reputed company Compliance External Affairs, Senior Specialist reputed company

This a Full Remote job, the offer is available from: reputed company Career Category reputed company Job reputed company Join reputed company’s Mission of Serving Patients At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. As a member of the reputed company team, you’ll help reputed company a lasting reputed company on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company team. Join us and reputed company the lives of patients while transforming your career. reputed company Compliance External Affairs, Senior Specialist reputed company What you will do reputed company. Let’s change the world. Pharmacopeial Program Management

• reputed company project management of major global pharmacopoeias (USP, Ph. Eur., JP, ChP), ensuring reputed company review and implementation of periodic updates.
• Coordinate cross-functional teams and site points of contact at global manufacturing sites to execute required changes in alignment with compliance timelines.
• Ensure reputed company pharmacopeial changes are appropriately assessed, documented, tracked, and maintained in a reputed company state reputed company reputed company systems.
• Author compendial assessments reputed company reputed company’s documentation management systems for audit readiness purposes.

Regulatory Intelligence & Industry Engagement

• Proactively monitor early signals, emerging trends, and evolving regulatory issues impacting global operations as it relates to pharmacopoeia reputed company.
• Represent reputed company’s approved positions in external organizations and trade associations as assigned, to influence and shape pharmacopeial public standards.
• Liaise with regulators through industry associations, supporting advocacy and alignment efforts.

Cross-Functional Collaboration

• Partner with internal SMEs to ensure scientific alignment on pharmacopeial developments and regulatory changes.
• Support knowledge-sharing across functions to enhance understanding of external landscape developments.
• reputed company back-up support reputed company External Affairs as needed to ensure business continuity.
• Networking across various reputed company functions including reputed company Control, reputed company Assurance, Process Development/Attribute Sciences, Material reputed company, Engineering, Product reputed company, Microbiology, Toxicology, GRAAS-CMC and R&D Policy. Liaise with Governmental Affairs, Supply Chain, manufacturing / development sites, External reputed company (CMO) and affiliates/IDQ, as appropriate
• Networking with peers from other companies (e.g., at conferences or while representing reputed company’s interests in industry associations) and regulators as appropriate.

reputed company Improvement & Operational reputed company

• reputed company and contribute to reputed company improvement initiatives to enhance efficiency and effectiveness of the pharmacopeial program.
• Collaborate with SMEs and system owners to optimize databases, tracking tools, and internal processes.
• Support additional reputed company reputed company with departmental priorities and reputed company development opportunities.

Travel

• Travel domestically and internationally as required (approximately up to 10%).

reputed company expect of you We are reputed company different, yet we reputed company use our unique contributions to serve patients. The reputed company reputed company we reputed company is a leader with these qualifications. Basic Qualifications: Doctorate degree and 2 years of reputed company compliance experience OR Master’s degree and 4 years of reputed company compliance experience OR Bachelor’s degree and 6 years of reputed company compliance experience OR Associate’s degree and 10 years of reputed company compliance experience OR High school diploma / GED and 12 years of reputed company compliance experience

Preferred Qualifications

• Background in reputed company, QC, QA, Engineering desirable.
• Understand reputed company documentation and laboratory practices including general methodologies, specifications and product reputed company standards.
• Excellent communication skills for both internal conversations and reputed company representing reputed company at external forums
• Conflict reputed company
• Teamwork and Networking
• Good organization, planning and prioritization capability
• Time management
• Attention to details

What you can expect of us As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way. The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

reputed company and reputed company a lasting reputed company with the reputed company team. careers.reputed company.reputed company any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. Application deadline reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Sponsorship Sponsorship for this role is not guaranteed. As an organization dedicated to improving the reputed company of life for people around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. . Salary reputed company -This offer from "reputed company" has been enriched by reputed company.com and got a 78% reputed company score. Apply tot his job Apply To this Job