Medical director jobs in Piscataway, NJ - 983 jobs

Join BoldAge PACE and Make a Difference! Why work with us? A People First Environment: We make what is important to those we serve important to us. Make an Impact: Enhance the quality of life for seniors. Professional Growth: Access to training and career development. Competitive Compensation: Medical/Dental Paid Time Off 240 Hours Annually 401K with Match Life Insurance Tuition Reimbursement Flexible Spending Account Employee Assistance Program BE PART OF OUR MISSION! Are you passionate about helping older adults live meaningful, independent lives at home with grace and dignity? BoldAge PACE is an all-inclusive program of care, personalized to meet the individual health and well-being needs of our participants. Our approach is simple: We listen to our participants and their caregivers to truly understand their needs and desires. Medical Director JOB SUMMARY: The Medical Director provides general medical direction and supervision of the medical aspects of care for participants. The Medical Director is responsible for the delivery and oversight of participant care, clinical outcomes, implementation and oversight of the quality assessment and performance improvement program, development and maintenance of medical policies and procedures/standards and protocols. The Medical Director will provide direction and supervision to primary care physicians, nurse practitioners, nursing staff and allied health services and leadership of the program among staff, colleagues and providers in the community. Any PCP Nurse Practitioners will practice collaboratively with the Medical Director or PCP Physician. Responsible for ensuring a managed care environment that utilizes resources efficiently and effectively. ESSENTIAL DUTIES AND RESPONSIBILITIES: Responsible for delivery of care and clinical outcomes. Provides medical guidance and supervision of medical services activities. Provides leadership and medical expertise in the development of medical policies, procedures and guidelines. Responsible for the development of PACE clinical standards and medical practice guidelines and protocols. Provides oversight of the QI Plan. Reviews all quality-of-care issues and oversees the development and implementation of quality of care corrective action plans. Participates in the oversight, training and education of the interdisciplinary team. Coordinates performance appraisal of the Primary Care Physician. Develops educational and other programs to build the skills of participating providers. In conjunction with Contract Manager manages all communication with the provider network Represents PACE to external agencies, professional groups and regulatory agencies and organizations as required. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. REQUIREMENTS: M.D. or DO with current state of license. DEA registration and the ability to obtain and maintain staff privileges at PACE contracted agencies. Board certified in Internal Medicine or Family Practice with advanced certification in geriatrics preferred. Must have experience working in a managed care environment and working with peers and other health providers to resolve utilization, quality management, performance improvement, pharmacy and therapeutics, peer review, credentialing, and physician leadership issues. Minimum 3 years of experience in a lead administrative role. 1 year of experience working with a frail or elderly population preferred. If this is not present, training on working with a frail or elderly population will be provided upon hiring. Must have reliable transportation, a valid driver's license, and the minimum state required liability auto insurance. Be medically cleared for communicable diseases and have all immunizations up to date before engaging in direct participant contact. Pass a comprehensive criminal background check that may include, but is not limited to, federal and state Medicare/Medicaid exclusion lists, criminal history, education verification, license verification, reference check, and drug screen. SKILLS AND ABILITIES: Excellent verbal, written and public speaking skills. Knowledge of physical, mental and social needs of frail older adults. Effective skills in physical assessment and chronic disease management for frail older adults. Able to work within the interdisciplinary team setting. Able to utilize basic computer skills in the workplace. Strong organizational skills. Demonstrates necessary skills and knowledge as outlined in position-specific competency requirements. Dependable, flexible and resourceful Able to work effectively and in a collegial manner will all members of the management and medical staff. Able to work sensitively and effectively with individuals of diverse ethnic and cultural backgrounds. BoldAge PACE provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Paid Time Off Includes seven holidays Match begins after one year of employment Full-Time Days Full- Time

Clinical Director VI - Full Time Woodhaven Family Wellbeing Center - Woodhaven, NY 11421 When you join the CCBQ Team, you will have an impact on the lives of many. For over 125 years, Catholic Charities Brooklyn and Queens has been providing quality social services to the neighborhoods of Brooklyn and Queens and currently offers 160-plus programs and services for children, youth, adults, seniors, and those struggling with mental illness. Our Clinics are community-based which offer a professional and welcoming environment for both clients and staff. The Clinics provide psychotherapeutic and psychopharmacological therapy, as well as individual, group, family therapy, crisis intervention, medication management, case management and collateral sessions. Our staff members follow an approach to health care that emphasizes wellness, recovery, trauma-informed care, and physical-behavioral health integration. Why you will enjoy being part of our team: 1. Competitive Salaries and Benefits 2. Professional Development (CEUs) 3. High Quality Supervision 4. Opportunities for Advancement STATEMENT OF THE JOB The Clinical Director VI will be responsible for overseeing the delivery of care in a behavioral health setting for a minimum of 1150 clients, in order to ensure the appropriateness and effectiveness of services, identification of gaps in service delivery system, representing the Agency at meetings, conferences and public forums, strategic planning and implementation, development and implementation of processes and services that will improve the service delivery system, program development - including monitoring revenue, productivity, outcomes, staff training and development and staff supervision, compliance with contracts, agency policies and procedures, regulatory requirements and audit readiness and new initiatives. The Clinical Director VI is expected to have regular interactions with other management staff within Integrated Health and Wellness and the other corporations in CCBQ to promote coordinated care and comprehensive service delivery. • Planning, coordinating, identifying, and implementing program outcomes and evaluation, strategic planning, accreditation efforts and program development. • Provide and/or oversee supervision of staff including ensuring coverage and supervision in situations which require 24 hour/7 day per week response. • Involvement in the RFP process, CQI initiatives and other grant initiatives as needed. • Participate in the Agency's response as it relates to the NYC designation of being a Tier One Response organization. • Participate in the development of appropriate program budgets and monitoring program adherence. QUALIFICATIONS • Master's Degree in a Human Service-related field from a nationally accredited institution. • Valid NYS LCSW. • Upon eligibility, obtain/retain Medicare UPIN credential and Managed Care Provider applications required for programs that bill 3rd party payers for services. • Three (3) years of supervisory experience • Experience in providing services to persons with psychiatric or cognitive disabilities or comparable experience. • The position requires a combination of skills in the following areas: administrative and clinical supervision and practice, design, operational oversight and evaluation of program services and staff, personnel management, budget development and control, property management, public relations, governmental relations, leadership development and team building skills. • Bilingual Spanish/English; Russian/English; Creole/English; Chinese/English; Korean/English speaking preferred. • Frequently lifts and/or moves up to 10 pounds. • Able to travel to multiple locations within the five boroughs as needed. • Able to work flexible hours and days - including weekends/evenings/holidays according to needs of program. BENEFITS We offer competitive salary and excellent benefits including: • Generous time off (Vacation/ Personal Days/ Sick Days/ Paid Holidays annually) • Medical, • Dental • Vision • Retirement Savings with Agency Match • Transit • Flexible Spending Account • Life insurance • Public Loan Forgiveness Qualified Employer • Training Series and other additional voluntary benefits. For more information on our organization, please visit our website at: ************ EOE/AA.

