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Senior Medical Writer

August 29, 2018

   

 

 

 

Company Name:

Samorn Biosciences

 

Job Location:

San Diego, CA

 

Position Title: 

Senior Medical Writer

 

Position Type:

Full-time 

 

General Job Description:

 

Samorn Biosciences seeks a Senior Medical Writer with scientific knowledge and writing expertise to effectively communicate technical pharmaceutical drug and scientific medical information to regulatory authorities, clinical study sites, and thought leaders involved in drug, drug-device, and biologic development. The position’s focus includes protocol and clinical study report (CSR) development, and regulatory submissions. The position works 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 duties of the medical writer are delineated below.

 

Responsibilities:

 

  • 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.

  • 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

  • Formulate key messages from clinical study data

  • Perform literature-based research to support writing activities

  • 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

     

 

Qualifications:

 

  • BS, MS, PharmD, or PhD in a scientific or medical discipline with relevant experience

  • 5+ years’ experience in clinical/regulatory writing and editing (may consider fewer years of experience on a case-by-case basis)

  • Basic to intermediate knowledge of biostatistical and clinical research concepts

  • Thorough understanding of FDA and ICH regulations and guidelines

  • 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 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

  • Motivated, self-directed and able to work autonomously and in team settings to meet aggressive organizational goals

  • Available writing samples for Samorn Biosciences review

     

ADA Notations:

  • Ability to sit for long periods of time, handling, feeling with hands, reaching with arms

  • Regular communication (hearing/speaking)

  • Lifting up to 10 kg

  • Routine office duties including computer keyboard use

  • Vision requirements include: close vision and ability to focus

  • Noise conditions range from quiet to moderate

 

Application Information & Contact (How to Apply)

 

For more information regarding Samorn Biosciences, and to view this and other job openings, please visit the career webpage.

 

 

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