Senior Manager Medical Writing

Job Summary

The Senior Manager, Medical Writing (MW) will be responsible for leading and advising on medical writing processes and activities for individual asset teams to which they are assigned. The Senior Manager, MW will additionally contribute to the management of operational plans, budgets, and innovative solutions for all medical writing activities across OPDC. He/she will also lead or contribute to process improvements intended to increase project efficiency, quality, and the timely achievement of deliverables, and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide. He/she may also lead teams of medical writers to collaboratively prepare regulatory submission dossiers and/or directly manage the activities of contract writers or other contract roles within the MW team.

Job Description

• Represents MW on project/asset teams, including but not limited to attendance at team meetings, communication of document project status or risks/issues, and acting as an advisor for the asset team regarding MW activities, processes, and timelines.
• Leads teams of writers for a large multi-document project (eg, a regulatory submission), including resourcing, managing timelines, team coordination and collaboration, and issue management and escalation, if needed.
• Ensures MW activities meet quality standards and expectations and adhere to applicable corporate SOPs, WPs, policies, guidelines, and regulations.
• Provides training and communications to internal and external stakeholders regarding MW processes, best practices, and process improvements.
• Reviews new ICH and FDA guidelines regarding MW, evaluates their impact on the organization and makes recommendations on the need to develop and/or enhance SOPs and work processes.
• Leads or supports process or innovation initiatives within the MW team and/or represents MW in other departmental innovation initiatives.
• Provides relevant and timely project information to the Head of Medical Writing, including budget recommendations, ensuring that adequate coverage of MW tasks is maintained in accordance with the company's goals and objectives.
• Manages and/or provides mentorship of contract MW staff. Activities may include, but are not limited to, interviewing, hiring, training, and timesheet/contract management.
• Authors and/or edits key clinical or regulatory documents, as needed.

Qualifications/ Required

• BA/BS degree in a Life Science discipline
• 8+ years of medical writing experience at pharma/biotech/CRO companies
• Excellent project management and communication skills.
• Ability to work with cross-functional teams in highly matrixed team environment, collaborate with a wide variety of team members and relate effectively to people at all levels of the organization
• Ability to proactively escalate issues and provide solutions to problems.
• Expertise in ICH and electronic submission guidelines for regulatory documents
• Demonstrated experience in writing/developing clinical and regulatory documents for global submissions
• Expertise with electronic document management systems and other content authoring technologies
• Ability to identify needed process improvements and contribute to their implementation.
• Embraces change and has a flexible and innovative mindset
• Experience with training and/or mentoring less experienced medical writers
• Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook, Teams)
• Team player who demonstrates initiative, applies good judgment, and consistently maintains a positive attitude

Preferred

• Graduate degree (MS, PhD) in a Life Science discipline
• Previous experience with managing/supervising other medical writers
• Member of a professional Regulatory or Medical Writing organization (eg, AMWA, DIA)

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

• Competencies
• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Minimum $146,955.00 - Maximum $219,650.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

Disclaimer:  

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

Statement Regarding Job Recruiting Fraud Scams

At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives.  They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.

Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.

Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.

To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities.  All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property.  No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.