iHope Mission Statement: The iHOPE school community strives to provide comprehensive services for our students, who present with a variety of diagnoses including Traumatic Brain Injury, Acquired Brain Injury, and other brain-based disorders. Our students participate in academic instruction with appropriate modification and adaptation, as well as therapeutic services, based upon a collaborative, researched-based model that integrates current technology. iHOPE is committed to learners with complex needs and to their social, emotional, adaptive and educational advancement. Accessibility and integration into the larger community are at the core of our belief system. Key/Essential Functions & Responsibilities Directs all administrative work in the nursing department, including assisting with the formulation and implementation of new policies and procedures, in coordination with Director of Admissions and Family Engagement. Ensures compliance of the school health program with all local, state, and federal regulations; stays abreast of new and changing regulations. Establishes protocols for managing communicable diseases, assessing the school environment for safety and health risks and employing infection control measures; ensures appropriate notifications and coordinates with regulatory agencies as needed. Assists with the development, implementation, review, and/or modification of Health and Safety-related Standard Operating Procedures to support consistent and safe management of students' health needs while in the school's care and to address new and changing regulations. Makes recommendations for improvements or changes and leads implementation and communication of school health program initiatives, informing long-term goals for the department. Ensures adequate nursing staff at all times by participating in recruitment and selection of nursing staff, assigning duties, managing staff schedules and obtaining substitute nurses or providing coverage as needed. Supervises staff to ensure they are meeting students' health needs and assesses performance and quality of nursing services provided through ongoing staff supervision, observations and evaluations. Develops and facilitates appropriate training for nursing and other school staff regarding specialized care and procedures for individual students; may assist with training on other safety and health-related issues. Appropriately documents nursing department and health related activities including compiling and/or preparing, reviewing and/or maintaining accurate written nursing reports, immunization records, health and medical records, including employee new hire and/or annual physicals or forms and reporting of incidents, injuries, etc. Directs the implementation of individualized nursing care plans for each student and ensures or provides special health care and related services through assessment, intervention and follow-up for all children within the school setting, as needed. Collaborates with department directors and/or staff and attends classroom meetings for updates regarding students' health needs, as needed. Participates in student intake meetings, obtaining pertinent medical information from caregivers/parents including diagnoses, medications, emergency interventions and seizure action plans to develop appropriate nursing care plans. Provides direct nursing care including caring for sick and injured students or staff and administers medication or performs prescribed health care procedures according to students' needs and doctors' orders, as needed. Takes the lead in arranging appropriate courses of action for complex or significant health-related incidents and/or managing emergency medical situations involving students or staff. Provides families with health care related updates and information, including referral information and available community resources. Performs all other duties, as assigned. Minimum Qualification Requirements including education, experience, licensure/certification, etc. and essential physical capabilities (e.g. lifting, assisting lifting, standing, etc.) Valid license and current registration as a Registered Nurse issued by the New York State Education Department (NYSED); and Current Basic Life Support (BLS) certification for Healthcare Providers; and Minimum of three (3) years of clinical experience as a RN performing direct care duties ideally in pediatrics and/or with patients with I/DD (multiple disabilities, brain injury/brain-based disorders, etc.) Exhibits exceptional interpersonal, problem solving, communication skills, along with the ability to take initiative, and a highly flexible personality. Preferred Qualification Requirements (desired requirements beyond MQRs above) Bachelor of Science degree in Nursing (BSN) Previous experience as a supervisor of clinical or nursing staff Knowledge of specialized health needs and treatments for children with severe and multiple disabilities Compensation: $105,000-$110,000 Annually

