Senior Medical Writer

Safeguard Global Recruiting; Thane; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Safeguard Global Recruiting is seeking a PhD-qualified Medical Writer to represent the Medical Writing team and provide expert support to clients and customers. The role includes developing SOPs, leading staff within the department, and helping to build the Medical Writing practice through new project opportunities.

Applicants should have 3+ years of Medical Writing experience in CRO/pharma or drug development, strong English communication, and solid skills in data interpretation and regulatory

Qualifications

• PhD in life sciences, medicine, pharmacy or related discipline.
• 3+ years of prior Medical Writing experience within CRO/Pharmaceutical/Biotech industry or drug-development environment.
• Fluent in English, excellent written and spoken communication.
• Experience reading, analysing, and interpreting scientific literature.
• Ability to interpret and present clinical data and other complex information.
• Ability to lead by example on process development and team objectives.
• Knowledge of drug development process and regulatory frameworks.

Responsibilities

• Represent the Medical Writing team and provide expert Medical Writing support to clients and its customers.
• Assist in developing best practices and SOPs for the Medical Writing portfolio.
• Able to provide Line Management to allocated staff within the Medical Writing Department.
• Assist in building the Medical Writing Department within the business; act as client facing representative and help win new projects.
• Help to drive and develop processes to support all Medical Writing activities.

Skills

Medical Writing expertise

Clinical data interpretation

Team leadership

Regulatory knowledge

Communication skills

Analytical thinking

Risk management

Education

PhD in life sciences/medicine/pharmacy

Tools

Adobe products

EndNote

Medrio

Oracle Clinical

Medidata

SAS

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.