The Senior Medical Writer is a writing-based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes 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.
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Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.
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Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents.
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Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator's Brochures [IBs], annual reports, HA briefing packages and response documents, submission summary modules, and integrated data summary reports).
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Adheres to medical writing practices/systems/tools to support clinical studies in order to meet company goals and objectives.
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Assures that standardized practices are implemented and maintained across all therapeutic areas.
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Engages with team members to ensure medical writing continues to deliver value to the business.
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Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.
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Supports innovation initiatives within the Medical Writing Group.
Required:
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Minimum of a BA/BS in Life Science
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7 years pharmaceutical/biotechnology experience related to clinical research
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Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
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Ability to interpret and organize scientific and clinical data
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Medical writing experience in Pharma, Biotech and/or CRO
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BA/BS + 7 years; MS/PhD + 4 years
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Experience with ICH and electronic submission guidelines for regulatory reports.
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Excellent written and verbal skills
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Good leadership, communication, and influencing skills
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Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
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Ability to identify process improvements, manage change successfully, work with newer technologies, and foster an innovative atmosphere
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Applies good judgment and demonstrates initiative to resolve issues
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Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
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Ability to function in an ambiguous environment
Preferred:
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Medical device experience
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Experience with electronic document management systems and other content authoring technologies
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Graduate degree
Our Benefits:
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Comprehensive medical, dental, vision and prescription drug coverage
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Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance
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Tuition reimbursement
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401(k) match
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PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits
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 $90,960.00 - Maximum $130,130.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.
Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, 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
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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.
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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:
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