Qureos Mentor

ProPharma Group

<div><div>For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.</div><div></div><div><div><div>
Essential Functions:</div></div></div><div><div><ul><li><div>
With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents).</div></li></ul></div><div><ul><li><div>
Supervises and mentors less experienced medical writers, as necessary.</div></li></ul></div><div><ul><li><div>
Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.</div></li></ul></div><div><ul><li><div>
Strives to complete medical writing deliverables on time and within budget.</div></li></ul></div><div><ul><li><div>
With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.</div></li></ul></div><div><ul><li><div>
Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.</div></li></ul></div><div><ul><li><div>
Coordinates QC reviews of documents and maintains audit trails of changes as applicable.</div></li></ul></div><div><ul><li><div>
Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.</div></li></ul></div><div><ul><li><div>
If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).</div></li></ul></div><div><ul><li><div>
Performs peer review of documents written by other medical writers, as required.</div></li></ul></div><div><ul><li><div>
Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).</div></li></ul></div><div><ul><li><div>
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.</div></li></ul></div><div><ul><li><div>
Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.</div></li></ul></div><div><ul><li><div>
Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.</div></li></ul></div><div><ul><li><div>
Brings issues and potential concerns to line manager/client oversight manager&rsquo;s attention and proposes possible solutions for consideration by management team.</div></li></ul></div><div><ul><li><div>
Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).</div></li></ul></div><div><ul><li><div>
Other duties as assigned.</div></li></ul></div></div><div></div><div><div><div>
Necessary Skills and Abilities:</div></div></div><div><div><ul><li><div>
Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.</div></li></ul></div><div><ul><li><div>
Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.</div></li></ul></div><div><ul><li><div>
Advanced understanding of regulatory submission requirements and processes.</div></li></ul></div><div><ul><li><div>
Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.</div></li></ul></div><div><ul><li><div>
Exceptional project management skills and strong communication skills with a high attention to detail and quality.</div></li></ul></div><div><ul><li><div>
English language proficiency and familiarity with American Medical Association (AMA) style.</div></li></ul></div><div><ul><li><div>
Strong experience in relationship building and strategic collaboration on key business accounts.</div></li></ul></div><div><ul><li><div>
Thinks proactively, takes initiative, and willingly takes on new challenges.</div></li></ul></div><div><ul><li><div>
Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.</div></li></ul></div><div><ul><li><div>
Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.</div></li></ul></div><div><ul><li><div>
Works effectively in a collaborative team environment.</div></li></ul></div><div><ul><li><div>
Demonstrates a growth mindset and positive outlook in all work activities.</div></li></ul></div></div><div></div><div><div><div>
Educational Requirements:</div></div></div><div><div><ul><li><div>
Bachelor&rsquo;s degree or higher, preferably in medical or scientific discipline.</div></li></ul></div></div><div></div><div><div><div>
Experience Requirements:</div></div></div><div><div><ul><li><div>
Minimum of 5 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.</div></li></ul></div><div><ul><li><div>
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis.</div></li></ul></div></div><div>
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.</div><div></div><div>
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.</div><div></div><div>
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.</div><div></div><div>
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***</div></div>

Senior Medical Writer

<div><div>For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.</div><div></div><div>
Uses R and companion software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements.</div><div>
Summary of the Essential Functions of the Job</div><ul><li> Data preparation and cleaning:</li></ul><div>
o Cleaning and transforming raw clinical trial data from various sources to ensure accuracy and consistency for PK/PD analysis.</div><ul><li> Programming PK/PD analyses:</li></ul><div>
o Writing R or Rmarkdown code to perform descriptive analysis of PK/PD data and statistical analysis of exposure-response relationships.</div><ul><li> Data visualization:</li></ul><div>
o Creating clear and informative graphs and tables to effectively communicate PK/PD findings.</div><ul><li> CDISC compliance:</li></ul><div>
o Ensuring data is formatted according to CDISC standards for regulatory submissions</div><ul><li> Validation and quality control:</li></ul><div>
o Performing thorough validation checks on programming code and analysis results to maintain data integrity.</div><ul><li> Identifies problems and develops tools that increase the efficiency and capacity of the Clinical PK/PD Programming group.</li><li> Provide trainings to fellow programmers on industrial guidances, new or enhanced features of software tools that are relevant or applicable to job function above.</li></ul><div>
Minimum Requirements</div><ul><li> Bachelor&rsquo;s degree in Math, Stats, Computer Science or similar</li><li> 7+ years of industrial experience</li><li> Must have advanced R programming skills, including tidyverse, ggplot2, Markdown, Quarto, Shiny, etc. Python and/or SAS programming skills are a plus, but not required.</li><li> Knowledge of CDISC standards (SEND, SDTM, and ADaM) is required.</li><li> Desire to work in clinical PK/PD &ndash; knowledge and experience of PK/PD concepts and related programming is highly desirable.</li><li> Experience visualizing/presenting data for internal stakeholders or clients</li><li> Capable of implementing more advanced modeling and statistical procedures as requested by study team.</li><li> Strong understanding of clinical trial data and extremely hands on in data manipulations, analysis, and reporting/modeling of analysis results. Including handling of data issues and uncleaned data.</li><li> Professional attitude, self-motivated, logical thinking</li><li> Excellent attention to detail</li><li> Strong organization skills and ability to work on multiple tasks simultaneously while achieving quality standards and meeting deadlines</li><li> Good verbal and written communication skills. Strong interpersonal skills and ability to work collaboratively across teams</li><li> Ability to problem solve and develop innovative approaches along with a drive to learn and master new techniques and technologies</li></ul><div>
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.</div><div></div><div>
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.</div><div></div><div>
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.</div><div></div><div>
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***</div></div>

