This listing was posted on HireLifeScience.
Senior Manager, Medical Writing
Location:
Remote
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 Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead Lead project management for medical writing deliverable by defining milestones, managing budget, resources and timelines, developing metrics etc. Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material Collaborate with cross functional teams like Clinical Research, Biostatistics, Statistical programming, Clin Ops. etc. to ensure alignment on program objectives, facilitate document reviews, proactively resolve any issues etc. With minimal supervision, preparing and/or reviewing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports Prepare and review marketing application submission documents At the Director's discretion, may provide work direction to vendors/ contractors/consultants Contributing to process improvement within and across functional areas by obtaining feedback for improvements for document processes, standards, and structure Championing medical writing strategies and processes within and across functional areas Continuously work towards improving medical writing capabilities within own area by improving systems/ tools and providing training Monitoring and evaluating project metrics, escalating issues as needed Requirements Bachelor's Degree required; an advanced degree in science or related areas is preferred. 8+ years of experience in pharma or related industry OR equivalent combination of education and experience Experience writing/reviewing clinical regulatory documents and submissions for own area of study/ program/ marketing application, with direction Experience managing multiple projects by creating plans for budget, resources, milestones and collaborating with cross functional teams to drive accountabilities Experience in vendor management Proven performance in earlier role/comparable role Strong critical thinking and problem solving skills Self-motivated with the ability to influence others Able to attend on site meetings as necessary Advanced working knowledge of MS project and MS Word and Experienced in the use of a document management system #LI-HC1#IND-123 Eisai Salary Transparency Language: The base salary range for the Senior Manager, Medical Writing is from :126,300-165,800 Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual 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 https://us.eisai.com/careers-at-eisai/benefits .Certain other benefits may be available for this position, please discuss any questions with your recruiter.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
Company:
Eisai
Posted:
April 10 on HireLifeScience
Visit Our Partner Website
This listing was posted on another website. Click here to open: Go to HireLifeScience
Important Safety Tips
- Always meet the employer in person.
- Avoid sharing sensitive personal and financial information.
- Avoid employment offers that require a deposit or investment.
To learn more, visit the Safety Center or click here to report this listing.