Role Description: The Medical Writer authors scientific documents including but not limited to protocol, clinical study reports, inform consent forms, clinical modules (2.5 and 2.7 summaries), lay summaries, CSR narratives, Investigator's brochure etc.

Principal Accountabilities

Write and review the above mentioned documents: study protocol, clinical study reports, inform consent forms, clinical modules (2.5 and 2.7 summaries), lay summaries, CSR narratives, Investigator's brochure, Briefing books and/ or anonymization activities (EMA Policy 0070)

- If required and as applicable, manage some of the sub-contracted medical writing activities with offshore team

- Liaise with sponsor project managers, data managers, statisticians to deliver high quality results as appropriate. Coordinates for document authoring, review and approval (end-to-end activities).

- Demonstrate knowledge of assigned therapeutic areas and assigned products.

- Have basic knowledge of key statistical concept.

- Ability to compare and interpret data across different MAA, and its logical representation.

- Research, develop and write content that is scientifically accurate, evidence-based, grammatically accurate, referenced using appropriate sources, and consistent with quality standards.

- Be able to clearly communicate medical scientific concepts in a condensed way.

- Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed.

- Interpret and apply clinical data in medical communication deliverables

- Responsible for consistency, checks documents for data errors and uniformity with source documents.

General Requirements

- Well-versed with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and regulatory requirements for scientific documents

- Strong English writing capabilities

- Solid medical/ scientific knowledge in any of Oncology, Inflammatory, Rare Diseases, neuroscience and cardiovascular therapeutic areas

- Autonomy

- Excellent oral English communication skills

Qualifications, Skills and Experience

Master degree, preferably in life sciences, chemistry or engineering (biotechnology/bio-informatics)

- A postgraduate qualification in life sciences discipline is desirable although not essential

- Experience of developing positive, credible and lasting relationships with senior level managers, and clinical teams

- Demonstrable analytical, interpretative and problem-solving skills, the ability to simplify all research procedural communications to the variety of research roles is essential

- Scientific writers require deep understanding of regulations governing research conduction, as well as of the respective governing bodies (FDA or EMA) for content development.

- Strong capability in managing projects and juggling priorities so that deadlines are met while retaining consistently high-quality outcomes

- 4+ years medical report writing experience

- Excellent conversational and business English (written and oral)

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