Job Title: Senior Medical Writer
Department: Biometrics/Biostatistics
Employment Type: Regular Full-Time
Job ID: 2502
Location: US – Remote
Company Overview:
Emmes Group has been a trusted leader in clinical research for over 47 years, providing services to the US government and expanding into public-private partnerships and commercial biopharma. With expertise spanning cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience, Emmes is committed to delivering research that positively impacts patients’ lives. The company fosters a collaborative culture that balances high performance with people-centered values.
Position Summary:
The Senior Medical Writer will create, revise, and manage clinical and regulatory documents required for FDA submissions and other regulatory agencies. The role involves supporting clinical communications through abstracts, presentations, and manuscripts for peer-reviewed publications. This position requires close collaboration with clinical teams, statisticians, and regulatory personnel to ensure high-quality deliverables.
Key Responsibilities:
Author and revise regulatory documents such as IND applications, NDAs, MAAs, amendments, and annual reports.
Lead development and authoring of clinical protocols, study reports, investigator brochures, and clinical summaries for regulatory filings.
Develop abstracts, presentations, and manuscripts for medical congresses and scientific journals.
Manage client-directed projects ensuring timely delivery of quality outputs within budget.
Organize and lead cross-functional meetings to coordinate document development.
Collaborate closely with statistics and programming teams for statistical analysis plans and outputs.
Represent medical writing on study teams and contribute to overall program strategy.
Participate in or lead initiatives to improve medical writing processes and infrastructure.
Perform other duties as assigned and comply with company policies and standards.
Qualifications:
Education & Experience:
BS/BA in a scientific or health-related field required; Master’s, PharmD, or PhD preferred.
Minimum 5 years of experience in clinical and regulatory writing within pharma, biotech, medical communications, or CROs.
Skills & Knowledge:
Strong ability to communicate scientific and clinical data clearly and effectively in English.
Knowledge of clinical product development, research methodologies, biostatistics, medical terminology, and regulatory guidelines (FDA/ICH/GXP/CTD).
Proven ability to work collaboratively with diverse teams and manage multiple projects simultaneously.
Self-motivated with strong problem-solving and organizational skills.
Ability to thrive in a fast-paced, team-oriented environment.
Why Work at Emmes?
Directly impact public health initiatives worldwide and locally.
Flexible Approved Time Off policy.
Work from home anywhere in the U.S.
Competitive benefits including tuition reimbursement, 401(k), and parental leave.
Opportunities for community engagement through Emmes Cares.
Casual and supportive work environment.
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