R Programmer (PK/PD Experience)

<div><div>For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality &amp; compliance, pharmacovigilance, medical information, and R&amp;D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners&rsquo; most high-profile drug and device programs.</div><div></div><div><div><div>
Essential Functions:</div></div></div><div><div><ul><li><div>
Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.</div></li></ul></div><div><ul><li><div>
Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents) as assigned.</div></li></ul></div><div><ul><li><div>
Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned.</div></li></ul></div><div><ul><li><div>
Independently authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).</div></li></ul></div><div><ul><li><div>
Supervises, trains, and mentors less experienced medical writers, as necessary.</div></li></ul></div><div><ul><li><div>
Adheres to established regulatory standards/guidelines including but not limited to: ICH E3 or E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.</div></li></ul></div><div><ul><li><div>
Strives to complete medical writing deliverables on time and within budget.</div></li></ul></div><div><ul><li><div>
Independently manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.</div></li></ul></div><div><ul><li><div>
Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables.</div></li></ul></div><div><ul><li><div>
Coordinates QC reviews of documents and maintains audit trails of changes as applicable.</div></li></ul></div><div><ul><li><div>
Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.</div></li></ul></div><div><ul><li><div>
If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).</div></li></ul></div><div><ul><li><div>
Performs peer review of documents written by other medical writers, as required.</div></li></ul></div><div><ul><li><div>
Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).</div></li></ul></div><div><ul><li><div>
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.</div></li></ul></div><div><ul><li><div>
Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.</div></li></ul></div><div><ul><li><div>
Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.</div></li></ul></div><div><ul><li><div>
Brings issues and potential concerns to line manager/client oversight manager&rsquo;s attention and proposes possible solutions for consideration by management team.</div></li></ul></div><div><ul><li><div>
Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).</div></li></ul></div><div><ul><li><div>
Other duties as assigned.</div></li></ul></div></div><div></div><div><div><div>
Necessary Skills and Abilities:</div></div></div><div><div><ul><li><div>
Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.</div></li></ul></div><div><ul><li><div>
Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.</div></li></ul></div><div><ul><li><div>
Advanced understanding of regulatory submission requirements and processes.</div></li></ul></div><div><ul><li><div>
Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.</div></li></ul></div><div><ul><li><div>
Exceptional project management skills and strong communication skills with a high attention to detail and quality.</div></li></ul></div><div><ul><li><div>
English language proficiency and familiarity with American Medical Association (AMA) style.</div></li></ul></div><div><ul><li><div>
Strong experience in relationship building and strategic collaboration on key business accounts.</div></li></ul></div><div><ul><li><div>
Thinks proactively, takes initiative, and willingly takes on new challenges.</div></li></ul></div><div><ul><li><div>
Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.</div></li></ul></div><div><ul><li><div>
Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.</div></li></ul></div><div><ul><li><div>
Works effectively in a collaborative team environment.</div></li></ul></div><div><ul><li><div>
Demonstrates a growth mindset and positive outlook in all work activities.</div></li></ul></div></div><div></div><div><div><div>
Educational Requirements:</div></div></div><div><div><ul><li><div>
Bachelor&rsquo;s degree or higher, preferably in medical or scientific discipline.</div></li></ul></div></div><div></div><div><div><div>
Experience Requirements:</div></div></div><div><div><ul><li><div>
Minimum of 7 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.</div></li></ul></div><div><ul><li><div>
Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis.</div></li></ul></div></div><div>
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.</div><div></div><div>
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.</div><div></div><div>
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.</div><div></div><div>
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***</div></div>

Principal Medical Writer

Join ProPharma Group and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

ProPharma Group

About Company

Senior Medical Writer

R Programmer (PK/PD Experience)

Principal Medical Writer