Technology Compliance Senior Advisor
Location
Indiana + 4 moreAll locations: Indiana | Georgia | Ohio | Virginia | Florida
Posted
36 days ago
Salary
0
Seniority
Senior
No structured requirement data.
Job Description
Technology Compliance Senior Advisor
Elevance Health
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Senior Medical Editor
Syneos HealthHeadquartered in Morrisville, North Carolina, with over 100 U.S. and international offices, Syneos Health provides fully integrated, end-to-end clinical and commercial solutions. A
Sr. Medical Editor (Regulatory Documents + QC) - US Home based Location: Morrisville, NC, United States Job ID: 25108029-OTHLOC-1500-2DOK-2DR Job Description: Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: Why Syneos Health - We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. - We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life. - We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities - Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. - Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. - Perform QC review of documents (eg, clinical study protocols and amendments, clinical study reports [CSRs], Investigator's Brochures, and Module 2 clinical summary documents). - Verify data in documents against the source tables, figures, and listings and format tables. - Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. - Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. - Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. - Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. - Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. - Performs quality review of assigned documents to ensure accuracy. - Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. - Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. - May compile medical writing deliverables. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Improves and ensures the quality of compliance of written deliverables through copyediting, quality review, and document management. Provides advanced editorial guidance and technical expertise in the writing, production, and/or review of regulatory and other scientific/clinical documents. Independently performs advanced quality review or compilation tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Leads editorial team for large deliverables requiring multiple editors. Interacts with medical writing leadership and staff regarding assigned deliverables as appropriate. Provides training and mentoring to other medical editing staff members.
• Use expertise of global quality standards to lead preparedness for regulatory inspections • Collaborate with AbbVie Manufacturing Site leadership and global functional groups • Drive the development and maintenance of a quality culture in the company • Conduct mock audits and prepare global sites for future inspections • Provide consultation, guidance, and strategic input to leadership teams • Ensure the delivery of all quality elements needed for new product launches
Contracts and Compliance Manager
Rainforest TrustRainforest Trust, established in 1988 and headquartered in Warrenton, Virginia, is a nonprofit organization dedicated to purchasing and protecting threatened tr
Contracts and Compliance Manager Location: Remote (USA) Salary: $75,000 - $83,000 Status: Full-time, salaried, exempt Reports to: Director of Operations ABOUT US: Since 1988, Rainforest Trust has been safeguarding imperiled tropical habitats and saving endangered species by creating and expanding protected and conserved areas. That very much includes supporting rights-based conservation measures such as affirming and securing rights to Indigenous or Traditional Territories, recognizing Conserved Areas (OECMs), and establishing traditional Protected Areas, including those with co-management of Indigenous or local communities. Working in partnership with local organizations and communities, we have protected more than 60 million acres of vital habitat across Latin America, Africa, Asia and the Pacific. Rainforest Trust is a 501(c)(3) nonprofit organization that relies upon the generous support of the public to successfully implement our important conservation action. HOW YOU'LL CONTRIBUTE TO OUR MISSION: - Mitigate organizational risk and maximize programmatic and operational efficiency by codifying and managing the end-to-end contracting lifecycle for outgoing grants, consultants, and vendors. - Maintain a centralized library of contract templates that are legally compliant, reflect donor flow-down requirements, and balance standardization for risk-mitigation with the flexibility needed for diverse global working contexts. - Lead the donor intent reconciliation process for modified or cancelled projects, ensuring funds are reallocated in accordance with donor agreements and ethical standards. - Streamline the review and execution of incoming grant agreements by establishing review standards, supporting negotiations, and ensuring obligations are communicated to internal stakeholders. - Ensure organization-wide adherence to applicable regulations through ongoing tracking and development/updates to Rainforest Trust policies and procedures. - Proactively identify, monitor, and mitigate institutional and operational risks by maintaining a comprehensive risk register, ensuring a robust insurance portfolio, and developing policies and SOPs designed to reduce the probability and impact of adverse events. - Serve as the internal advisor on data privacy and information security, ensuring ethical and legal handling of donor and employee information. - Standardize and lead a comprehensive, cross-departmental due diligence framework for all new partners and grantees, ensuring that technical expertise, financial health, and organizational capacity are vetted through a unified process. - Manage and optimize the organization's compliance software stack (e.g. conflict of interest and due diligence tools) to ensure high data integrity and user adoption. - Standardize and support the organization's procurement process, ensuring tools, templates, and guidance are provided to staff for consistent policy adherence. TO SUCCEED IN THIS ROLE, WE'RE HOPING YOU'LL HAVE: - Demonstrated experience managing the full contract lifecycle in an organization with international partners and focused on either conservation, regranting, or other related field, along with strong organization and project management skills - Proven ability to efficiently shepherd diverse internal and external stakeholders through a unified contracting process, supported by a proficiency in building and maintaining digital, stage-based workflows and transparent audit trails - Proven expertise in leading unified due diligence processes, underpinned by a deep technical understanding of OFAC, global sanctions, anti-money laundering, and anti-corruption requirements - Proven ability to lead unified due diligence processes by defining cross-departmental roles, scaling the depth of review based on partnership risk/scale, and synthesizing disparate vetting components into a holistic organizational recommendation that builds consensus among stakeholders with conflicting risk appetites. - Expertise in creating contract templates that are tailored to an