Senior Medical Writer

Emmes; Rockville (MD); Remote; USD 70,000 - 110,000; Full time

Job summary

An established industry player is seeking a Senior Medical Writer who will play a crucial role in authoring clinical and regulatory documents. This position offers the opportunity to contribute to groundbreaking medical research and ensure compliance with FDA guidelines. The ideal candidate will possess strong writing skills and a collaborative spirit, working closely with cross-functional teams to deliver high-quality outputs. Join a forward-thinking company that values innovation and has a direct impact on public health initiatives, while enjoying the flexibility of remote work and a supportive work environment.

Benefits

Flexible Approved Time Off

Tuition Reimbursement

401k Retirement Plan

Work From Home Anywhere in the US

Maternal/Paternal Leave

Casual Dress Code & Work Environment

Qualifications

• 5+ years of experience in clinical and regulatory submissions writing.
• Strong understanding of clinical research and regulatory environments.

Responsibilities

• Author clinical and regulatory documents for FDA submissions.
• Lead development of clinical protocols and study reports.

Skills

Clinical Writing

Regulatory Submissions

Scientific Communication

Problem Solving

Collaboration

Education

BS/BA in Scientific or Health-related Field

Masters/PharmD/PhD

Job description

Overview

Senior Medical Writer

US Remote

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry-leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people-driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!

Primary Purpose

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

1. 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.
2. 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.
3. 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.
4. Lead the development of client-directed programs and projects to ensure that high-quality outputs are delivered within agreed timelines and within budget.
5. Organizes, conducts, and leads cross-functional document development meetings.
6. Closely interacts with statistics and programming departments in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem-solving ability.
7. 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.
8. Lead or participate in development of medical writing processes and infrastructure development.
9. Performs other duties as assigned.
10. Complies with all policies and standards.

Qualifications

1. BS/BA degree in a scientific or health-related field required; Masters, PharmD, or PhD preferred.
2. At least 5 years of experience, or equivalent, in clinical and regulatory submissions writing in the pharmaceutical, biotech, device, medical communications, or CRO industries.
3. Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English.
4. 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.
5. Ability to work collaboratively and coordinate the efforts of team members to resolve comments, and produce a final high-quality document.
6. Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines.
7. 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.
8. 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

CONNECT WITH US!

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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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