Hello, we're L'Oréal, We're not just building brands, we're shaping how the world experiences beauty (and it takes a lot of cool jobs to do it). Intrigued? Keep reading, this might be the opportunity you've been searching for. A Day in the Life As the Clinical Research Director for SkinCeuticals, you will be at the forefront of our scientific validation, leading the operational execution of clinical studies. You will collaborate with leading Healthcare Professionals (HCPs) and internal teams to deliver robust scientific evidence for our advanced skincare innovations. Lead Clinical Operations: You will manage the entire lifecycle of 7-10 global clinical projects, from protocol development and contract negotiation to budget and timeline management with CROs and HCPs. Drive Scientific Communication: You will summarize study results into compelling presentations, publications, and abstracts, effectively communicating our scientific advancements to both medical and internal audiences. Act as a Strategic Partner: You will serve as the key liaison between internal stakeholders (Marketing, Global, R&I) and external partners, ensuring study objectives are met with scientific integrity and within deadlines. Innovate & Build Knowledge: You will stay ahead of the curve by researching the testing landscape, presenting innovative study opportunities, and maintaining a global clinical research database to support future product development. We Are Looking For We are seeking a highly experienced clinical research professional with a strong scientific background and a sharp analytical mind. You are a conceptual thinker, adept at building relationships and thriving in a cross-functional environment. You have: * An advanced degree in a clinical or scientific field (e.g., BS, MS, PhD, PharmD). * Significant experience in clinical research, ideally within Medical/Cosmetic Dermatology, Plastic Surgery, or facial aesthetics. * Proven ability to manage projects, including budgets, timelines, and contracts, while overseeing study protocols to ensure data integrity. * Excellent analytical and presentation skills, with the ability to translate complex data into clear, impactful communications. * Strong interpersonal skills to effectively collaborate with and present to internal teams and external Healthcare Professionals. The 5 most relevant skills for this role are: * Clinical Innovation & Evaluation * Skincare Expertise * Scientific Valorization * Medical Relations * Project Management * Stakeholder Management What's In It For You A place for you to leave your comfort zone and grow beyond your potential (here, you'll be encouraged to try new things and take risks!) Real responsibility from day 1, there's no sitting on the sidelines at L'Oréal An environment where people of every ethnicity, social background, age, religion, gender and sexual orientation as well as people with disabilities are accepted, can speak up, will thrive and are celebrated! A place where you can contribute to something bigger! Many of our brands have societal /environmental causes to make concrete difference Who We Are L'Oréal is present in 150 markets on five continents. For more than a century, L'Oréal has devoted itself solely to 'Create beauty that moves the world'; it is now the industry world leader with €42 billion consolidated sales. Together, we solve complex challenges at scale, while making sure we stay committed to making the world a more inclusive and a better place for everyone & our planet. The mission of L'Oréal Dermatological Beauty is to "Pioneer health and beauty to give the world life changing and sustainable dermatological solutions for all." As the #1 medical aesthetic skincare brand worldwide, SkinCeuticals is a leader in medical professional skincare, pushing the limits of science to deliver the most advanced skincare for physicians and consumers. Our products are used, sold, and recommended by top dermatologists, plastic surgeons, and aesthetic professionals to deliver high-potency skincare that can also complement professional treatments. We're committed to guaranteeing inclusive recruitment processes and to advocating for hiring and promoting each candidate in an ethical and equitable way. The Group strictly prohibits discrimination against any applicant for employment because of the individual's gender identity or expression, sexual orientation, visible and/or invisible disabilities, socio-economic and/or multicultural origins, health conditions, age, religion, or any other characteristics protected by law.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job DescriptionMedical Affairs leader for assigned compound(s) and /or project(s under the leadership of a Sr. GBMD or GMA Franchise head. Major Activities: For assigned compound/indications, work collaboratively across functions, within GPT to execute an integrated Medical Affairs plan including clinical trials, publication, medical education and medical information. Manages all operational aspects and drives execution for assigned projects of Global Medical Affairs clinical trials in partnership with global line functions, assigned Clinical Trial Heads (CTHs), and regional/country medical associates. Participates and contributes to the joint ICT s. Provides Medical leadership to CTT s for Client sponsored GMA trials Leads review of investigator-sponsored trials and Local/Regional Medical Affairs trials concept sheets, within MRC, for assigned projects(s). Provides medical support for educational events (e.g. stand-alone meetings, scientific symposia) and scientific congresses within legal and compliance regulations. Collaborates across functions to achieve approval of key scientific communications, medical information documents and commercial documents within NP4 legal and compliance regulations. Skills: Fluent oral and written English. Have expert operational knowledge and experience in clinical trial design and all stages of clinical trial conduct (Trial design, Start-up, Execution, Analysis, Reporting). Have an excellent knowledge of current clinical practice in Oncology / Hematology / Endocrinology or other relevant disease area. Have strong knowledge in and understanding of medical activities (including scientific communications, medical information, MSLs, and HEOR), relating to the commercialization of oncology products. 5 years experience in pharma at local, regional and/or Global level. Provide medical expertise to ensure successful product launches across functions. NVS sponsored trials Review and coordinate IITs Implement patient access programs Review promotional materials & publications Integrate medical expertise with commercial perspective. Maintain an external focus to optimize and maximize treatment options and compound life cycle management. Timely implementation and delivery of high quality Medical affairs clinical programs within budget, in full compliance with Client Standard and GCP/ICH. Well managed and effective clinical teams. External satisfaction, acceptability of clinical data by key decision makers including health authorities, payers. Development of high-quality scientific communications and medical information. Strong alignment between Global and Regional/local medical organizations. Strong alignment within global line functions. More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred. QualificationsEducation: MD Required More than 4 years advanced knowledge in medical/scientific area (Oncology, Hematology, Endocrinology) preferred Additional InformationNeha Sharma Lead Recruiter Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Website: ******************

Job Description At Moxie, we empower ambitious aesthetic entrepreneurs to build profitable, independent practices-without burnout, overwhelm, or guesswork. In just a few years, we've grown from an idea to a global, remote-first team of more than 140 people, supporting hundreds of practices nationwide. Our purpose is simple: to unlock sustainable success for aesthetic entrepreneurs, at every stage of their journey. **Must reside or have a primary office in New York, and hold an active NY license. We work with talented nurse injectors to empower them to build independent businesses. We help connect Medical Directors to RN, NP, and PA providers, to provide insight into state regulations and standards of care. Our providers work through our software platform which streamlines administrative tasks to allow you to focus on medical partnership. Review SOPs, consent forms, charts, etc. Be on call in case of emergency Provide general supervision according to state law Once vetted, you will interview and choose to partner with the injectors of your choice, at the rates you set. You can work with as many injectors as you choose and state law permits. Requirements: MD or DO with an active state license Minimum of 1 year of experience in medical aesthetics and/or medspa settings Minimum of 1 year of experience providing medical oversight, such as serving as a Medical Director or Collaborating/Supervising Physician Formal Training in injectables and other aesthetic services. A resident of the state of New York or New Jersey Benefits: Pay & Perks Competitive compensation Liability is covered Other Info: This is a PC owner position - Moxie manages everything on your behalf for the PC Experience in either Dermatology, Plastic Surgery, Ophthalmology, or Oculoplastic Surgery is a plus We're specifically looking for Medical Directors licensed to practice in NY. At Moxie, we believe in creating a workplace where everyone feels valued, trusted, and included. Our team lives by our values: act as owners, give more than we take, move with speed and care, and simplify and learn every day. We welcome people of all backgrounds, experiences, and perspectives to apply. If you require any accommodations to fully participate in the interview process, please let us know, we're happy to assist.

