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Head of Medical Writing

Company: ------------
Location: Cambridge
Posted on: November 19, 2022

Job Description:

Simcere Pharmaceutical Group Limited(2096.HK) is rapidly transitioning to an innovation and R&D-driven pharmaceutical company, with a mission of "providing today's patients with medicines of the future." Simcere focuses on three therapeutic areas: oncology, central nervous system diseases and autoimmune diseases, with a diversified product portfolio and industry-leading capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with world leading pharmaceutical companies and biotechnology companies, in an effort to bring more global life science breakthroughs to patience in China. We have been continuously recognized as one of the "Top 10 Innovative Pharmaceutical Enterprises in China" and "Top 100 Pharmaceutical Manufacturing Enterprises of China ".
Responsibilities:

  • Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Prepare/coordinate and deliver high-quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required.
  • Act as a Medical Writing coordinator for the preparation of Drug Safety-related documents such as PSUR/PBRERs.
  • Write and or edit clinical study documentation, including clinical investigational plans/protocols, Investigator's Brochures, Periodic reports, Clinical Investigational Reports/Clinical Study Reports.
  • Serve as a subject matter expert on clinical aspects of technical documentation.
  • Build and ensure maintenance of knowledge base to improve the overall medical content of documents and ensure adherence to multinational regulatory standards.
  • Collaborate effectively across Clinical, Regulatory, Quality, Biostatistics, Data Management and CMC in a team environment. Qualifications:
    • Minimum BS in Biological Sciences or related field with 5-10 years of Medical Writing experience
    • Experience as lead writer for key documents included in major US and/or international regulatory submissions required
    • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production
    • Ability to manage competing priorities in a fast-paced environment
    • Experience working in a cross-functional, collaborative environment
    • Excellent written and verbal communication skills

Keywords: ------------, Cambridge , Head of Medical Writing, Advertising , Cambridge, Massachusetts

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