San Diego, CA
Senior Medical Writer Contractor
General Job Description:
Samorn Biosciences is looking for a Senior Medical Writing Contractor who has scientific knowledge and writing expertise to effectively communicate technical, pharmaceutical, drug, and scientific medical information. Document audiences include regulatory authorities, clinical study sites, and thought leaders involved in drug, drug-device, and biologic development. The position’s focus includes clinical documents such as protocol and clinical study reports (CSRs), and regulatory submissions. This will entail some project management and leadership, working closely with internal and client team members to ensure the documents are high quality and completed in a timely fashion, compliant with SOPs, ICH/GCP/regulatory guidelines, eCTD requirements and company goals. The core responsibilities of the Senior Medical Writer, Development are listed below.
Write, edit and collaborate on development of preclinical, clinical, and sections of regulatory documents (e.g., protocols, amendments, investigator brochures, clinical study reports, DSURs, INDs, eCTD/NDA modules, clinical summaries, briefing books)
Compile, write, and edit documents covering all phases of clinical research, to include integrated summaries of data, risk/benefit analysis, etc
Assist in the analysis, synthesis and presentation of complex information for scientific presentations
Distill large amounts of clinical and scientific data into essential elements for graphical display.
Formulate key messages from clinical study data
Perform literature-based research to support writing activities
Provide QC review support as needed and ensure consistency between related documents
Understand the levels of evidence required to achieve regulatory and clinical trial goals.
Ability to coordinate, plan, and manage communications to enable timely review from other authors and reviewers and to function as a collaborative team member
Create and maintain document timelines incorporating client team input
Develop and maintain medical writing processes, SOPs, templates, and outlines for key documents
Maintain an awareness of current industry practices and regulatory requirements that affect medical writing
Keep abreast of current literature, emerging science, technological developments, and medical trends
BS, MS, PharmD, or PhD in a scientific or medical discipline with relevant experience
5+ years’ experience in the clinical/regulatory writing and editing
Basic to intermediate knowledge of biostatistical and clinical research concepts
Thorough understanding of FDA and ICH regulations and guidelines, and AMA editing standards
Experience authoring/editing CSRs and other types of clinical regulatory documents (e.g., clinical protocols, Investigator’s Brochures, NDA modules)
Proven ability to implement medical writing processes and standards
Knowledge of Microsoft Office applications, document templates, and electronic document management systems; proficiency in Word, Excel, PowerPoint, email, and the Internet
Willingness and ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment; adapts to changing deadlines and priorities
Ability to work collaboratively to coordinate the efforts of team members to complete deliverables
Exceptional oral and written communication skills
Flexible, adapts work style to meet organization needs
Application Information & Contact (How to Apply)
Please email your resume to firstname.lastname@example.org
Learn more about Samorn Biosciences here.