The Medical Director, Rare Disease is a critical role responsible for shaping the strategic processes and planning for assets in across phases of development within the Rare Disease portfolio. This position manages the unique challenge of establishing an emerging portfolio, incorporating newly acquired assets, which requires significant scientific and strategic agility and a strong ability to balance competing priorities. This position reports directly to the Rare Disease Medical Business Unit (BU) Lead. **** **Key Responsibilities Include:** **Medical Strategy & Narrative** + Provide key medical input into the initial development of the Target Reimbursable Product Profile as well as early development plans ensuring scientific consistency and alignment across functions (e.g., R&D, Clinical, Global Medical Affairs) + Provide high-quality scientific/clinical input and review of early asset plans, ensuring content aligns with the overarching Medical Narrative + Lead and nurture strategic partnerships with stakeholders by ensuring clear, consistent communication and aligning initiatives with partner priorities to strengthen collaboration and drive shared success in the rare disease space + Serve as a primary scientific resource, providing guidance on the disease state and mechanism of action for the Rare Disease portfolio helping to translate science into value for patients and stakeholders + Lead the Strategy and Tactical Planning Process, identifying critical data needs for the emerging portfolio **Evidence Generation Process** + Oversee the Medical Evidence Generation Process in partnership with GIE&I, translating strategic data gaps into clear research priorities and providing expert input into the design and feasibility of innovative clinical trials and data generation initiatives + Support the planning and execution of Medical Affairs evidence generation activities relevant to the Rare Disease portfolio **External Stakeholder Engagement** + Identify and engage a wide variety of stakeholders, including KOL experts and patient advocacy groups to support collection, curation and communication of clinical Medical and methodological insights to inform understanding of unmet medical needs, emerging standard of care and development opportunities + Develop Key Intelligence Topics & Questions (KITs/KIQs) for relevant assets, serving as the blueprint for insight collection from Key Opinion Leaders + Lead the strategic planning, content development, and successful facilitation of consulting activities including Advisory Boards, ensuring objectives align with data gap analyses and asset/portfolio strategy + Lead scientific exchange with key opinion leaders (KOLs) to gather insights and validate development hypotheses + Support the development of scientific publications, abstracts, and presentations related to the Rare Disease portfolio **Cross-functional Integration & Planning** + Collaborate within the Rare Disease Medical Business Unit with the Rare Disease Medical Communications and Field Medical Affairs sub-teams + Partner with and serve as a scientific and clinical resource for cross-functional colleagues including Clinical Development, Global Integrated Evidence & Innovation, Regulatory and Global Marketing and Market Access + Support indication prioritization and portfolio planning for early assets + Manage assigned Rare Disease medical program budgets in partnership with the Rare Disease Medical BU lead, ensuring accurate forecasting, responsible resource utilization, and compliance with internal policies and external regulations + Consider technology and AI to support workflow improvement **Qualifications** **Education and Experience:** + Advanced scientific degree is required (PharmD, MD, PhD, or equivalent) with extensive expertise in Rare Disease + Minimum of 5+ years of relevant experience in the pharmaceutical industry, with strong preference for experience in Clinical Development, Research, or Medical Affairs + Experience supporting BD evaluations for potential acquisitions + Experience contributing to the integration and strategic planning for newly acquired or in-licensed assets + Proven experience managing Evidence Generation processes and executing scientific Advisory Boards **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Skilled in cultivating strong relationships with global medical partners through proactive communication and strategic prioritization + Motivated and solution-oriented with the ability to work collaboratively across the organization, particularly with R&D and Clinical teams + Strategic agility required to build and adapt scientific strategy for an emerging portfolio + Excellent communication and interpersonal skills, including experience presenting complex development strategies to large internal groups and engaging a limited number of highly specialized external experts + Full understanding of rules and regulations in pharma, with the ability to apply knowledge of guidelines and regulations to early-stage Medical Affairs activities + Ability to work in a fast-paced, dynamic environment, with a proactive and problem-solving mindset + Strong understanding of drug development processes, especially early-stage development + Openness to travel up to ~25% for 3 - 6 conferences in US and globally **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 $209,599.00 - Maximum $313,375.00, 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; ********************************************* . **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 ******************************************************* . 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: ************. 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: ******************* , 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.

Medical Director Veterinarian The Pet Doctor - Flushing, NY Ownership/Equity Opportunity Available! The Pet Doctor, a well-established small animal practice in Flushing, New York, is seeking an experienced, confident veterinarian to step into a Medical Director role. This is an excellent opportunity for a veterinarian who enjoys clinical leadership, team development, and practicing high-quality medicine in a diverse, fast-paced community. This position is not suitable for new graduates. We are seeking a veterinarian with several years of clinical experience who is comfortable practicing independently and leading a medical team. Why The Pet Doctor? * Established, community-trusted practice * Supportive, experienced staff * Opportunity to shape the medical direction of the hospital * Competitive compensation commensurate with experience * Leadership role with professional autonomy Why Flushing, NY? Flushing is one of New York City's most vibrant and culturally rich neighborhoods, making it an exciting destination for veterinarians relocating from out of state. Highlights include: * Easy access to Manhattan via public transportation * Minutes from LaGuardia Airport and close to JFK * World-class dining and diverse cuisine * Flushing Meadows-Corona Park, one of NYC's largest green spaces * Urban energy with nearby suburban living options in Queens and Long Island * Arts, culture, sports, and entertainment at your doorstep Flushing offers the perfect balance of career growth, cultural richness, and city convenience, whether you're looking to build a long-term home or enjoy everything NYC has to offer. Ready to Lead? If you are an experienced veterinarian looking for a leadership role in a dynamic, well-established practice, we would love to hear from you. Apply today to join The Pet Doctor in Flushing, NY. Job Description As Medical Director, you will: * Provide high-quality medical and surgical care to a loyal client base * Lead and support the veterinary team with confidence and professionalism * Establish and uphold medical standards and protocols * Collaborate with management on hospital operations and growth * Serve as a clinical mentor to support staff and promote a positive workplace culture What We're Looking For * DVM or VMD degree from an accredited veterinary school * Several years of clinical experience in small animal medicine (required) * Strong diagnostic, surgical, and communication skills * Leadership experience or interest in a Medical Director role * Licensed (or eligible for licensure) in New York State Qualifications * Doctor of Veterinary Medicine (DVM) degree or equivalent from an accredited university * Active Veterinary State License (or ability to obtain upon hire) * Current DEA License (or ability to obtain upon hire) * USDA Accreditation (or ability to obtain upon hire) Additional Information WE ARE A DRUG-FREE, SMOKE-FREE, EQUAL OPPORTUNITY EMPLOYER. Company Policy & Federal & State Laws Forbid Discrimination Because of Age, Color, Race, Religion, Sex, Disability, Sexual Orientation or National Origin Pay is customizable and based on experience and/or potential for bonuses. A general range for a base salary is $130,000 - $190,000 DOE and compensation package. #IND3

