Senior Medical Writer (Clinical & Regulatory) – Remote | ProPharma Careers
About ProPharma
ProPharma is a globally recognized consulting organization with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, ProPharma provides end-to-end solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, and quality & compliance. The organization partners with clients to accelerate product development and deliver innovative therapies to patients worldwide.
Job Overview
ProPharma is seeking an experienced Senior Medical Writer to develop high-quality clinical, regulatory, and safety documents across all phases of drug and device development. This role requires advanced expertise in medical writing, regulatory submissions, and cross-functional collaboration, along with the ability to manage multiple deliverables and client interactions independently.
Job Location & Work Model
Work Type: Remote
Employment Type: Full-time
Key Responsibilities
Author and edit high-quality medical writing deliverables, including:
Clinical study protocols and amendments
Clinical study reports (CSRs)
Investigator Brochures (IBs) and Informed Consent Forms (ICFs)
Patient narratives and plain language summaries
Clinical Evaluation Plans/Reports (CEP/CER)
DSURs, PBRERs, and other aggregate reports
IND, NDA, BLA, MAA, and eCTD submission documents
Manage complex regulatory and submission-level documentation with minimal supervision
Lead and participate in client meetings, including project kickoff and review discussions
Collaborate with cross-functional teams (clinical operations, biostatistics, regulatory affairs, data management)
Supervise and mentor junior medical writers as needed
Ensure compliance with global regulatory guidelines (ICH E3/E6(R2), FDA, EU MDR/IVDR) and company SOPs
Coordinate quality control (QC) reviews and maintain audit trails
Review statistical analysis plans and data presentation formats (tables, figures, listings)
Perform peer reviews and QC checks of documents
Manage timelines, budgets, and multiple concurrent writing projects
Identify risks or inefficiencies and propose solutions to improve deliverable quality
Support internal initiatives such as process improvement and knowledge sharing
Required Skills and Competencies
Advanced knowledge of clinical research and regulatory medical writing
Strong understanding of global regulatory frameworks (FDA, EMA, ICH guidelines)
Proven ability to interpret and present complex clinical and scientific data
Excellent project management and organizational skills
Advanced proficiency in MS Word, including formatting of tables, graphs, and figures
Strong communication and stakeholder management skills
Familiarity with AMA (American Medical Association) writing style
Ability to work independently and manage multiple priorities
High attention to detail with a quality-focused mindset
Proactive approach to problem-solving and continuous improvement
Educational Qualifications
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or related scientific discipline
Advanced degree preferred
Experience Requirements
Minimum: 5+ years of experience in medical writing (clinical and/or regulatory)
Freshers: Not eligible
Required: Experience in CRO, pharmaceutical, or biotechnology environment
Preferred: Experience with regulatory submissions (IND, NDA, BLA, MAA) and aggregate safety reports
Why Join ProPharma
Opportunity to work on global clinical and regulatory projects
Exposure to diverse therapeutic areas and advanced scientific developments
Collaborative and innovation-driven work environment
Career growth through mentorship and leadership opportunities
Remote flexibility with global client exposure
Diversity, Equity, and Inclusion
ProPharma is committed to fostering a diverse and inclusive workplace where employees are empowered to succeed. The organization values collaboration, innovation, and equal opportunity.
Application Process
All applications are reviewed by ProPharma’s recruitment team to ensure a fair and transparent hiring process. Candidates receive updates on their application status. ProPharma does not use AI-based screening tools.
Important Notice
ProPharma does not accept unsolicited resumes from third-party recruiters. Direct inquiries via phone or email regarding this role are not permitted.
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