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About the Role
ProPharma is seeking an experienced Senior or Principal Medical Writer with proven early phase experience to support a 'top 5' Pharmaceutical client. This role focuses on authoring high-quality medical writing deliverables with accuracy and efficiency, providing dedicated support to one client.
Responsibilities
- Ensures appropriate communication on project- and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultants.
- Manages clinical program documents for assigned clients, including protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, and complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).
- Leads cross-functional coordination of resources to manage medical writing and QC deliverables.
- Independently authors (writes/edits) high-quality medical writing deliverables across all phases of clinical research and in various therapeutic areas.
- Supervises, trains, and mentors less experienced medical writers.
- Adheres to established regulatory standards/guidelines including ICH E3 or E6(R2), EU MDR/IVDR, Company SOPs, client standards, and approved templates.
- Strives to complete medical writing deliverables on time and within budget.
- Independently manages client expectations and interacts directly with clients, leads team meetings, and manages deliverable timelines.
- Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc.
- Coordinates QC reviews of documents and maintains audit trails of changes.
- Reviews statistical analysis plans and table/figure/listing shells for appropriate content, grammar, format, and consistency.
- Performs QC review of documents as requested by supervisor.
- Performs peer review of documents written by other medical writers.
- Assists with project-related administrative tasks, such as creating and maintaining timelines and updating deliverable trackers.
- Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
- Understands budget specifications for assigned deliverables, works within budgeted hours, and communicates out-of-scope tasks.
- Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention.
- Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes solutions.
- Participates in and leads departmental initiatives, such as process improvement and lunch and learns.
- Performs other duties as assigned.
Requirements
- Advanced knowledge of clinical research principles and ability to interpret and present clinical data and other complex information.
- Advanced understanding of FDA and other relevant regulatory bodies, regulations, and guidelines.
- Advanced understanding of regulatory submission requirements and processes.
- Proficiency in computer technology and expert MS Word skills, including tables, graphs, and figures.
- Exceptional project management skills.
- Strong communication skills with 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.
- Proactive thinking, initiative, and willingness to take on new challenges.
- Ability to identify areas of concern or inefficiency and propose solutions.
- Exceptional time-management skills; contacts management team proactively when additional support is needed.
- Ability to work effectively in a collaborative team environment.
- Demonstrates a growth mindset and positive outlook.
Skills
- Medical Writing
- Clinical Research
- Regulatory Affairs
- MS Word
- Project Management
- Communication
- Attention to Detail
- Time Management
Location
- UK
- Ireland
Work Type
- Hybrid
- Remote
Experience Level
- Senior
- Principal
Education Level
- Bachelor's degree or higher, preferably in a medical or scientific discipline
About the Company
- 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.
- 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.
- 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.
- 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.
- ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
Equal Opportunity
- 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.