Senior Medical Writer

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

Job summary

Safeguard Global Recruiting is seeking an experienced Medical Writer leader with a PhD to represent the Medical Writing team, provide expert support to clients, and help develop best practices and SOPs for project delivery.

You will lead allocated staff, help grow the Medical Writing department within the business, act as a client-facing representative to win new projects, and drive process improvements across all Medical Writing activities.

Qualifications

• PhD in life sciences or related discipline.
• 3+ years medical writing experience in CRO/pharma/biotech drug development.
• Fluent in English with excellent written and verbal communication.
• Ability to read, analyze and interpret scientific/technical journals.
• Experience in interpreting and presenting clinical data and complex information.
• Ability to lead by example in process development and team objectives.

Responsibilities

• Represent 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 and win new projects.
• Drive processes to support all Medical Writing activities.

Skills

Medical Writing

Line management

SOP development

Client-facing

Risk mitigation

Scientific writing

English proficiency

Data interpretation

Biostatistics awareness

Education

PhD in life sciences/medicine/pharmacy

Tools

Adobe

EndNote

PowerPoint

Prism

SAS

Medrio

Oracle Clinical

Medidata

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.