Medical Writer/Sr Medical Writer

Website InnoCare Pharma Inc. (US)

 

InnoCare Pharma is a clinical-stage biopharmaceutical company dedicated to discovering, developing, and commercializing best-in-class and/or first-in-class drugs for the treatment of cancer and autoimmune diseases.

InnoCare has strong in-house innovation capabilities, holding multiple foreign and domestic patents with a rich product pipeline target liquid tumors, solid tumors, and autoimmune diseases. Our team has discovered and developed our current pipeline of over 10 novel drug candidates, including our core product candidate Orelabrutinib, whose NDA was accepted and granted priority review by the NMPA earlier this year.

InnoCare was co-founded by Professor Shi Yigong, a world-renowned structural biologist, and Dr. Cui Jisong, an outstanding leader in the biopharmaceutical industry. We have nearly 300 employees, including over 100 researchers. Our core R&D staff brings rich experience from the world’s top pharmaceutical companies, such as Pfizer, Bristol-Myers Squibb, Merck, Johnson & Johnson, Bayer, etc. We are a truly global biopharmaceutical company with sites in Beijing, Nanjing, Shanghai, and Guangzhou, in addition to branches in New Jersey and Boston for US development and clinical management.

On March 23, 2020, InnoCare was officially listed on the Hong Kong Stock Exchange (code: 9969). Our vision is to become a world-class leader in innovative medicine and lead China’s medicinal research into a new era.

 

Medical Writer/Sr Medical Writer

Job Title: Medical Writer/Sr Medical Writer

Reports to: Senior Director, Regulatory

Location: Princeton, NJ (preferred)/Remote

 

Job Summary

We are looking for an experienced medical writer to lead the preparation of clinical documents for Regulatory submission, including IBs, ICFs, Clinical Study Protocols, Clinical Study Reports, Clinical Summaries/Overviews and other clinical related documents. BS degree required, advanced degree preferred. The candidate should have 3 years of relevant pharmaceutical industry or academic institute experiences in medical writing for regulatory submission. Domain knowledge in clinical development, regulatory process and guidelines essential. Expertise in English language skills and expert in Word processing, editing, standardizing and formatting. Certification in medical writing a plus. Career advancement potential. NJ-based preferred while other locations possible.

 

Job Responsibilities

  • Lead medical writing on clinical documents and publications. Act as a significant scientific contributor and subject matter expert in preparation of clinical documentation. Work closely with Regulatory and Clinical teams on clinical document writing.
  • Lead preparation or revision of clinical document, including Protocols, Clinical Study Reports, IBs, ICFs, Clinical Summaries/Overviews, and other clinical related documents to support regulatory submission. Conduct review meetings with the team. Ensure timely completion of required documentation.
  • Support preparation and review of clinically relevant contents in DSUR, regulatory packages, publications and other documents.
  • Coordinate and collaborate with clinical, medical research, pharmacovigilance and nonclinical research functions in discussions and interpretations of relevant data and information for clinical documents. Review and QC documents according to applicable standards.
  • Collect, analyze and summarize competitive intelligence information to support pipeline development plan, clinical development strategy and trial design.
  • Maintain and update company SOPs related to clinical documentation. Maintain document version controls and archive relevant clinical documents in compliance with Regulatory and company internal requirements.
  • Work with Quality Assurance throughout regulatory audit process to prepare responses and answer questions as appropriate.
  • Help with review and QC of other documents in regulatory submissions as needed.
  • Be able to deliver on time with quality in a multi-tasking working environment.

 

Job Qualifications

  • Bachelor degree required, advanced degree in a relevant scientific/clinical field preferred.
  • 3 years of relevant pharmaceutical industry or academic institute experiences in medical writing, clinical development, data interpretation and regulatory submission support required
  • Certification in medical writing a plus
  • Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, ICF, clinical sections of other regulatory documents) according to US and international regulations, guidance and company guidelines.
  • Strong communication and problem solving skills. Experiences working with cross-functional teams and external vendors.
  • Expertise in English language skills and expert in word processing, editing, standardizing and formatting.
  • Preferred location in New Jersey, but remote-based is an option
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