Who we are: Woodbridge Veterinary Group, located just 30 minutes from the Jersey Shore, is seeking a passionate and experienced veterinarian to step into a Chief of Staff role at our multi-doctor practice. This is a rare opportunity to blend your clinical expertise with leadership, helping to guide a supportive, collaborative team that's committed to exceptional patient care and strong community ties. Why Woodbridge Veterinary Group? State-of-the-Art Facility Equipped with advanced ultrasound, digital radiography, modern dental suites, and in-house lab capabilities to support a full spectrum of diagnostics and treatment. Surgical Focus Perfect for a veterinarian who loves surgery and wants to grow in a hands-on, fast-paced environment. Community-Rooted We proudly support the local Woodbridge Animal Shelter and are committed to animal welfare in our town. Balanced Work Life No emergency or on-call shifts-allowing for a healthy work-life balance and time to recharge. Leadership Role Highlights As Chief of Staff, you'll take an active role in shaping hospital culture, guiding medical quality, mentoring veterinarians and staff, and partnering with practice management to drive both short- and long-term success. Your leadership will inspire growth, innovation, and collaboration throughout the hospital. Who You Are A seasoned veterinarian with strong surgical interest and clinical confidence Excited about stepping into a leadership position or growing into one A compassionate communicator who thrives in a team-oriented, patient-first setting Passionate about community engagement and client relationships What's in it for you: Benefits include superior salary, medical benefits (including health, dental and vision), 401(k), employee assistance program (EAP), CE allowance, vacation, dues, liability coverage, and so much more. Job Title: Chief of Staff Location: Woodbridge Veterinary Group Salary Range: $175,000 - $200,000 (Straight Salary or Production Salary available) SIGNING BONUS! Our practice has a positive, well-being focused culture that we'd love to tell you about. Where we are: Known as the "Heart of New Jersey," Woodbridge is an excellent place to live for a new graduate or experienced veterinarian alike. Residents have access to world-class healthcare facilities and a short commute to New York and Philadelphia.

360 IT Professionals is a Software Development Company based in Fremont, California that offers complete technology services in Mobile development, Web development, Cloud computing and IT staffing. Merging Information Technology skills in all its services and operations, the company caters to its globally positioned clients by providing dynamic feasible IT solutions. 360 IT Professionals work along with its clients to deliver high-performance results, based exclusively on the one of a kind requirement. Our services are vast and we produce software and web products. We specialize in Mobile development, i.e. iPhone and Android apps. We use Objective C and Swift programming languages to create native applications for iPhone, whereas we use Android Code to develop native applications for Android devices. To create applications that work on cross-platforms, we use a number of frameworks such as Titanium, PhoneGap and JQuery mobile. Furthermore, we build web products and offer services such as web designing, layouts, responsive designing, graphic designing, web application development using frameworks based on model view controller architecture and content management system. Our services also extend to the domain of Cloud Computing, where we provide Salesforce CRM to effectively manage one's business and ease out all the operations by giving an easy platform. Apart from this, we also provide IT Staffing services that can help your organization to a great extent as you can hire highly skilled personnel's through us. We make sure that we deliver performance driven products that are optimally developed as per your organization's needs. Take a shot at us for your IT requirements and experience a radical change. Job Description Accountable for deliverables of the Global Medical Affairs function, including expert review and evaluation of Benefits and Risk for RX to OTC switch products. Deliver Medical rationale, benefit/efficacy, core science summaries in support of Regulatory Submissions. Engage with external medical and scientific leaders in support of medical strategy. Skills: 1. Critical thinking in order to support application of scientific literature to solve 2. Ability to work on complex projects with highly-matrixed teams 3. Facilitate debate and conclusions to drive high quality, innovative project deliverables Additional Information Thanks and Regards, Isha Sharma 408-766-0000- EXT 425 isha.sharma@)usitsol.com

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. Summary The Associate Director, Medical Information Oncology, is responsible for leading and driving Global & US Medical Information activities for assigned therapeutic area(s) to meet the Eisai product information needs of external customers and internal business partners. This role is seen and sought after for their subject matter expertise in Oncology and assigned therapeutic area(s) and serves as medical reviewer of Eisai's advertising, promotional, and scientific exchange materials as part of Copy Review Committee and Medical Review Committee. Beyond traditional responsibilities, this position offers a unique opportunity to optimize and communicate medical information insights as part of a broad, cross-functional strategic team, ensuring these insights inform decision-making and drive innovation across the organization. The Associate Director will also leverage and implement AI-driven tools and capabilities in new and transformative ways, enhancing efficiency, personalization, and scalability of medical information services. The AD, Medical Information contributes to the development and implementation of medical plans, including the creation of standard medical responses, development of AMCP dossiers, compendia submissions, and other medical information deliverables. This role is also responsible for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to performance improvement activities, conducting quality monitoring, tracking and reporting of medical information insights and metrics, ensuring regulatory compliance, inspection readiness, and appropriate documentation and reporting of product incident reports. Responsibilities · Develop and manage tactical execution of the Medical Information component of Global & US Medical Affairs strategic plans for assigned therapeutic area(s). · Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; conduct quality assurance measures and handle escalated inquiries as needed. · Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, AMCP dossiers, compendium and pathways submissions, etc. · Serve as medical reviewer, ensuring medical accuracy and provision of feedback for Eisai's advertising, promotional, and medical materials as part of Copy Review Committee and Medical Review Committee. · Lead and provide oversight of department reporting processes, KPIs, insights analytics, digital analytics, and other trend reports that are shared with internal stakeholders; proactively identify opportunities to optimize insights for strategic decision-making. · Explore and implement AI-driven tools and technologies to enhance medical information processes, improve efficiency, and deliver innovative solutions for internal and external stakeholders. · Liaise with global and regional medical affairs colleagues as appropriate. · Provide strong scientific support for conference and booth coverage. · Implement and participate in department training, process and performance improvement activities, quality monitoring, metrics tracking, regulatory compliance, inspection readiness, and product incident response. · Serve as a business partner to internal and external collaborators as needed to support scientific exchange activities and address critical escalations as warranted. · Provide mentoring, guidance, and training to new hires/less experienced colleagues. · May provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate. Qualifications: · Advanced degree in sciences or related field with 10+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience. · Strong scientific knowledge and expertise in Oncology, including evaluating and communicating clinical trial and disease state information to a wide range of audiences. · Demonstrated experience in conducting scientific literature review, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, dossier, compendium submissions, etc.) · Practical experience and knowledge of FDA guidances on appropriate scientific exchange practices. · Previous experience of managing/leading teams directly/indirectly or coaching and mentoring new hires/less experienced colleagues. · Proficiency with Microsoft Office Suite software, SharePoint, Veeva, customer relationship management software, and other technology and telephony systems. Additional Preferred Qualifications: · Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights. · Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions. · Strong understanding of data visualization and insights reporting to support strategic decision-making. · Able to travel as needed (approximately 10% on average). · This role is hybrid in Nutley, NJ (in office every week on Tuesday, Wednesday, and Thursday) Skills:Communication & Cross-functional Influence, Critical Thinking & Business Agility, Healthcare Environment Dynamics, Inquiry Resolution, Literature Evaluation, Medical Information Writing Skills, Medical Review, Mentoring/ People Development, Resource Planning & Management Eisai Salary Transparency Language: The annual base salary range for the Associate Director, Medical Information, Oncology is from :$162,600-$213,400Under current guidelines, this position is eligible to participate in : Eisai Inc. Annual Incentive Plan & Eisai Inc. Long Term 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 ********************************************************** 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

