Principal Medical Writer (Clinical & Regulatory Documentation) – Remote | ProPharma Careers
About ProPharma
ProPharma is a leading global consulting organization with over 20 years of experience supporting pharmaceutical, biotechnology, and medical device companies. Through its advise-build-operate model, ProPharma delivers comprehensive solutions across regulatory sciences, clinical research, pharmacovigilance, medical information, and quality & compliance. The company partners with clients to accelerate development timelines and successfully deliver innovative therapies to patients worldwide.
Job Overview
ProPharma is hiring a Principal Medical Writer to lead the development, management, and delivery of complex clinical and regulatory documents across the product lifecycle. This senior-level role requires deep expertise in medical writing, regulatory submissions, and cross-functional leadership, along with the ability to independently manage client engagements, timelines, and high-impact deliverables.
Job Location & Work Model
Work Type: Remote
Employment Type: Full-time
Key Responsibilities
Medical Writing & Document Leadership
Lead the authoring and management of clinical and regulatory documents, 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 aggregate safety reports
IND, NDA, BLA, MAA, and eCTD submission-level documents
Ensure all deliverables meet high standards of quality, accuracy, and regulatory compliance
Program & Stakeholder Management
Manage clinical program documentation and oversee end-to-end delivery for assigned clients
Act as a key point of contact for clients, internal teams, and medical writing leadership
Lead project kickoff meetings, review cycles, and timeline management
Coordinate cross-functional teams, including clinical operations, biostatistics, data management, and regulatory affairs
Quality & Compliance Oversight
Ensure adherence to global regulatory guidelines (ICH E3, ICH E6(R2), FDA, EMA, EU MDR/IVDR) and company SOPs
Oversee quality control (QC) processes, audit trails, and document consistency
Review statistical analysis plans and data presentation formats (tables, figures, listings)
Perform QC and peer reviews of documents as required
Leadership & Mentorship
Supervise, train, and mentor junior medical writers
Lead departmental initiatives such as process improvement and knowledge-sharing programs
Identify risks, inefficiencies, and improvement opportunities, proposing actionable solutions
Project & Budget Management
Manage multiple projects simultaneously while ensuring timely delivery within budget
Track deliverables, maintain project timelines, and communicate scope changes to leadership
Support administrative tasks including tracker updates and meeting coordination
Required Skills and Competencies
Advanced expertise in clinical and regulatory medical writing
Strong knowledge of global regulatory frameworks (FDA, EMA, ICH guidelines)
Proven ability to manage complex regulatory submissions (IND, NDA, BLA, MAA)
Exceptional project management and organizational skills
Advanced proficiency in MS Word, including formatting of tables, graphs, and figures
Strong communication and client management skills
Familiarity with AMA (American Medical Association) writing style
Ability to lead cross-functional teams and manage stakeholder expectations
Strong analytical thinking and problem-solving capabilities
High attention to detail with a quality-driven mindset
Educational Qualifications
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related scientific discipline
Advanced degree preferred
Experience Requirements
Minimum: 7+ years of experience in medical writing (clinical and/or regulatory)
Freshers: Not eligible
Required: Experience in CRO, pharmaceutical, or biotechnology industry
Preferred: Extensive experience with global regulatory submissions and leadership of writing teams
Why Join ProPharma
Lead high-impact global regulatory and clinical documentation projects
Work with top-tier pharmaceutical and biotech clients
Opportunity to mentor teams and influence medical writing strategy
Collaborative and innovation-driven work environment
Remote flexibility with global 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 will 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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