Sr. Medical Writer

Overview:

Senior Medical Writer

India Bangalore (hybrid)

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:

• 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

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
- Well-organized with demonstrated ability to prioritize tasks, work simultaneously on

multiple projects, and complete high-quality documents according to timelines without
- Ability to work in a fast-paced, cohesive, collaborative team-oriented work environmentcompromising document quality
- Independently motivated with good problem-solving skills allowing analysis, synthesis and

compilation of data from a broad range of disciplines

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