Senior Medical Writer Job at Lifelancer in Rockville

Job Title: Senior Medical Writer

Job Location: Rockville, MD, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Overview

The Senior Medical Writer will be responsible for authoring and revising clinical and regulatory documents for submission to the FDA and other agencies, and to support other clinical communication efforts, including the development of abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.

Responsibilities

• Prepares Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development.
• Leads the development and authoring of clinical protocols, clinical study reports, investigator brochures, and clinical summaries in support of regulatory filings in collaboration with clinical study teams.
• Leads the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors.
• Lead the development of client-directed programs and projects to ensure that high-quality outputs are delivered within agreed timelines and within budget.
• Organizes, conducts, and leads cross-functional document development meetings.
• Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem-solving ability.
• Represents medical writing on study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments.
• Lead or participate in development of medical writing processes and infrastructure development.
• Performs other duties as assigned.
• Complies with all policies and standards.

Qualifications

• BS/BA degree in a scientific or health-related field required; Masters, PharmD, or PhD preferred.
• At least 5 years of experience, or equivalent, in clinical and regulatory submissions writing in the pharmaceutical, biotech, device, medical communications, or CRO industries.
• Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
• Understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, research methodology, the regulatory environment including FDA/ICH guidelines, and principles of GXP/ICH/CTD, and other global standards.
• Strong emphasis on medical terminology and/or research methodology.
• Ability to work collaboratively and coordinate the efforts of team members to resolve comments, and produce a final high-quality document.
• Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines.
• Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines without compromising document quality.
• Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off
• Tuition Reimbursement
• 401k Retirement Plan
• Work From Home Anywhere in the US
• Maternal/Paternal Leave
• Casual Dress Code & Work Environment

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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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