatory agencies, and notified bodiesSupport clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategySupport internal and external auditsComplete training by established due datesProvides documents, data, and feedback to Post-market Surveillance (PMS), Clinical Evaluation Report (CER), and Periodic Safety Update Report (PSUR) management and writers, as well as others such as Risk Management, Medical Affairs, and Medical SafetyMay contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projectsResponsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholdersResponsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and proceduresPerform other duties assigned as neededGenerally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations
Education and Experience:
Minimum of a bachelor’s degree preferably in Life Science, Physical Science, Nursing, or Biological Science requiredAdvanced degree desirable.BS/BA with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferredPrevious experience in clinical research or equivalent is requiredExperience working well with cross-functional teams is requiredExperience managing projects is requiredMedical device experience highly preferredExtensive experience with EU Commission Regulation 2017/745 Medical Device Regulation (MDR) and/or MEDDEV 2.7 highly preferredRelevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...)Clinical/medical background a plusExperience in therapeutic space (breast augmentation and reconstruction) a plus
Specific Role Requirements and Skills:
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, clinical trends, and global clinical trial regulations;Ability to provide scientifically strategic and scientific clinical research input across Life-Cycle Management (LCM) projects;Ability to provide same for New Products a plusProven track record in delivering clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;Strong presentation and technical writing skills;Strong written and oral communication skills;Strong computer skills and competence with use of Microsoft Excel, Word, PowerPoint, and EndNote or other reference management softwareDemonstrate competencies in the following area are required:Behave and lead in a professional and ethical mannerAdvanced technical writing skillsAdvanced project management skills with ability to handle multiple projects
The Application Process:
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:
PMCF , Medical Writer, CRO, Consultant, LCM, New Product, Clinical Writing
#J-18808-Ljbffr
Be one of the first applicants, read the complete overview of the role below, then send your application for consideration.
at ClinChoice (View all jobs)United States
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds....
ClinChoice is searching for a Post-Market Clinical Follow-up (PMCF) Medical Writer Consultant for 1 year contract,
to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
Main Job Tasks and Responsibilities:Responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and ReportsCollaborates with members of cross-functional teams to prepare PMCF plans and reports within projected timelines with minimal supervisionSupport rapid responses to requests for additional information from competent authorities, regulatory agencies, and notified bodiesSupport clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategySupport internal and external auditsComplete training by established due datesProvides documents, data, and feedback to Post-market Surveillance (PMS), Clinical Evaluation Report (CER), and Periodic Safety Update Report (PSUR) management and writers, as well as others such as Risk Management, Medical Affairs, and Medical SafetyMay contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projectsResponsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholdersResponsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and proceduresPerform other duties assigned as neededGenerally manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but require minimal guidance for complex situations
Education and Experience:
Minimum of a bachelor’s degree preferably in Life Science, Physical Science, Nursing, or Biological Science requiredAdvanced degree desirable.BS/BA with at least 4 years, MS with at least 3 years, PhD with at least 2 years of relevant experience preferredPrevious experience in clinical research or equivalent is requiredExperience working well with cross-functional teams is requiredExperience managing projects is requiredMedical device experience highly preferredExtensive experience with EU Commission Regulation 2017/745 Medical Device Regulation (MDR) and/or MEDDEV 2.7 highly preferredRelevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,...)Clinical/medical background a plusExperience in therapeutic space (breast augmentation and reconstruction) a plus
Specific Role Requirements and Skills:
Good understanding of clinical research science and processes along with an understanding of product development processes, team dynamics, clinical trends, and global clinical trial regulations;Ability to provide scientifically strategic and scientific clinical research input across Life-Cycle Management (LCM) projects;Ability to provide same for New Products a plusProven track record in delivering clinical projects within clinical/ surgical research setting, on time, and in compliance to SOPs and regulations;Strong presentation and technical writing skills;Strong written and oral communication skills;Strong computer skills and competence with use of Microsoft Excel, Word, PowerPoint, and EndNote or other reference management softwareDemonstrate competencies in the following area are required:Behave and lead in a professional and ethical mannerAdvanced technical writing skillsAdvanced project management skills with ability to handle multiple projects
The Application Process:
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
Key words:
PMCF , Medical Writer, CRO, Consultant, LCM, New Product, Clinical Writing
#J-18808-Ljbffr