Managing Counsel

2 weeks ago

Charlotte, United States Syneos Health Full time

Description

Managing Counsel

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

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 our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
* We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Summary:

Syneos Health is looking for a detail-oriented regulatory attorney to join its Legal team. The successful candidate will be a self-starter with excellent judgment and significant experience advising clients on laws, regulations, and industry standards governing clinical development and commercialization of pharmaceutical products.

Job Responsibilities:

* Responsible for providing legal regulatory advice and counsel on global regulatory and clinical development matters.

* Assists Head of Legal Regulatory with the strategy and implementation of the Legal Regulatory function in alignment with departmental and functional goals and company strategy.

* Provides legal and regulatory advice to Corporate Quality and the clinical business on quality-related issues, regulatory authority inspections, client and internal audits.

* Provides legal support to Dispute Resolution team on litigation and pre-litigation matters as appropriate.

* Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research.

* Provides legal support for communications with regulatory agencies.

* Provides legal support for compliance and quality investigations as appropriate.

* Assists Head of Legal Regulatory in advising the business on new and modified service offerings.

* Supports regulatory due diligence in connection with potential M&A or other business transactions.

* Keeps abreast of legislative and regulatory changes that may affect the company and its customers.

* Advises on regulatory and Quality Assurance commitments in clinical and commercial agreements.

* Works collaboratively across the Legal department, including the Company's global team of regional-based attorneys, in providing legal regulatory advice, building consensus on process improvements, and driving corporate legal projects to completion.

* Supports the Syneos Health 'Mission, Vision and Values.'

Qualifications

What we are looking for:

* Fully qualified lawyer.

* 8+ years of experience advising on legal and regulatory matters in the pharmaceutical research and development space.

* Broad understanding of the clinical trials regulatory framework, with awareness of key differences across international jurisdictions.

* Strong working knowledge of GxP requirements applicable to clinical research, with a particular focus on GCP and GVP.

* Ability to communicate clearly, concisely, and professionally with all levels of management regarding complex regulatory issues.

* Experience working in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development company.

* Ability to work independently while being able to contribute successfully to cross-functional teams.

* Independent judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters in a fast-paced environment.

* Can-do attitude, ability to work under pressure and to manage the expectations of clients.

* Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.

* Sense of humour is a plus.

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

PDN-9b8504b6-e8e3-4686-a04a-813a0a65678f

  • Claims Counsel

    3 weeks ago

    Charlotte, United States Carolina Legal Staffing Full time

    We are working with a Company on a search for an experienced In-House Insurance Claims Counsel for their corporate legal department located in uptown Charlotte. The company is a group of property/casualty insurance companies writing a wide variety of commercial, personal, admitted and surplus lines insurance business nationwide with offices in Charlotte,...

  • Claims Counsel

    1 week ago

    Charlotte, United States Carolina Legal Staffing Full time

    We are working with a Company on a search for an experienced In-House Insurance Claims Counsel for their corporate legal department located in uptown Charlotte. The company is a group of property/casualty insurance companies writing a wide variety of commercial, personal, admitted and surplus lines insurance business nationwide with offices in Charlotte,...

  • In-House Claims Counsel

    3 weeks ago

    Charlotte, North Carolina, United States Capstone Search Group Full time

    About the RoleCommercial admitted and surplus lines group of property/casualty insurance companies seeking an experienced In-House Insurance Claims Counsel for their corporate legal department. Join a corporate culture that is collaborative, collegial, professional, and fast-paced. This position provides a wide range of legal support to the company's claim...

  • In-House Claims Counsel

    2 weeks ago

    Charlotte, United States Capstone Search Group Full time

    About the Role Commercial admitted and surplus lines group of property/casualty insurance companies seeking an experienced In-House Insurance Claims Counsel for their corporate legal department. Join a corporate culture that is collaborative, collegial, professional, and fast-paced.  This position provides a wide range of legal support to the...

  • Manager & Assistant General Counsel, MSO ASC Strategic Partnerships

    20 hours ago

    Charlotte, United States Novant Health Full time

    Overview The Manager & Assistant General Counsel, MSO ASC Strategic Partnership role provides legal advice and counsel in the areas of joint ventures and other endeavors related to Novant Health Enterprises, a division of Novant Health. This role supports operations and compliance of Novant's joint ventures related to the provision of patient care outside...

  • Regional Sales Manager

    2 weeks ago

    Charlotte, United States Dealervero Full time

    Regional Sales Manager Job Duties:Accomplishes regional sales human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees in assigned districts; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing...

  • MST Program Manager

    6 days ago

    Charlotte, United States NC Health Partners Full time

    Job DescriptionJob DescriptionOverviewNC Health Partners is looking to hire a MST Program Manager who has at least 2 years of MST supervisor experience and/or a minimum of 4 years of MST Therapist experience. The MST Program Manager will oversee the day-to-day operations of the MST program and ensure the integrity of the program model. Key...

