Senior Medical Writer

Safeguard Global Recruiting; Dindigul; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Safeguard Global Recruiting in Tamil Nadu, India is seeking an experienced Medical Writer to represent the Medical Writing team and provide expert support to clients across clinical trial data, protocols and CSR projects. The role includes developing best practices and SOPs, enabling line management of staff, and helping to grow the medical writing service by winning new projects and improving processes.

A PhD in life sciences or related field and 3+ years in medical writing are preferred, with

Qualifications

• PhD in life sciences or related field; strong medical writing background.
• 3+ years medical writing experience in CRO/pharma or drug development.
• Fluent English, strong written and oral communication.
• Ability to develop SOPs and lead process improvements.
• Experience interpreting clinical data and presenting findings.

Responsibilities

• Represent the Medical Writing team to clients and customers.
• Assist in developing SOPs and best practices for projects.
• Provide line management to allocated staff within Medical Writing.
• Help grow the Medical Writing department by winning new projects.
• Drive and develop processes to support all Medical Writing activities.

Skills

Medical Writing

Life sciences background

English proficiency

Data interpretation / statistics

Leadership / team management

Regulatory knowledge

Software proficiency

Project management

Clinical trial knowledge

Education

PhD in life sciences or related field

Tools

EndNote

PowerPoint

Prism

Excel

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.