Senior Medical Writer

Safeguard Global Recruiting; Krishnagiri District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Safeguard Global Recruiting seeks a Medical Writing leader with a PhD in life sciences, medicine, or a related discipline. The role includes representing the Medical Writing team, developing SOPs, and line-managing staff within the department.

The candidate will help build the Medical Writing Department, win new projects, and drive process improvements to support all Medical Writing activities.

Qualifications

• 3+ years of Medical Writing experience in CRO/Pharma/biotech or drug-development environment.
• Experience writing on Protocols and CSR across clinical trial phases.
• Ability to read, analyse, and interpret scientific/technical journals.

Responsibilities

• Represent the Medical Writing team and provide expert Medical Writing support to clients and customers.
• Assist in developing SOPs and best working practices for projects.
• Provide line management to allocated staff within the Medical Writing Department.
• Help build the Medical Writing Department and drive growth of the service offering.
• Develop processes to support all Medical Writing activities.

Skills

Excellent written communication

Fluent English

Cross-functional collaboration

Education

PhD in life sciences/medicine/pharmacy

Tools

Adobe

EndNote

MS Office

Prism

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.