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance as part of the Clinical Development Team working in Somerset, NJ. Role Overview The Sr. Medical Director, Drug Safety & Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Key Responsibilities Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings. Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects. Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)) Identification and management of Urgent Safety Measures with support of cross functional team. Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight. Oversee and manage internal safety scientist and safety operation team. Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals. Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.) Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed. Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership. Prepare/oversee monthly progress reports and ad-hoc reports as required Support process improvement and functional training at departmental & company level Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations Requirements MD or MBBS or MD-PhD or equivalent medical degree 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. Strong understanding of pharmacovigilance regulations in the US and EU. Experience in supporting drug safety activities in registrational clinical studies High level of medical competence, with an ability to balance this with industry standards to achieve business goals Demonstrated skills in scientific analysis and reasoning. Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable Strong track record of delivering results through effective team and peer leadership in matrix Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.) Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. Experience in biotech - preferred but not required. #Li-LB1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is:$285,906-$375,253 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

EmTacq specializes in EM ployer T alent ACQ uisitions, matching the most qualified candidates with the most competitive positions available. We pride ourselves on not just putting bodies in seats, rather matching professionals to their careers. We are headquartered in the Raleigh / Durham, NC area. However, as a recruiting agency we service companies and candidates across the United States. We are your best source for professional, value driven low cost recruitment services. Our primary focus is providing a one-on-one recruiter relationship and provide top Direct hire performers to our clients. Our goal is to make each hiring experience simple and successful. We want to be your “Employment Partner" and are excited to assist you with all your employment needs. We look forward to building and maintaining a solid relationship. Our MISSION STATEMENT is to provide "Personnel Services with a Personal Touch". Our philosophy is to employ only the best, skilled candidates to create the perfect "fit" for each client. We follow that up with unsurpassed customer service. Job Description This medical writing expert role will assume overall responsibility for directing the development and implementation of the medical communication strategy for all regulatory submission documents for all assigned drug projects and work with assigned Senior Medical Writers and Submission team experts in developing and implementing the submission authoring strategy for all clinical sections. Qualifications An advanced Degree in Science 8+ years of experience in the pharmaceutical industry 6+ years of experience in regulatory medical writing involving all clinical document types in more than one therapeutic area. Must have experience in electronic document management and electronic regulatory submissions, tools and standards. Strong leadership experience and the ability to mentor Excellent verbal and written communication skills Some travel may be required. Additional Information Must be a US citizen or Green Card holder. All your information will be kept confidential according to EEO guidelines.

The Director, CNS Publications Lead is responsible for leading the planning, development, and execution of the global medical publication strategy and publication deliverables for the CNS therapeutic area. This role ensures the timely, accurate, and compliant communication of scientific and clinical data through congress abstracts, posters, manuscripts, and other peer-reviewed outputs. Serving as the functional lead for publication operations within the CNS Medical Communications team, the Director partners closely with cross-functional stakeholders, including Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Medical Strategy, Core Content, and external vendors, ensuring excellence and consistency in scientific communication across the portfolio. The position reports to the Senior Director, CNS Medical Communications Lead and plays a key leadership role in advancing Otsuka's mission to deliver impactful, evidence-based science that improves patient outcomes. **** **Key Responsibilities Include:** **Publications Strategy and Execution** + Lead execution of the publication plans for CNS assets, ensuring strategic alignment with global medical and communication objectives, data dissemination priorities, and the product lifecycle + Partner with Medical Communications and cross-functional teams to define publication timelines, data priorities, and congress/journal strategies in collaboration with study teams and medical leaders + Oversee the end-to-end development of publication deliverables, including abstracts, posters, and manuscripts to ensure scientific accuracy, quality, and adherence to Good Publication Practices (GPP), ICMJE, and company SOPs + Support the integration of publication insights into broader scientific communication platforms (SCPs), ensuring consistency across core content, field materials, and other medical channels + Future potential to manage other direct reports or a team **Vendor & Budget Management** + Manage publication vendors and medical writing partners to ensure timely delivery, cost-effectiveness + Oversee operational management of external publication agencies, providing clear direction, review, and feedback to ensure alignment with scientific and compliance standards + Manage assigned publication budgets, including forecasting, tracking, and reconciliation + Ensure efficient resource utilization and drive continuous process improvement across publication workflows, including considering managing in-house development of some publication content **Cross-functional Leadership** + Collaborate closely with Clinical Development, Global Integrated Evidence & Innovation, Medical Strategy, and Core Content teams to ensure data readiness, accurate interpretation, and timely publication of key clinical results + Serve as a publications subject matter expert within the CNS Medical Communications function, providing strategic and operational guidance and support to internal stakeholders and vendors + Partner with Field Medical and Medical Core content leads to ensure consistency of published data messaging across medical channels and external communications + Contribute to integrated medical communication planning, ensuring that publications effectively support data dissemination goals and launch readiness activities + Consider technology and AI to support workflow improvement **Compliance & Quality Oversight** + Ensure all publication activities are conducted in accordance with internal SOPs, GPP, ICMJE, and regional/global regulatory requirements + Partner with Legal, Regulatory, and Compliance teams to uphold publication governance, authorship transparency, and ethical data sharing standards + Contribute to audit readiness and documentation best practices for publication records and approvals **Qualifications** **Education and Experience:** + Advanced scientific or medical degree (PharmD, PhD, MD, or equivalent) required + 10+ years of experience in Medical Affairs, Medical Communications, or Publications within the pharmaceutical or biotechnology industry + Minimum 3-5 years of experience leading publication planning and execution for global or regional programs, preferably in CNS or related therapeutic areas + Proven experience managing vendors and external medical writers, including budget oversight and performance evaluation + Strong understanding of Good Publication Practices (GPP), ICMJE guidelines, and industry standards for scientific and medical communication **Skills and Competencies:** + Strong leadership presence and ability to present to executive leadership team + Demonstrated ability to lead publication strategy execution across global and regional teams + Exceptional project management and organizational skills, with the ability to manage multiple concurrent publication deliverables + Excellent written and verbal communication skills, with meticulous attention to scientific accuracy and compliance + Strong cross-functional collaboration skills, with the ability to influence and align internal and external partners + Proven leadership in vendor management, process optimization, and publication operations + Financial acumen and experience managing publication budgets + Strategic thinker with operational excellence mindset and the ability to translate complex data into clear, evidence-based scientific narratives + Proven experience leading a team a plus **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 $186,489.00 - Maximum $278,875.00, 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; ********************************************* . **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 ******************************************************* . 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: ************. 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: ******************* , 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.

