Job Opportunity for Graduates at GSK

Overview:

GSK is hiring an experienced Standards & compliance Manager at their Bangalore location. As a Scientific & Medical Writing Director, you will be responsible for applying scientific and operational expertise, and leadership in a matrix organization to design and deliver high quality, fit for purpose clinical documents and key organizational process improvements relating to clinical documents including submissions.

The complete details of this job are as follows:

Roles and Responsibilities:

The Ideal Candidate should be able to:

• Effectively lead matrix team in the delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with standards and global/ regional/local regulatory requirements.
• Accountable for developing and implementing plans for document delivery and/or lifecycle.
• Lead medical writing aspects of review of reporting and analysis plans and provides critical input on required tables acting as key contributor to regulatory responses as necessary.
• Implement strategies to manage implications and risk on clinical submission timelines, budgets and goals.
• Motivate, influence, advocate for and manage direct reports, complementary staff, contract workers, other team members and senior stakeholders to effectively contribute to and review documents.
• Promote environment for others to generate ideas for improvement and champions improvements in technology and ways of working.
• Lead development of training materials for therapeutic area scientists and provide mentoring and/or training on clinical documentation and submission planning to individuals or teams.
• Identify need for external resource support, negotiate timelines and cost with external medical writing vendors/Clinical Research Organizations (CROs).
• Prioritize effectively managing multiple deadlines across multiple project teams successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix teams.

Basic Qualifications:

• They are looking for professionals with these required skills to achieve our goals:
• Bachelor’s degree
• Experience leading medical writing projects or programs
• Experience leading activities or components of a project/program to meet business and regulatory submission needs
• Scientific or medical writing experience specifically within the biotech/pharmaceutical industry

Preferred Qualifications:

• If you have the following characteristics, it would be a plus:
• Advanced Degree in Life Sciences
• Excellent verbal and written communication skills
• Ability to work independently and make decisions with minimal supervision
• Proven ability to influence and negotiate with key internal and external stakeholders or partners

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