Senior Medical Writer

Safeguard Global Recruiting; Kolhapur District; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

Safeguard Global Recruiting is seeking a senior Medical Writer with a PhD in life sciences, medicine, or pharmacy to lead the Medical Writing Department and provide expert support to clients and customers.

The role includes developing best practices, creating SOPs, and mentoring allocated staff while helping grow the service offering. The ideal candidate has 5+ years of MW experience in CRO/Pharma and strong English communication.

Qualifications

• PhD in life sciences, medicine, pharmacy or a related discipline.
• 5+ years of Medical Writing experience in CRO/Pharma/biotech or drug development.
• Excellent written and oral English.
• Experience writing protocols and CSR across clinical trial phases.
• Ability to lead and develop SOPs and working practices.

Responsibilities

• Represent the Medical Writing team and provide expert support to clients.
• Assist in developing SOPs and best practices for project delivery.
• Provide line management to allocated staff within Medical Writing.
• Help grow the Medical Writing department and drive service growth.
• Develop processes to support all Medical Writing activities.

Skills

Medical Writing

Client facing

SOP development

Team leadership

Data interpretation

Education

PhD in life sciences/medicine/pharmacy

Tools

Adobe

EndNote

PowerPoint

Prism

Excel/Spreadsheet tools

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.