Who we are: Raritan Animal Hospital is seeking a dedicated and visionary Chief of Staff to lead our medical team and ensure the continued delivery of high-quality veterinary care. We are a thriving, community-centered practice consisting of a full-service main hospital supported by three outpatient clinics. This structure allows us to offer convenient access and continuity of care while maintaining the highest medical standards. We work closely with board-certified internal medicine, surgery, and cardiology specialists to provide advanced diagnostics and treatment options for our patients. Our facilities include: A well-equipped main hospital with modern amenities including an in-house labs, digital radiography, complete dental suite with dental radiography, newly renovated surgery suite with comprehensive monitoring systems and radiowave surgery A skilled, well-trained team of technicians who provide outstanding support to our doctors Beyond medicine, we're proud of our fun, inclusive, and community-focused culture. Our team enjoys events like Halloween costume contests, pictures with Santa, in-clinic egg hunts, and regular in-house CE opportunities that support ongoing learning and collaboration. What We're Looking For: Provide visionary oversight of all clinical care, ensuring outstanding patient outcomes and adherence to gold-standard medical practices. Champion new technologies and medical advancements to continually elevate our standard of care. Inspire and mentor associate and new graduate veterinarians through case collaboration and professional development. Foster a supportive and communicative team culture grounded in respect, collaboration, and growth. Cultivate strong client relationships with visibility, approachability, and excellent communication skills. Support initiatives that enhance client satisfaction, loyalty, and the hospital's well-earned reputation for compassionate care. What's in it for you: Vetcor offers a comprehensive benefits package that supports your well-being and professional growth. Enjoy medical, dental, and vision insurance, a 401(k) with company match, generous paid time off, CE allowance, paid parental leave, and access to a vast network of veterinary professionals. We also offer mental health support, employee discounts, and a culture that truly values work-life balance. Ready to connect? Email Kaley at *****************! Job Title: Chief of Staff Location: Raritan Animal Hospital Salary Range: $175,000 - $200,000 + Production Bonus (No Negative Accrual!) Our practice has a positive, well-being focused culture that we'd love to tell you about. Where we are: Edison, New Jersey is a vibrant, diverse township located in central New Jersey, just 30 miles from New York City. Known for its rich history-it's the home of Thomas Edison's famous Menlo Park lab-Edison offers a blend of suburban comfort, excellent schools, and easy access to major highways and public transit. With bustling shopping centers, parks, and a strong sense of community, it's a great place to live, work, and explore.

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Sr. Medical Director, Drug Safety & Pharmacovigilance as part of the Clinical Development Team working in Somerset, NJ. Role Overview The Sr. Medical Director, Drug Safety & Pharmacovigilance is a critical role in the company with significant impact on the development and life cycle of drug development projects. Responsible for providing safety strategy, expertise and guidance to the clinical development and project team for the assigned products. The Sr. Medical Director will drive the proactive implementation of risk management initiatives in accordance with global regulatory requirements. Core responsibilities will encompass continuous and efficient evaluation of safety data, perform signal detection, evaluation and assessment and management of the safety profile of the compound. In addition, the position will ensure program consistency & alignment across studies, working closely with cross functional teams for achieving project goals, within timelines & with high quality. Key Responsibilities * Lead and support development of pharmacovigilance strategy and activities to ensure compliance with corporate clinical development and commercial goals. * Conducting signal detection activities, include monitoring, evaluation, interpretation, management and communication of safety information. * Responsible to conduct Safety Monitoring Team (SMT) meeting(s) to evaluate risk-benefit for the compounds with support from cross functional teams. Escalate and present unresolved safety issues to senior management in company governance meetings. * Medical safety review including causality assessment of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing and literature) throughout the development process for assigned compounds/projects. * Provides medical expert safety review input into all critical documents for products in clinical development (e.g., INDs/NDA/BLA submissions, protocols and amendments, ICFs, IBs, and clinical research reports (CSR)) * Identification and management of Urgent Safety Measures with support of cross functional team. * Overview, and/or author aggregate reports and signal evaluation reports for assigned projects. * Responsible for the Clinical content of responses to inquiries from regulatory authorities related to Safety topics. * Provide leadership and support to Contract Research Organization (CRO) staff to ensure overall delivery of services. Ensures vendor oversight. * Oversee and manage internal safety scientist and safety operation team. * Assist with the writing and development of SOPs as required to ensure compliance to regulations and local laws, while maintaining clear instructions for procedures and activities to the achievement of company goals. * Lead the development of a significant drug safety budget and effectively manage resources, funding and expenses * Lead high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, SSC, Regulatory Authority meetings, etc.) * Demonstrated ability to build effective working relationships, influence, negotiate, and drive organizational engagement. Ability to be flexible and adapt quickly to the changing needs of the organization. Work closely with a key strategic alliance partner for projects that are being jointly developed. * Identify project risks with input from the cross functional teams, and support resolving issues. Ensure that any potential delays are fully mitigated to avoid any delays with full transparency to senior leadership. * Prepare/oversee monthly progress reports and ad-hoc reports as required * Support process improvement and functional training at departmental & company level * Assure that the highest quality, ethical & professional values are demonstrated in all aspects of the teamwork * Ensures compliance with corporate policies and procedures, as well as all related healthcare laws and regulations Requirements * MD or MBBS or MD-PhD or equivalent medical degree * 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance. * Strong understanding of pharmacovigilance regulations in the US and EU. * Experience in supporting drug safety activities in registrational clinical studies * High level of medical competence, with an ability to balance this with industry standards to achieve business goals * Demonstrated skills in scientific analysis and reasoning. * Sound knowledge of overall drug development process from discovery to registration and post marketing requirements & surveillance. * Prior IND, as well as NDA/BLA (filing/submission) and other regulatory interaction experience is highly desirable * Strong track record of delivering results through effective team and peer leadership in matrix * Experience as a manager, plan and manage daily activities of team; coaches/mentors/trains team; leads performance management activity (goal setting, performance appraisals, etc.) * Excellent leadership & organizational skills, analytical skills, presentation skills, and strong experience in translating important data into clinical strategies. * Experience in biotech - preferred but not required. #Li-LB1 #Li-Hybrid The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. Performance-based bonus and/or equity is available to employees in eligible roles. The anticipated base pay range is: $285,906-$375,253 USD Benefits Benefits include medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work. Please note: These benefits are offered exclusively to permanent full-time employees. Contract employees are not eligible for benefits through Legend Biotech. EEO Statement It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend may adjust base salary or other discretionary compensation at any time based on individual, team, performance, or market conditions. For information related to our privacy policy, please review: Legend Biotech Privacy Policy.

