Head of Medical Writing
Posted on: November 19, 2022
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 ".
- 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
- Serve as a subject matter expert on clinical aspects of
- 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.
- 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
- Experience working in a cross-functional, collaborative
- Excellent written and verbal communication skills
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