Senior Medical Writer

Safeguard Global Recruiting; Thoothukudi; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Safeguard Global Recruiting seeks a PhD-level Medical Writer to lead and support client projects across the Medical Writing portfolio. The role includes line management, developing SOPs, and expanding the Medical Writing department to win new work.

The candidate will provide expert writing support, interpret clinical data, and help implement best practices, ensuring high-quality deliverables across trial phases and therapeutic areas.

Qualifications

• PhD in life sciences, medicine, pharmacy or a related discipline.
• 3+ years of Medical Writing experience in CRO/Pharmaceutical/Biotech settings.
• Fluent in English with excellent written and oral communication.
• Experience interpreting clinical data and literature.
• Ability to write peer-reviewed articles in prescribed formats.
• Strong time management and leadership capabilities.
• Knowledge of drug development and regulatory frameworks.
• Ability to lead process development and cross-functional collaboration.

Responsibilities

• Represent the Medical Writing team and provide expert support to clients.
• Help develop SOPs and best practices for project delivery.
• Provide line management to Medical Writing staff.
• Assist in building the Medical Writing Department within the business.
• Drive processes to support all Medical Writing activities.

Skills

Medical Writing

Team Leadership

Scientific Analysis

Written Communication

English Proficiency

Data Interpretation

Regulatory Knowledge

Peer-Reviewed Writing

Education

PhD in life sciences, medicine, pharmacy or related discipline

Tools

Adobe

EndNote

MS Office

Prism

Bibliographic software

Internet software

Job description

Mandatory Requirement : PhD in life sciences, medicine, pharmacy or a related discipline.

FOCUS OF THE JOB:

• To represent the Medical Writing team and provide expert Medical Writing support to client and its customers.
• To assist in developing best working practices and Standard Operating Procedures in delivering the portfolio of projects within the Medical Writing Department.
• Able to provide Line Management to allocated staff within the Medical Writing Department.
• To assist in building the Medical Writing Department within the business; act as a client facing representative, winning new projects and assisting in the continued growth of the medical Writing service offering.
• Help to drive and develop the processes to support all Medical Writing activities.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

• Level, preferably in life sciences, medicine, pharmacy or a related discipline.3+ years of prior Medical Writing experience within the CRO/Pharmaceutical/Biotech industry or within a drug-development environment, working on Protocol and CSR projects across all clinical trial phases and a variety of therapeutic areas.
• Passion for science and healthcare.
• Excellent computer skills including knowledge of Adobe, Internet software, Spreadsheet software, Word Processing software, Graphics software (eg, PowerPoint or Prism), Bibliographic software eg, EndNote) and any other applicable software.
• Experience of reading, analysing, and interpreting common scientific and technical journals.
• Experience of interpreting and presenting clinical data and other complex information.Excellent oral and written communicative skills. Fluent in oral and written English.
• Ability to understand mathematical concepts e.g. probability and statistical inference.
• Ability to write articles for peer-reviewed publications that conform to the prescribed style and format.
• Excellent time management to organise and prioritise workload and those of any Medical Writing Department team members under their supervision (if applicable).
• Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
• Ability to work in a collaborative team environment.
• Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise. Encourage and support team members to apply the same approach to seek solutions.
• Knowledge of drug development process including the relationship between the CRO industry and Pharmaceutical companies.
• Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
• Knowledge of clinical trial process; including the interaction between the Medical Writing team with the wider Biometrics team and Clinical Operations.

Desired Skills/Experience

• PhD in life sciences, medicine, pharmacy or a related discipline.
• 5+ years of prior Medical Writing experience within the CRO/Pharmaceutical/Biotech industry or within a drug-development environment, working on Protocol and CSR projects across all clinical trial phases and a variety of therapeutic areas.
• An awareness of clinical database applications, which may include (but not limited to) Medrio, Oracle Clinical, Medidata, SAS.
• Familiarity with Medical Dictionary Coding.