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Responsible for the management of the Medical Safety Evaluation Office (MSE) and lead all medical aspects of safety assessments and safety management of assigned global products throughout the product lifecycle (development and marketed). Will lead and chair global safety teams in the assessment of safety data, signal management, risk management collaborating with international affiliates and MTPC corporate. Will lead projects and process improvement to support the global safety function within GDSEC and MTPG. Job Description Responsible for the management of the Medical Safety Evaluation Office (MSE) of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Implements relevant policies to ensure the safety of the product in global development and post-marketing portfolio. Accountable for providing medical input to the assessment of the safety profile for each drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for activities including but not limited to, development of aggregate reports, signal detection process, ad hoc report preparation, and providing recommendations to Global Safety Committee (GSC) on necessary actions to protect patient safety Provides oversight of medical safety evaluation for assigned global investigational products Coordinates and contributes to medical assessment for assigned global post-marketing products Implements and maintains an optimized system for signal detection, risk-benefit management, and safety medical evaluation. Partner with relevant internal and/or external experts to fulfill responsibilities Provide medical advice, training, and support to the Pharmacovigilance team and other functions contributing to medical evaluation, signal detection, and risk-benefit assessment activities. Provides primary liaison between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, and CROs) on product safety related issues as assigned. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing Oversees data collection, processing, assessment, and preparation of annual reports, and periodic reports to ensure the timely submission to international regulatory agencies Responsible for review and finalization of medical assessments of safety data [Periodic/Development Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents, as appropriate) Responsible for medical review of medically coded safety data, including adverse events, medical history and concomitant medications Responsible for review of documents such as periodic safety update reports and benefit-risk evaluation Responsible for the oversight of safety aspects of the planning, execution, data collection and interpretation of clinical research data Provides input to senior management, as requested, regarding safety aspects of product development strategy, key messages, data review, and future data needs Oversees development and preparation of Risk Management Actions Plans for regulatory filings Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements Works with medical affairs team to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities Accountable for the performance and results of the Medical Safety Evaluation Office within Drug Safety department. Qualifications Education: Medical Degree (MD or DO), and current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience Professional Experience: Minimum of 10 years pharmaceutical experience in US and international Drug Safety, Medical Affairs, and/or Clinical Development functions Minimum of 5 years' management experience leading a drug safety group in the pharmaceutical industry Extensive experience writing pharmaceutical regulatory or clinical research safety documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Ability to travel domestically & internationally as required, typically up to 30% Knowledge and Skills: Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Thorough knowledge of US and International Safety reporting regulations and guidelines (in particular ICH clinical safety guidelines) Experience in Phase II/III trials, especially with key safety activities Experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Demonstrated authorship of PSUR, REMS or RMP, and DSUR Experience in supervising drug safety personnel, budgeting, organizing and planning for a growing drug safety department supporting multiple products and global expansion Experience with ARISg or other safety database programs Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:

EmTacq specializes in EM ployer T alent ACQ uisitions, matching the most qualified candidates with the most competitive positions available. We pride ourselves on not just putting bodies in seats, rather matching professionals to their careers. We are headquartered in the Raleigh / Durham, NC area. However, as a recruiting agency we service companies and candidates across the United States. We are your best source for professional, value driven low cost recruitment services. Our primary focus is providing a one-on-one recruiter relationship and provide top Direct hire performers to our clients. Our goal is to make each hiring experience simple and successful. We want to be your “Employment Partner" and are excited to assist you with all your employment needs. We look forward to building and maintaining a solid relationship. Our MISSION STATEMENT is to provide "Personnel Services with a Personal Touch". Our philosophy is to employ only the best, skilled candidates to create the perfect "fit" for each client. We follow that up with unsurpassed customer service. Job Description This medical writing expert role will assume overall responsibility for directing the development and implementation of the medical communication strategy for all regulatory submission documents for all assigned drug projects and work with assigned Senior Medical Writers and Submission team experts in developing and implementing the submission authoring strategy for all clinical sections. Qualifications An advanced Degree in Science 8+ years of experience in the pharmaceutical industry 6+ years of experience in regulatory medical writing involving all clinical document types in more than one therapeutic area. Must have experience in electronic document management and electronic regulatory submissions, tools and standards. Strong leadership experience and the ability to mentor Excellent verbal and written communication skills Some travel may be required. Additional Information Must be a US citizen or Green Card holder. All your information will be kept confidential according to EEO guidelines.