Mgr, Ssu & Regulatory, Fsp Apac

2+ years

Not Disclosed

Remote Australia

10 Dec. 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, Site Start-Up & Regulatory
Location: Australia-Asia Pacific (Home-Based)
Job ID: 24006330
Updated: November 28, 2024

Job Description

Manager, Site Start-Up & Regulatory
Syneos Health® is a global leader in biopharmaceutical solutions, dedicated to accelerating customer success. By leveraging unique clinical, medical affairs, and commercial insights, we address the modern realities of the market.

Our Clinical Development model places the customer and patient at the center of everything we do. We continuously seek ways to simplify and streamline our processes to ensure that Syneos Health is not only easier to collaborate with but also a great place to work for.

In both Functional Service Provider partnerships and Full-Service environments, you will join passionate problem solvers, collaborating as a team to help our customers achieve their goals. We are agile, motivated to accelerate therapy delivery, and deeply passionate about changing lives.

Join our global team of 29,000 employees across 110 countries and experience firsthand why WORK HERE MATTERS EVERYWHERE.

Why Syneos Health?

We are committed to developing our people by providing career growth opportunities, technical and therapeutic area training, and a strong focus on employee well-being. Our Total Self culture embraces authenticity, diversity, and inclusion, ensuring everyone feels valued.

Job Responsibilities

Oversee people management activities, including hiring, terminations, professional development, performance reviews, and employee counseling.
Provide guidance on administrative policies, technical issues, and process methodologies.
Act as a liaison between customer leaders and senior management, coordinating resources and priorities.
Support site start-up, maintenance, and financial management, with a focus on process improvements.
Assist with project and departmental reviews, monitoring budgets, schedules, and risk analysis.
Develop and deliver training programs for departmental teams.
Collaborate with executive management and the Legal Department on site contracts, start-up, and regulatory workflows.
Implement and maintain enterprise project management systems and tools.
Contribute to the creation and implementation of Standard Operating Procedures (SOPs) and Work Instructions (WIs) for existing and new processes.
Ensure quality control across departmental teams.
Represent the company at professional meetings and seminars.
Establish and maintain training materials for assigned teams.

Qualifications

Bachelor’s Degree or equivalent experience.
Experience in clinical research, particularly in site start-up and contract management.
Strong knowledge of regulations, drug development processes, and clinical project management.
Excellent interpersonal, presentation, and documentation skills.
Proficiency in MS Office, MS Project, email, and internet use.
Ability to manage multiple tasks and meet deadlines in a dynamic environment.
Strong leadership and line management abilities, with a focus on coaching and performance management.
Ability to address and improve underperformance when necessary.

About Syneos Health

In the past five years, Syneos Health has supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000 trial participants.

At Syneos Health, we encourage initiative and innovation in a competitive, ever-evolving environment. Learn more about us and our impact.

Additional Information:

The tasks, duties, and responsibilities listed in this job description are not exhaustive and may be subject to change based on business needs. The company reserves the right to assign other tasks or responsibilities. Equivalent experience, skills, or education will be considered as part of the recruitment process. Syneos Health is committed to equal opportunities and workplace diversity and complies with all applicable local legislation, including the ADA and EU Equality Directive.

Apply Now

Not ready to apply?
Join our Talent Network to stay connected with future opportunities.

Syneos Health is an equal opportunity employer. If your qualifications don’t exactly match the position, we encourage you to apply anyway. Transferrable skills from previous roles are always considered.

Latest Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Argentina | Peru |

Brazil :

Brazil | Sao paulo |

Attica :

Koropi | Athens |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Estonia | Tartu |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Japan | Saitama |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

New Mexico | Ciudad de México |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Paris | Lyon |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Mgr, Ssu & Regulatory, Fsp Apac

Job Description

Job Description

Why Syneos Health?

Job Responsibilities

Qualifications

About Syneos Health

Additional Information:

Apply Now

Latest Jobs

Medical Review Officer

Senior Medical Safety Analyst - Nutrition - Columbus

Associate Clinical Site Lead

Clinical Site Lead - Los Angeles

Medical Director, Crm Medical Affairs

Patient Therapy Access Specialist

Patient Therapy Access Specialist

Senior Statistician

Global Director, Clinical Insights Development

Senior Field Clinical Specialist

Pharma Jobs in India

Pharma Jobs in United States

Pharma Jobs in Germany

Pharma Jobs in Europe

Pharma Jobs in Ireland

Pharma Jobs in China

Pharma Jobs in Netherland

Pharma Jobs in Australia

Pharma Jobs in United Kingdom

Pharma Jobs in England