**Job Summary** Otsuka seeks a highly skilled and motivated R&D paralegal to join our legal team. The ideal candidate will have a strong background negotiating agreements related to pre-clinical and clinical research (international experience a plus) in the pharmaceutical/biotech industry. The R&D Paralegal will possess excellent organizational, management, and interpersonal skills, and will provide legal support and assistance for various R&D and regulatory-related activities. This role requires frequent interaction with leadership and other stakeholders from multiple cross-functional teams. This position is located in either Princeton, NJ or Rockville, MD. No matter where the role is located, up to 20% travel within the US is required based upon business needs. The R&D Paralegal will report to the Senior Director, Corporate Counsel in the Global Regulated Environments (GRE) Practice Group in the Laws, Regulations, and Business Optimization Department, and will play an important role in the team’s efforts to develop, implement and execute R&D support strategies. Key responsibilities will include assisting with contract negotiation and management, legal/regulatory research, and internal data tracking management. The R&D Paralegal must be able to work independently as well as with teams, and will lead and support change at all levels, including with vendors, executives, in-house attorneys, support staff and other key stakeholders within the Company. **Job Description** **Global Clinical Management & Clinical Development Paralegal Functions:** + Review, interpret, and negotiate various clinical study-related and quality study-related agreements such as confidentiality disclosure agreements, powers of attorney, letters of authorization, and clinical trial agreements + Support review and negotiations of Informed Consent Forms in connection with U.S. and global clinical trials, including the ability to effectively liaison with internal and external privacy law experts on relevant legal requirements + Drive increased efficiency, coordination, and effectiveness of R&D material review processes and support to meet the needs of the business and other key stakeholders + Utilize strong business acumen and legal expertise to proactively identify, analyze, and navigate potential legal and compliance issues and risks associated with contract terms and other activities within areas of responsibility, and work with attorneys to formulate and communicate compliant and practical solutions that meet business objectives + Communicate with business partners regarding the risks presented by contract terms and possible strategies to mitigate such risks + Assist with fact-gathering to support legal advice + Develop and deliver presentations and training on R&D legal and contracts-related topics as needed + Establish strong business partnership relationships characterized by a high level of collaboration, trust, and mutual respect + Support development and implementation of contract playbooks (including for non-disclosure agreements, clinical trial agreements, and other high-volume agreement types), templates, and processes + Review study start-up documents including patient recruitment materials and indemnification letters **Medical Affairs Paralegal Functions:** + Independently review, revise, and approve disease state education content for legal risk as part of the Medical Review Committee + Independently review and approve disease state table exhibits **General Paralegal Functions:** + Assist attorneys in reviews of other documents, as assigned + Accompany attorneys to meetings and conference calls to capture meeting minutes and record action items; follow up on action items with attorneys to ensure they are addressed and resolved + Perform basic legal research and prepare memoranda regarding diverse areas of law + Prepare, facilitate, and administer letters, emails, and other related documents, ensuring accurate grammar, spelling, content, and business formats, to internal and external parties + Maintain correspondence, project files and confidentiality of highly sensitive company information. + Prepare and maintain legal department documents and corporate records + Assist with the creation, organization and maintenance of litigation, legal and corporate files + Interact with business units as necessary to obtain documents and information relevant to matters involving or affecting the company + Track contract negotiations and propose contract modification Perform other legal, administrative and corporate duties upon request. **Qualifications** Required **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. **Education / Experience** **EDUCATION:** + Associate’s Degree or higher and Paralegal Certificate required **EXPERIENCE:** + 3-5 year’s paralegal work experience, pharmaceutical industry preferred + Demonstrated experience with contract negotiations required + Strong knowledge of issues related to clinical research and commercialized products + Must be client service oriented, can handle stressful situations with tact and friendly personable attitude + Dedicated to prompt, thorough and relevant responses to department members and clients, with appropriate planning and follow-up as needed + Self-motivated and capable of working both independently and as part of a team + Superior organizational skills; able to effectively manage multiple projects and responsibilities by applying strong prioritization skillset and sound judgment + Demonstrated ability to work accurately and effectively in a detail- and results-oriented environment. + Strong written communication and editing skills required + Proven ability to exercise discretion and maintain strict confidentiality in all matters + Excellent computer skills, including mastery of Microsoft Office **\#LI-PG1** **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 $104,640.00 - Maximum $149,600.00, 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, 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 (EEAccommodations@otsuka-us.com) . **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.