organization's working context, retain legal rigor, and are maintained in accordance with evolving regulations, along with a deep understanding of the legal boundaries of restricted funding - Proven experience identifying and resolving high-risk or non-standard terms within donor agreements and negotiating with large institutional donors, and demonstrated ability to lead the internal contract review process by engaging diverse stakeholders and translating complex legal/financial requirements into actionable guidance and internal standards for managing post-execution obligations - Proven ability to proactively track regulatory changes and translate those requirements into actionable, user-friendly SOPs and policy implementation to ensure long-term adherence and organizational alignment - Expertise in quantifying, scoring, and tracking institutional risks through a formal risk register risk management framework, with a demonstrated ability to communicate complex risk profiles to leadership to drive organizational change and proactive mitigation - Familiarity with managing insurance renewals and experience translating business operations to organizational risk to insurance policy - Proven experience interpreting and operationalizing data privacy frameworks and best practices to advise internal teams on the ethical collection, storage, and sharing of sensitive information while maintaining organizational efficiency - Proven experience in the administration and optimization of technology systems or databases designed for compliance; includes demonstrated ability to lead the end-to-end rollout of new digital processes, maintain high data integrity, and drive long-term staff adoption through targeted training and change management - Proven experience designing and standardizing procurement workflows, including the creation of user-friendly templates (RFPs, bid tabs, selection memos) and guidance materials that translate complex policies into actionable steps - Demonstrated commitment and enthusiasm for Rainforest Trust's mission and respect for our core values: Partner for Impact; Respect & Empower People; Act with Integrity & Transparency; Lead with Data; Invest Efficiently. EQUAL OPPORTUNITY EMPLOYER Rainforest Trust values the diversity of our planet and environment and wants our team to reflect the richness of the global population we serve. We believe that striving to maintain a demographically diverse workforce where employees are treated equitably and feel a strong sense of inclusion is not only an ethical imperative but also a key driver of innovation and excellence, enhancing our ability to fulfill our mission of conserving and protecting our natural environment. We put this belief into action by striving to apply this lens to every aspect of employment, from how we hire and recruit, to how we determine compensation and benefits, to the training and development we offer, and the working conditions we create. If you think you have what it takes, but don't necessarily meet every single qualification, please still get in touch. We'd love to have a chat and see if you could be a great fit! We are an equal-opportunity employer and give all qualified applicants consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances. WORKING CONDITIONS AND TRAVEL REQUIREMENTS Rainforest Trust is a remote first organization and the incumbent will be expected to work primarily from home with an excellent internet connection, though part-time office space may be available in Washington DC. Occasional national and/or international travel may be required for organizational meetings and other events. PHYSICAL REQUIREMENTS The physical requirements described here are representative of those that must be met by a teammate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Ability to remain in a stationary position at a computer terminal for an extended period. The person in this position frequently communicates with colleagues both verbally and in writing and must be able to exchange accurate, neat and thorough information. ANTICIPATED SALARY The salary range for this position is $75,000 - $83,000 commensurate with experience. This base compensation range represents the anticipated low and high range of wages for this position. Salaries will vary and will be based on various factors, such as the candidate's qualifications, skills, competencies, and proficiency for the role. Information on other benefits may be found on our Careers Page.
Personal Care Specialist
CencoraHeadquartered in Oakville, Ontario, Canada, Innomar Strategies is the country's top patient support provider for specialty pharmaceuticals and a division of Cencora. As an employer
Personal Care Specialist Location:Remote, Ontario, Canada Category:Pharmacy & Clinical widget:Full time Job ID:R266712 Job Details PRIMARY DUTIES AND RESPONSIBILITIES: Serves as the consistent and expert primary contact for patients, guiding and supporting them through reimbursement, copay management, and pharmacy coordination across all phases of their medication journey. Communicates directly with patients to gather information, educating on program services (including injection training, pharmacy options, and coverage support), and empowering patients to navigate their therapy. Coordinates and maintains prescription coverage and renewals, interacting regularly with pharmacies, insurance companies, and other partners to resolve obstacles and ensure timely access to medication. Collaborates with Field Case Managers (FCMs) and the broader care network to deliver seamless onboarding and ongoing patient support. Adapts services for diverse clinic and pharmacy models, connecting with preferred pharmacy teams and biologic coordinators as required by territory. Anticipates potential challenges, proactively problem-solves, and provides tailored guidance and support for each patient. Manages adverse event reporting and takes on additional program support or ad hoc duties as assigned EXPERIENCE AND EDUCATIONAL REQUIREMENTS: Requirements: Bilingualism (English/French) is an asset (requirement for province of Quebec) Experience in customer service setting Assets: Post-secondary education certificate, diploma, or degree (preferred) Experience in reimbursement, call center/pharmaceutical industry, health insurance, or clinical support (asset) Knowledge of medical information, CRM systems (Salesforce), and pharmacy operations (preferred) MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS: Exceptional customer service skills and phone etiquette Detail and results oriented, with strong analytical and organizational skills Excellent time management and sense of urgency Ability to collaborate effectively and work autonomously in a remote home office environment Strong written and verbal communication skills in English and French (for Quebec/New Brunswick) Ability to manage multiple priorities and adapt to change and ambiguity Proficiency with Microsoft Office and confidence using technology Commitment to continuous improvement and adherence to program standards What Cencora offers We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. Full time Salary Range* $48,000 CAD - 74,030 CAD Affiliated Companies: Affiliated Companies: Innomar Strategies




