Senior Medical Writer II
Location: India
Job Category: Medical Writing / Clinical Research
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About ProPharma:
ProPharma has spent the past 20 years improving patient health and wellness by empowering biotech, pharmaceutical, and medical device organizations with expert guidance. Through an advise-build-operate model, ProPharma partners with clients across the entire product lifecycle, offering regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology services. ProPharma delivers customizable solutions to de-risk and accelerate its partners' drug and device programs.
Position Overview:
ProPharma is seeking a Senior Medical Writer II who will author, edit, and manage the development of a variety of high-quality clinical, safety, regulatory, and disclosure documents across all phases of clinical research. This role also includes leadership responsibilities, such as supervising and mentoring less experienced writers.
Essential Functions:
Independently author and edit clinical, regulatory, safety, and device documents including protocols, study reports, IBs, ICFs, DSURs, plain language summaries, and complex documents (e.g., PBRERs, NDAs, BLAs, MAAs, eCTD submissions).
Supervise, train, and mentor junior medical writers as needed.
Ensure compliance with ICH E3/E6(R2), EU MDR/IVDR, internal SOPs, client standards, and approved templates.
Manage client communications, expectations, and project deliverable timelines with minimal supervision.
Lead internal and client meetings, including project kickoffs and comment review sessions.
Collaborate with subject matter experts across clinical operations, data management, biostatistics, and regulatory affairs to produce deliverables.
Coordinate quality control (QC) reviews of documents and maintain detailed audit trails.
Review statistical analysis plans and related outputs for content, grammar, formatting, and consistency.
Perform peer and QC reviews of documents authored by other writers when necessary.
Assist in administrative project tasks, such as maintaining timelines and updating trackers.
Stay current with industry practices and regulatory requirements.
Work within assigned budgets and notify management of any out-of-scope work.
Manage multiple projects simultaneously and proactively seek assistance when needed.
Participate in departmental initiatives and process improvements.
Other duties as assigned.
Necessary Skills and Abilities:
Advanced knowledge of clinical research principles and the ability to present complex clinical data.
Strong understanding of FDA regulations, global regulatory standards, and submission requirements.
Proficiency in MS Word, including skills in creating tables, graphs, and figures.
Excellent project management, communication, and attention to detail skills.
Fluency in English and familiarity with American Medical Association (AMA) writing style.
Strong relationship-building and strategic collaboration abilities.
Proactive, solutions-oriented thinker with strong time-management skills.
Ability to work independently and effectively within a collaborative environment.
Demonstrates a growth mindset and positive attitude toward work.
Educational Requirements:
Bachelor's degree or higher, preferably in a medical or scientific discipline.
Experience Requirements:
Minimum of 6 years of experience writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics within a CRO, pharmaceutical, or biotechnology environment.
Other educational or professional experience may also be considered on a case-by-case basis.
Workplace Commitment:
ProPharma fosters a diverse, equitable, and inclusive environment where employees are encouraged to bring their authentic selves to work. As an Equal Opportunity Employer, ProPharma creates a supportive workplace where innovation and collaboration thrive.
Additional Information:
Unsolicited resumes from third-party recruiters will not be accepted.
No phone calls or emails regarding this posting, please.
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