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Medical Writing Optimization Lead

GSKTokyo Head

21 days ago

Job description

Job Purpose

The Medical Writing Optimization Lead is responsible for driving innovation, enhancing capability development, and managing capacity within the Asia medical writing team. This role will focus on optimizing processes, improving efficiencies, adopting digital solutions and ensuring the team is equipped with the necessary skills and resources to meet the evolving needs of the organization. The ideal candidate will have a strong background in medical writing, a passion for innovation, and proven experience in leadership and strategic planning.

Key Responsibilities

Identify, prioritize and implement innovative solutions to improve the quality and efficiency of medical writing processes.
Stay abreast of industry trends, emerging technologies, and best practices to drive continuous improvement.
Collaborate with cross-functional teams to integrate new tools and technologies into the medical writing workflow
Assess the current capabilities of the medical writing team and identify areas for development.
Design and facilitate training programs to enhance the skills and knowledge of team members.
Foster a culture of continuous learning, digital fluency and professional growth within the team.
Monitor and manage the workload of the medical writing team to ensure projects are completed on time and within budget.
Develop and implement resource allocation strategies to optimize team productivity.
Collaborate with project managers and other stakeholders to forecast future capacity needs and plan accordingly.
Provide guidance, mentorship, and support to medical writers, fostering a collaborative and high-performing team environment.
Establish dashboard and drive the continuous performance improvement.
Lead by example, demonstrating a commitment to excellence and continuous improvement.
Evaluate existing medical writing processes and identify opportunities for optimization.
Develop and implement standardized procedures and best practices to enhance efficiency and consistency.
Track and report on key performance metrics to measure the impact of process improvements.

Qualifications :

Masters or equivalent expertise (e.g. life science, medical, pharmacy)

8 years’ extensive experience in medical writing, with a proven track record of successful project delivery in the pharmaceutical industry, and demonstration of leadership

Must have expert knowledge of regulatory requirements and guidelines to ensure that all tools, processes, and outputs meet the highest standards of compliance. Used to develop and implement AI / digital tools and processes that ensure consistency and compliance across all medical writing activities. The lead also provides guidance and facilitate the training to the medical writing team to maintain adherence to these regulations.

Proficiency in data analytics and reporting tools is essential for the Medical Writing Optimization Lead to assess and improve the efficiency and effectiveness of medical writing processes.

To analyze performance metrics, identify bottlenecks, and generate reports that inform strategic decisions. The lead uses data analytics to monitor the quality and timeliness of document production, ensuring that resources are optimized, and improvements are continuously made.

Must stay abreast of innovative practices, technologies, and methodologies to drive continuous improvement in medical writing processes.

To introduce and integrate new tools and technologies (e.g., artificial intelligence, machine learning, and advanced document management systems) that enhance the efficiency, accuracy, and quality of medical writing. The lead also fosters a culture of innovation within the team, encouraging the exploration and adoption of new approaches that can streamline workflows and improve outcomes.

Ensures that medical writing processes are highly efficient, compliant, and capable of producing high-quality documentation. This role plays a critical part in optimizing resources, reducing time-to-market, and maintaining the company's competitive edge in the pharmaceutical industry.

Agility to respond quickly to changes in the asset strategy that impact Medical Writing processes and content

Risk mitigation (e.g., unforeseen competing priorities [e.g., due to acceleration or delays] for strategic and regulatory goals) and finding solutions to resolve issues and evolve.

Cross-functional collaboration to innovate practices and procedures across platforms.

Complexity of Problems : address issues related to regulatory compliance across multiple regions. This involves understanding and integrating diverse guidelines into a unified process that meets all requirements.

Judgment and Analysis : analyze the data to identify the root cause and determine the best course of action to resolve it.

Optimization of Processes : identify and implement process improvements to enhance the efficiency and quality of medical writing. This could involve adopting new technologies or refining existing workflows.

Stakeholder Coordination : Coordinate with cross-functional teams, such as clinical, regulatory, and quality assurance, to address and resolve issues that arise during the document development process.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory / immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

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