Senior Writer

Discover International; Deutschland; On-site; EUR 70,000 - 110,000; Full time

Job summary

Discover International is seeking a Senior Medical Writer to support the development of novel therapies across oncology and immunology. You will author and review clinical and regulatory documents throughout the drug development lifecycle with cross-functional teams.

The role requires an MD/PhD or equivalent, 5+ years' biotech/pharma writing experience, and strong experience with BLA submissions, CTDs, CSRs and ICH/FDA/EU CTR guidelines.

Qualifications

• MD/PhD or equivalent scientific degree required.
• Minimum 5 years of medical/scientific writing experience in biotech/pharma.
• Strong hands-on experience with BLA writing.
• Experience authoring Clinical Trial Protocols and CSRs.
• Experience with clinical regulatory documentation and Phase I-III trials.
• Knowledge of ICH guidelines, FDA requirements and EU CTR.
• Oncology and/or immunology experience desirable.
• Native-level written and spoken English.

Responsibilities

• Author and review clinical and regulatory documents with scientific accuracy and regulatory compliance.
• Draft and update Clinical Trial Protocols and CSRs (Ph I-III).
• Prepare Investigator's Brochures, CTD modules, DSURs, Annual Reports and Risk Management Plans.
• Contribute to BLA submissions and regulatory response documents.
• Review scientific and R&D reports.
• Coordinate document reviews, approvals and external medical writing activities.
• Support medical writing standards, SOPs and templates.

Skills

Medical writing

Regulatory writing

BLA writing

Clinical trial documentation

Education

MD/PhD or equivalent

Job description

Senior Medical Writer - Scientific & Regulatory

About the Role

An innovative biotechnology organisation is seeking an experienced Senior Medical Writer to support the development of novel therapies, particularly across oncology and immunology.

You will be responsible for authoring and reviewing scientific and regulatory documentation throughout the drug development lifecycle, working closely with clinical, regulatory and research teams.

Key Responsibilities

• Author and review clinical and regulatory documents, ensuring scientific accuracy and regulatory compliance.
• Independently draft and update Clinical Trial Protocols and Clinical Study Reports (Phase I-III).
• Prepare Investigator's Brochures, CTD modules, DSURs, Annual Reports and Risk Management Plans.
• Contribute to BLA submissions and regulatory response documents.
• Review scientific and R&D reports.
• Coordinate document reviews, approvals and external medical writing activities.
• Support medical writing standards, SOPs and templates.

Requirements

• MD, PharmD, PhD or equivalent scientific degree.
• Minimum 5 years' medical/scientific writing experience within biotech or pharma.
• Strong hands-on experience with BLA writing.
• Proven experience authoring Clinical Trial Protocols and CSRs.
• Experience with clinical regulatory documentation and Phase I-III trials.
• Knowledge of ICH guidelines, FDA requirements and EU CTR.
• Oncology and/or immunology experience highly desirable.
• Native-level written and spoken English.