Medical Writer

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. As the world’s largest RCO (Research Consulting Organization), 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.

The Medical Writer I position is responsible for authoring medical writing deliverables with a focus on quality, accuracy, and efficiency, and provides medical writing support to ProPharma clients.

Essential Functions:

• Authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) including but not limited to protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries. May participate in authoring more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) with supervision by senior personnel.
• 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.
• Strives to complete medical writing deliverables on time and within budget.
• Interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines, with support from senior personnel (as needed).
• Interacts and collaborates as needed 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).
• Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings), with support from senior personnel (as needed).
• 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.\
• Brings issues and potential concerns to line manager/client oversight manager’s attention.
• Other duties as assigned

Necessary Skills and Abilities:

• Basic knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
• Basic understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.
• Basic 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.
• 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.
• Ability to think proactively and take initiative, with a willingness to take on new challenges.
• Ability to work independently and contact management team proactively when additional support and resources are needed.
• Ability to work 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:

• 0-2 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.
• Some experience writing/editing scientific documents or experience in reviewing scientific data preferred.
• Other professional and/or educational ex