Senior Medical Writer

  • Full Time
  • US
  • 12/31/2021

Website Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer, viral hepatitis, and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.

We value our employees as our greatest assets, and we are dedicated to providing an equal employment opportunity along with creating a positive work environment where courageous innovation is encouraged and expected. Our vision is to become a world-class biotechnology company. Our highly talented team of scientists and medical professionals are all passionately sharing this common vision, and we are excited to welcome any talented members to join the big family of Ascletis. We are looking forward to having you as a prospective member of Ascletis. If you’re interested in learning more about what we have to offer, please email your CV to hr@ascletis.com.

 

Senior Medical Writer
JOB TYPE: Full-time
LOCATION: US

JOB SUMMARY:
The Senior Medical Writer at Gannex (A Member of the Ascletis Group) will support/assist in the writing, editing, formatting and overall development of clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards while meeting project timelines.

Responsibilities:

• Work effectively within the department and with cross-functional groups to assist in the development of high
quality, scientifically accurate documents under strict timelines and help to ensure consistency between
related documents
• Responsible for ensuring that assigned documents undergo Quality Control reviews and/or Quality Assurance
audits before approval, and that documents are routed correctly through the appropriate review and approval
cycles
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones,
and deliverables (eg, track the collection of clinical study report components from responsible functions
body, synopsis, safety narratives, appendices, TFLs)
• Review and edit documents, including those authored by others both internally and externally
• Develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates,
style guide, etc.)
• Ensure clinical documents adhere to A scleritis standards and regulatory guidelines

Requirements:

• At least BA/BS degree; Master’s/PhD/PharmD preferred.
• BioSciences, Pharmacology, or other health-related major preferred.
• At least 5 years of health or science-related work experience
• Certain ability to communicate, read and write in English excellent attention to detail related to grammar,
syntax, and scientific accuracy; ability to comply with company and/or industry style guides and templates; the
technical/scientific ability to critically analyze, synthesize, and present complex information in well constructed
documents
• Well organized: the ability to prioritize tasks, work simultaneously on multiple projects, and complete high quality
documents according to tight timelines and shifting priorities/demands
• Independently motivated with good problem-solving ability; a fast learner (grasps new ideas and concepts
quickly)
• Excellent interpersonal skills; a team player able to coordinate and manage communications to enable timely
reviews from other authors and reviewers and to function as a collaborative team member
• Strong project management skills
• An understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines
is a plus
• Working knowledge of drug/biologic s development, clinical research, study design, biostatistics, the
the regulatory environment and medical terminology is a plus
Computer skills requirements: Proficiency in Microsoft Word / Outlook Excel PowerPoint and Adobe Acrobat; Experience using electronic document management systems is a plus

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