  • Life Coach

    4 weeks ago

    Charlotte, United States INLIVIAN Full time

    Job DescriptionJob DescriptionTitle: Life Coach (Case Manager) - (All programs FSS, MTW, Hope VI etc.) Reports To: Program Manager Department/Division: CORE FLSA Status: Exempt Position Summary Responsible for developing and delivering a broad range of counseling and referral services for low-income participants in assigned client services program(s),...

  • Property Manager

    3 days ago

    Charlotte, United States INLIVIAN Full time

    Job DescriptionJob DescriptionTitle: Property Manager Reports To: District ManagerDepartment/Division: Blue HorizonFLSA Status: ExemptPosition SummaryResponsible for overall management, maintenance, operations, admissions, and profitability of one or more multifamily communities. The incumbent will provide regular reports on fiscal and occupancy status and...

  • Counselor, Early College

    6 days ago

    Charlotte, United States Charlotte-Mecklenburg Schools Full time

    Summary: Utilizing leadership, advocacy, and collaboration, school counselors promote student success, provide preventive services, and respond to identified student needs by implementing a comprehensive school counseling program that addresses academic, career, and social/emotional development for all students. The major functions of the school...

  • Counselor, School

    3 days ago

    Charlotte, United States Public School of North Carolina Full time

    Summary Utilizing leadership, advocacy, and collaboration, school counselors promote student success, provide preventive services, and respond to identified student needs by implementing a comprehensive school counseling program that addresses academic, career, and social/emotional development for all students. The major functions of the school counselor job...

  • Seeking an AUDIT MANAGER

    2 days ago

    Charlotte, North Carolina, United States gpac Full time

    One of my best CPA firms is adding an AUDIT MANAGER to their team The benefits package includes a competitive salary, which is based on experience (plus discretionary bonus) commensurate with experience, health insurance, vacation/sick pay, retirement plan, and realistic work/life balance.Job detailsJob Type: Full-timeBenefits: Bonus, Health, Vacation, Sick...

  • General Sales Manager

    4 days ago

    Charlotte, United States Interactive One Full time

    **General Sales Manager** Location: **NC Charlotte** **Description** **General Sales Manager** Manages sales team and maximizes revenues through inventory management and serving customer needs. **Qualifications:** * Bachelor's degree (B. A.) from four-year college or university; * Two to four years related experience and/or training; or equivalent...

  • Employee Assistance Program Counselor

    2 weeks ago

    Charlotte, United States Atrium Health Full time

    Overview Job Summary Provides evaluation, referral, emergency and follow up services for both internal employees of Atrium Health as well as external employees of companies with which we contract EAP services. Assists employees and their families cope with work, medical, social, emotional, substance, legal, and other personal problems which they may be...

  • Tax Manager

    6 days ago

    Charlotte, United States Sherpa | Recruiting, Staffing & Consulting Full time

    Compensation: $125k plus bonus Position Summary Job Overview – Tax Manager – 32501 Prestigious Registered Investment Company, headquartered in Charlotte, seeks Tax Manager. This new role leads all tax compliance, tax planning, and tax structuring for the company’s investment entities and reports to the company CFO. The ideal candidate will have prior...

  • Onsite Manager

    1 week ago

    Charlotte, United States JobsRUs.com Full time

    Are you goal oriented, have a passion for people, are great at multitasking and have the drive to thrive with a company? If so, apply today to be considered for an Onsite Manager position in Hunt Valley, MD Customer Service, Servers, Bartenders please apply as this is a great transition into an HR Management Career! Schedule: Monday-Friday 8p - 4a (Could be...

  • Licensed Mental Health Professionals

    2 weeks ago

    Charlotte, United States HCO Behavioral Health Full time

    Job DescriptionJob DescriptionSalary: $43.00-$60.00 hourlyLicensed Mental Health Professionals (Telehealth Positions)Company Overview:We are an emerging group provider practice specializing in telehealth services, committed to providing accessible and high-quality mental health care to individuals across the United States. Our comprehensive services include...

  • Property Manager

    4 weeks ago

    Charlotte, United States INLIVIAN Full time

    Job DescriptionJob Description: Title: Property Manager (RAD)Reports To: District ManagerDepartment/Division: Operations/Property & Asset ManagementFLSA Status: ExemptNO PHONE CALLS PLEASEPosition SummaryResponsible for overall management, maintenance, operations, admissions, and profitability of one or more multifamily communities. The incumbent will...

  • Substance Use Counselor

    3 weeks ago

    Charlotte, United States Mecklenburg County Full time

    Position Specific Information This position is located full time onsite at the Mecklenburg County Detention Center in uptown Charlotte, NC 28202. Candidates are required to be credentialed or licensed in North Carolina with the NCASPPB as either full CADC, full LCAS, or LCAS-A.The full time position hours are Monday – Friday, 8 am to 5 pm onsite.The...

  • Front Office Manager

    7 days ago

    Charlotte, United States GF Management Full time

    Located in the thriving Birkdale area, the Courtyard Charlotte Lake Norman welcomes business and leisure travelers alike. With spacious guest rooms featuring mini-refrigerators, microwaves, and complimentary wi-fi internet access, you have found your new favorite Huntersville hotel. For your meeting needs, the hotel offers a 1,000 sq. ft. of meeting room...