Eli Lilly Data Entry Jobs Work From Home

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Industry: Private
Employment Type: Full Time
Work Hours: 8
Salary: £35 – £45Hour
Location: United Kingdom
Company: Eli Lilly

Description:

Eli Lilly Data Entry Jobs Work From Home

Purpose:

The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to the global regulatory strategy (i.e. RSD) and ensure local regulations and region/country business needs are included.

The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist is accountable to provide regional regulatory leadership and oversight in delivering high quality and efficient regulatory submissions, approvals, and local labelling for their assigned product(s). The Senior Director/Executive Director is responsible for leading meetings and other interactions with region/country regulators.

The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA Regional Regulatory Scientist performs regulatory evaluations of external business opportunities, as requested by management, and effectively manages alliance/CRO relationships in regulatory area.

Eli Lilly Data Entry Jobs Work From Home

Primary Responsibilities:

Regulatory Expertise for Assigned Program/Product(s) in Region/Country

Provide region/country input and review of global strategic plans and global/regional submission plan and documents.
Contribute during key governance committees on regional regulatory strategy decisions, if requested (e.g. when key discussion topics impact the region).
Ensure approval and delivery of content for local regulatory submissions, engaging cross functional partners in contributing to development of submission content.
Own relationship and lead meetings and interactions with regulators in assigned region and engage cross functional partners to contribute to regulator interactions. Influence the regulator in favor of the planned development.
Lead development of local/regional labelling strategy (product information and packaging) and network for alignment across region/affiliate team to enable timely completion of registration milestones (i.e. submission, approval, and launch). Apply labelling expertise, competitor knowledge, and regulatory precedent to propose labelling content to influence commercially viable labelling in region/country. Lead team during negotiation with regulators by providing responses to labeling questions.
Ensure compliance with all applicable regulations and internal quality systems.
Provide up-to-date expertise on regional registration procedures.
Interpret and anticipate impact of new guidelines and initiate change in response to changing environment.
Own all regulatory activities in support of assigned marketed product(s) in the region/country.
Be involved in medical device/in-vitro diagnostics regulatory activities and to potentially serve as, or perform the responsibilities of, the medical device UK Responsible Person or EU Authorized Representative in accordance with applicable UK or EU legislation, respectively, and the associated internal Quality Agreement(s).
Ensure the registration needs for local patients in clinical trials are met for countries in the region/country

Eli Lilly Data Entry Jobs Work From Home

Lead, influence and partner

Partner with Global Regulatory Leads to help solve development and regulatory issues impacting local registrations and when engaging with relevant business unit and development team on assigned programs/products.
Partner with Global Regulatory Leads to ensure a robust regulatory and submission sequencing strategy is developed, endorsed, and executed for countries in assigned region.
Liaise with the affiliates to anticipate region/country specific issues, impact of labelling on promotion, pricing and reimbursement.
Participate in regional meetings (commercial managers, medical directors) to ensure that regulatory strategy and issues are considered and to learn about their needs.
Participate in forums that share regulatory information across GRA components and other Lilly teams and business partners.
Propose continuous improvement projects to simplify processes and increase productivity of work executed by affiliates and GRA
Lead or represent the regulatory function on cross-functional non-product related projects
Serve as a mentor for GRA personnel.
Exemplify Team Lilly behaviors: Include, Innovate, Accelerate, and Deliver in internal and external interactions.
Model the innovation, leadership behaviors and regulatory excellence attributes as described in Global Regulatory Affairs white papers.
Constructively challenge teams to reach the best solutions to issues.
Create and lead in an environment of equity and inclusion that encourages open discussions on issues to achieve a robust outcome on business decisions.

Eli Lilly Data Entry Jobs Work From Home

Minimum Qualification Requirements:

Advanced scientific degree (i.e., PhD, MD, PharmD) or bachelor’s with significant relevant industry-related experience in regulatory affairs and/or drug development
Industry-related experience in regulatory affairs and/or drug development experience
Knowledge of local/regional regulatory procedures and practices
Awareness of evolving regulatory reform initiatives, preferred
Demonstrated knowledge of the integrated drug development process and Lilly’s (or external peer company) regulatory/business strategies
Demonstrated ability to find solutions and alternatives through teamwork embracing diversity, equity and inclusion resulting in positive business outcomes
Demonstrated ability to assess and manage risk in a highly regulated environment
Strong written, spoken and presentation communication
Demonstrated negotiation and influence skills
Demonstrated attention to detail

Eli Lilly Data Entry Jobs Work From Home

About the Eli Lilly Company :

Eli Lilly, a renowned pharmaceutical company, has made significant strides in the United Kingdom’s healthcare landscape. With a history dating back to 1876, Eli Lilly has established itself as a global leader in the development and production of innovative medicines.

In the UK, Eli Lilly operates as an integral part of the healthcare ecosystem, focusing on research, development, and distribution of medications to address various medical conditions. The company’s commitment to innovation is reflected in its diverse portfolio, spanning therapeutic areas such as diabetes, oncology, neuroscience, and immunology.

One of Eli Lilly’s notable contributions to the UK healthcare system is its dedication to addressing unmet medical needs. Through ongoing research and development efforts, the company strives to bring forward novel treatments that improve patient outcomes and quality of life.

Moreover, Eli Lilly emphasizes collaboration with healthcare professionals, academic institutions, and government agencies to foster a comprehensive approach to healthcare delivery. By engaging in partnerships and initiatives, the company aims to enhance access to healthcare services and promote health equity across diverse populations.

In addition to its focus on drug development, Eli Lilly prioritizes corporate responsibility and sustainability. The company is committed to ethical business practices, environmental stewardship, and community engagement initiatives that positively impact society.

Overall, Eli Lilly’s presence in the United Kingdom is characterized by its commitment to advancing healthcare through innovation, collaboration, and social responsibility. As the company continues to evolve and expand its footprint, its contributions to the UK healthcare landscape are poised to remain significant in the years to come.

Eli Lilly Data Entry Jobs Work From Home

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