Medical Writing

Objectives and scope of the job

This role will be worked under the guidance of Medical Writing Associate Director to ensure the on-time delivery of high-quality clinical regulatory documents, including but not limited to, study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs.

Responsibilities

1. Collaborate with key project team stakeholders and in-house and contract medical writers, plan and prepare clinical and regulatory documents necessary for all phases of drug development following agreed timelines. responses;

2. Apply in-depth knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects;

3. Perform high-quality peer-review/QC for documents written within the MW&MI group or elsewhere (e.g., vendors/CROs/project teams);

4. Conduct literature searches to keep updated with medical and other scientific developments relevant to the product and competitor products;

5. Provide writing/research support for publishing activities in medical/scientific journals as necessary;

6. Represent the MW&MI function in cross-functional team interactions;

7. If needed, provide vendor management activities for outsourced projects; 8. Perform other duties as assigned by the supervisor.

Requirements

1. Education Master’s degree in Pharmacy, Medicine, or Life Science

2. Further Education Physician or PhD

3. Experience Over 2 years of working experience in scientific and/or regulatory medical writing

4. Language Skills Good command of English

5. Special Knowledge / Skills Excellent scientific and analytical thinking;

6. Microsoft Office Suite proficient (Excel, Outlook, PowerPoint, Word, etc.);

7. Excellent communication skills (written and verbal)

8. Solid problem solving and time management skills

9. Great interpersonal skills

10. Strong attention to detail

11. Highly organized