Principal Medical Writer (Device)

PPG US ProPharma Group, LLC; Chicago (IL); Hybrid; USD 120,000 - 160,000; Full time

Job summary

ProPharma Group in the United States seeks an experienced Medical Writer to lead cross-functional projects, author regulatory and clinical documents, and mentor junior writers. The role emphasizes strong communication with clients and internal teams to ensure on-time, compliant deliverables.

The candidate should have 7+ years of experience in writing clinical/regulatory documents for drugs, biologics, or devices, and a solid grasp of FDA and ICH guidelines, with hybrid work options and a

Qualifications

• Advanced knowledge of clinical research principles and data presentation.
• Strong understanding of FDA and applicable regulatory requirements.
• Experience with regulatory submission processes and documents.
• Expert word processing skills in MS Word with tables, graphs and figures.

Responsibilities

• Ensure communication on project- and program-related matters with medical writing leadership and internal resources.
• Manage clinical program documents (protocols, IBs, ICFs, study reports, etc.).
• Lead cross-functional coordination to manage medical writing and QC deliverables.
• Independently author high-quality medical writing deliverables across phases and therapeutic areas.
• Supervise, train, and mentor less experienced medical writers.
• Adhere to regulatory standards (ICH, FDA, EU guidelines) and templates.
• Manage client expectations, lead meetings, and maintain deliverable timelines.
• Collaborate with SMEs to produce deliverables and coordinate QC reviews.
• Review statistical outputs for content accuracy and consistency.
• Perform peer review of documents written by others when required.
• Support administrative tasks such as timelines and trackers.

Skills

Clinical research

Regulatory knowledge

Regulatory submissions

MS Word

Project management

Communication

AMA style

Relationship building

Time management

Team collaboration

Growth mindset

Education

Bachelor's degree or higher in medical/scientific discipline

Tools

MS Word

Job description

For the past 25 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 & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Essential Functions

• Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants as applicable.
• 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.
• Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverables as assigned.
• 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).
• Supervises, trains, and mentors less experienced medical writers, as necessary.
• 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.
• Strives to complete medical writing deliverables on time and within budget.
• 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.
• Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables.
• Coordinates QC reviews of documents and maintains audit trails of changes as applicable.
• Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.
• If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).
• Performs peer review of documents written by other medical writers, as required.
• Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).
• Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
• Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
• Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
• Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.
• Participates in and leads departmental initiatives (e.g., process improvement, lunch and learns, etc.).
• Other duties as assigned.

Necessary Skills and Abilities

• Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.
• Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
• Advanced understanding of regulatory submission requirements and processes.
• Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.
• Exceptional project management skills and strong communication skills with a high attention to detail and quality.
• English language proficiency and familiarity with American Medical Association (AMA) style.
• Strong experience in relationship building and strategic collaboration on key business accounts.
• Thinks proactively, takes initiative, and willingly takes on new challenges.
• 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.
• Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.
• Works effectively in a collaborative team environment.
• Demonstrates a growth mindset and positive outlook in all work activities.

Educational Requirements

Bachelor’s degree or higher, preferably in medical or scientific discipline.

Experience Requirements

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. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a casebycase basis.

Diversity and Inclusion

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.

Recruitment Process

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.

Remote Working

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.