Job details

Director, Medical Writing, Oncology

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.

The Director, Medical Writing will be the designated Lead Medical Writer for multiple programs, responsible for key document preparation and 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 drug life cycle. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the drug/program to ensure alignment and consistency across the projects. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. The incumbent will also provide direct input to project budgets, as needed, and drive the establishment of process, standards, and timely completion of high-quality deliverables. This is not a people management position, but the incumbent will oversee the work of medical writers.

Responsibilities

Lead and manage multiple medical writing programs by authoring/reviewing high-quality clinical and regulatory documents including submission documents of various types, e.g., study or program level.
Implement medical writing/document strategy and goals with internal/ external teams, for accomplishment of critical milestones across programs.
Drive resource planning and process development within the department in line with strategic priorities
Act as medical writing expert and provide strategic support/ insights to cross functional teams/leaders.
Regularly evaluate the gaps in medical writing processes and talent capabilities and continuously work with the head of the department towards upgrades/ improvements.
Assist in the evaluation and selection of strategic medical writing vendors while ensuring synergies and operational efficiency.
Oversee document preparation by others, providing feedback and coaching.
Ensure deliverables are clearly defined within teams, important information is cascaded effectively with accountability driven throughout the organization.

Qualifications

Bachelor's or advanced degree in science or related area with significant experience in medical writing in pharma; Oncology experience is desirable.
Experience writing/reviewing/editing multiple types of clinical and regulatory documents including for submissions (e.g., study level, program level, health authority responses, marketing applications)
Experience managing the medical writing activities for multiple original and supplemental licensing applications (NDA, BLA, MAA, CTD) or equivalent submissions (IND, End of Phase 2)
Experience translating strategy into operational goals, vendor management, and resource allocation.
Strong organizational, interpersonal, and written communication skills. Must be able to communicate effectively in large or small group settings and work effectively with remote, global teams. Expert influence and relationship management skills required. Experience building internal/ external networks, effectively communicating with cross functional stakeholders, and contributing as thought leader in own area.
Experience leading teams with direct or indirect reporting
Proven performance in earlier role/comparable role

#LI-HC1

#IND-12

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

Eisai Glassdoor Company Review

3.5