Job description
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development. Our history includes the development of many innovative medicines, notably the discovery of the world's most widely-used treatment for Alzheimer’s disease. As we continue to expand, we are seeking highly-motivated individuals who want to work in a fast-paced environment and make a difference. If this is your profile, we want to hear from you.
Job Summary
The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers.
Essential Functions
Responsibilities Include but are not limited to:
- Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead
- Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material
- Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results
- Providing guidance to other medical writers applying industry and medical writing best practices
- With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports
- Contributing to the writing of marketing application submission documents
- Managing processes for obtaining feedback for improvements for the document standards and structure
- Providing mgmt. with appropriate information to ensure procurement of adequate and timely resources to complete medical writing deliverables
- At the Director's discretion, may provide work direction to contractors/consultants
- Contributing to process improvement within and across functional areas
- Influencing medical writing strategies and processes within and across functional areas
- Working with teams to develop project specific metrics compliant with standard project metrics
- Monitoring and evaluating project metrics, escalating issues as needed
Requirements
- Bachelor's Degree required; an advanced degree is preferred.
- Minimum of 5-8 years' medical writing experience in assigned therapeutic area, with specific experience with targeted compounds preferred
- Must have participated in a major marketing application submission
- Strong critical thinking and problem solving skills
- Self-motivated with the ability to influence others
- Ability to multitask
- Result driven with the ability to demonstrate time management and project planning
- Able to work on site
- Advanced working knowledge of MS project and MS Word
- Experienced in the use of a document management system
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Eisai requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under applicable law. This requirement is a condition of employment at Eisai, and it applies regardless of whether the position is located at an Eisai site, field based or is fully remote. If you are unable to receive the vaccine for qualifying medical reasons (including pregnancy-related), or religious reasons (sincerely held religious beliefs), you will have an opportunity to request a reasonable accommodation.
Eisai is an equal opportunity employer and as such, is committed in policy and in practice to recruit, hire, train, and promote in all job qualifications without regard to race, color, religion, gender, age, national origin, citizenship status, marital status, sexual orientation, gender identity, disability or veteran status. Similarly, considering the need for reasonable accommodations, Eisai prohibits discrimination against persons because of disability, including disabled veterans.
Eisai Inc. participates in E-Verify. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States. Please click on the following link for more information:
Right To Work
E-Verify Participation
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