Eisai
Associate Director, Medical Writing
Eisai, Princeton, New Jersey, us, 08543
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 Associate Director, Medical Writing will be the designated Lead Medical Writer for multiple Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy, and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Independently prepares and at times may direct the writing of PCSs, protocols, and protocol amendments. Independently prepares and at times may direct all the writing of the CSRs including narratives. Works across functional areas to obtain all applicable source materials. Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports. Leads the medical writing activities for marketing application submission documents. Liaises with other functional areas and groups in the development of document standards and structure. Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design and results across the program. Implements document quality controls, standards, and best practices. Requirements
BS required/MS preferred. Minimum of 8-10 years medical writing experience in an industry setting, with specific experience with therapeutic area. Must have participated in or lead a major marketing application submission. Strong critical thinking and problem-solving skills. Self-motivated with the ability to influence others. Ability to multitask on complex projects. Result-driven with a mastery of 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 Documentum system. Eisai Salary Transparency Language: The base salary range for the Associate Director, Medical Writing is from $149,200 - $195,800. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit
here . 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
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E-Verify Participation
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The Associate Director, Medical Writing will be the designated Lead Medical Writer for multiple Programs, responsible for providing needed support and direction to other staff/contractors on these programs. As the lead writer, the incumbent ensures timely completion, accuracy, and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions
Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Independently prepares and at times may direct the writing of PCSs, protocols, and protocol amendments. Independently prepares and at times may direct all the writing of the CSRs including narratives. Works across functional areas to obtain all applicable source materials. Leads the preparation of clinical sections of submission documents, such as the briefing books, Global Investigator Brochures, and annual regulatory reports. Leads the medical writing activities for marketing application submission documents. Liaises with other functional areas and groups in the development of document standards and structure. Interacts routinely with clinical research and biostatistics staff to gain comprehensive understanding of the study design and results across the program. Implements document quality controls, standards, and best practices. Requirements
BS required/MS preferred. Minimum of 8-10 years medical writing experience in an industry setting, with specific experience with therapeutic area. Must have participated in or lead a major marketing application submission. Strong critical thinking and problem-solving skills. Self-motivated with the ability to influence others. Ability to multitask on complex projects. Result-driven with a mastery of 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 Documentum system. Eisai Salary Transparency Language: The base salary range for the Associate Director, Medical Writing is from $149,200 - $195,800. Under current guidelines, this position is eligible to participate in Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term Incentive Plan. Final pay determinations will depend on various factors including but not limited to experience level, education, knowledge, and skills. Employees are eligible to participate in Company employee benefit programs. For additional information on Company employee benefits programs, visit
here . 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
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E-Verify Participation
#J-18808-Ljbffr