Manager/Senior Manager, Medical Writing

Sironax·
Beijing or Shanghai, China
2w ago
Full-timeSeniorMedical WritingUnknownUnknownPhD
Market Rate — Computer User Support Specialists
25th
$45K
Median
$58K
75th
$74K

BLS 2024 data (national)

Description

Beijing or Shanghai, China. We are seeking an experienced and highly motivated Manager/Senior Manager, Medical Writing to join our team. This role is responsible for the strategic planning, preparation, and delivery of high-quality clinical, preclinical, and regulatory documents in support of the company’s drug development programs. The ideal candidate should possess broad experience in authoring and managing a wide range of clinical and preclinical documents, capable of handling various document types from early-stage research to clinical submissions. The ability to draft preclinical reports will be considered a strong preference. Key Responsibilities include leading or being responsible for the planning, preparation, and delivery of clinical, preclinical, and regulatory documents, authoring or overseeing key documents, ensuring documents are scientifically accurate and aligned with regulatory strategies, collaborating cross-functionally, mentoring junior medical writers, and supporting the development and maintenance of related SOPs, templates, and style guides.

Requirements

Advanced degree in life sciences (Ph.D., Pharm.D., or M.S. preferred). Minimum of 6 years of medical writing experience within the pharmaceutical, biotechnology, or CRO industry. Proven experience in authoring clinical study protocols, clinical study reports, Investigator’s Brochures (IBs), DSURs, IND submissions, and FDA meeting packages. Experience in drafting preclinical study reports or related non-clinical documents is preferred. Familiarity with global regulatory requirements (e.g., FDA, ICH, EMA, NMPA). Strong project management skills with the ability to prioritize and manage multiple tasks in a fast-paced environment. Excellent written and verbal communication skills in both Chinese and English. Proficiency in MS Word and document management systems; experience with electronic submission tools is a plus.
Sironax

Sironax

BIOTECHNOLOGY

Therapies that address the root cause of age-related degenerative disease

LocationChina - Beijing
Employees51-200
Open Jobs12
Unknownneurodegenerative and age-related diseasesNeurodegenerative disease or inflammation-relatedBiotech/PharmaDrug Discovery
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