Open Vacancies at Thermo Fisher Scientific

Job Description

• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assess investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
• May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).
• Performs QC check of reports generated from CTMS system where required.  in investigator meetings as necessary.
• Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
• Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.
• Ensures trial close out and retrieval of trial materials.
• Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.
• Conducts on-site file reviews as per project specifications. Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
• Performs additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).
• Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts. Responds to company, client and applicable regulatory requirements/audits/inspections.
• Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner. Contributes to other project work and initiatives for process improvement, as required.

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A day in the Life:

• Writing fully-referenced content for global value dossiers and related deliverables, health-technology assessment (HTA) submissions, based on published clinical, scientific, and pharmacoeconomic literature
• Developing simple visuals and graphics (e.g., in Excel or PowerPoint)
• Editing, quality assurance, and formatting
• Acting as the lead writer on project teams
• Daily communication and teamwork with colleagues in the Market Access Communications team and with subject matter experts in other Evidera groups
• Project leadership/management for small- to moderate-scale projects
• Frequent interaction with clients to understand their expectations and to receive their feedback
• Business development for small- to moderate-scale projects
• Workload management to meet internal and client-driven deadlines 

Keys to Success:

• The successful candidate is a highly motivated, detail-oriented, and organized self-starter who works well independently and on teams. Enthusiasm for a professional writing career and excellent verbal and written communication skills are essential.

Knowledge, Skills, Abilities

• Experienced in medical/scientific writing with a focus on accuracy and quality
• Ability to understand and clearly convey complex clinical, economic, and commercial information, after receiving appropriate training on new content areas
• Research and analysis skills, e.g., ability to undertake reviews of the scientific literature
• Exquisite attention to detail
• Knowledge of the pharmaceutical industry and drug development process
• Familiarity with clinical trials and basic biomedical statistics
• Comfort in a client-facing role
• Familiarity with Microsoft Word, PowerPoint, and Excel
• Strong time management skills and ability to work simultaneously on multiple projects 

It is helpful, but not essential, to have:

• Understanding of market access and health economics
• Experience with bibliographic referencing software
• Desire to move towards increased project leadership and client interaction

Education & Experience

• 3+ years agency or consultancy experience in a market access or medical writing role.
• Advanced degree in life sciences, health economics, or a clinical discipline is preferred, e.g., PhD, PharmD, MD, MPH, MS. Experienced candidates with a BS/BA are also welcome to apply.

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Job Description

• Composes, copies and distributes correspondence and memoranda, reports, documents, forms and tables as requested 
• Inventories, orders and distributes office supplies 
• Sorts and distributes incoming mail, correspondence and other printed material 
• Maintains calendar of the manager and ensures the manager remains on schedule and properly prioritized throughout the day given the changing business requirements 
• Arranges travel schedule and reservations and prepares expense reports and ensures submission in a timely fashion 
• Coordinates details of onsite and offsite meetings and conferences including catering needs 
• Collects, compiles and prepares presentations, reports, meetings agendas and other documents; establishes, organizes and maintains files. 
• Cooperates and coordinates with administrative assistants in other departments to handle temporary work overloads and fill in for temporary absences

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Job Description

• According to the specific role (Central or Local), coordinates, oversees and completes functions on assigned trial(s) activities as detailed on the task matrix.
• Performs department, Internal, Country and Investigator file reviews as assigned, and documents findings in appropriate system(s).
• Ensures allocated tasks are performed on time, within budget and to a highquality standard.
• Proactively communicates any risks to project leads.
• Provides system support (i.e., Activate & eTMF) and ensures system databases are always current.
• Performs administrative tasks on assigned trials, including, but not limited to, timely processing of documents sent to Client (e)TMF as assigned, performing (e)TMF reviews, distributing mass mailings and communications as needed, providing documents and reports to internal team members.
• Analyzes and reconciles study metrics and findings reports.
• Assists with clarification and resolution of findings related to site documentation.
• Assists with coordination, compilation and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
• Assists with study-specific translation materials and translation QC upon request.
• Maintains knowledge of and understands SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
• Where applicable, conducts on-site feasibility visits (Asia Pac only).
• May support scheduling of client and/or internal meetings.
• May review and track of local regulatory documents.
• May provide system support (i.e., Activate & eTMF). May support RBM activities.
• May support the maintenance of study specific documentation and systems, including, but not limited to, study team lists, tracking of project specific training requirements, system access management and tracking of project level activity plans in appropriate system(s).
• Transmits documents to client and centralized IRB/IEC.
• Maintains vendor trackers.
• Supports start-up team in Regulatory submissions.
• Works directly with sites to obtain documents related to site selection.
• Assists the project team with the preparation of regulatory compliance review packages.
• Provides support as needed to coordinate with internal departments, ensuring site start-tup activities within the site activation critical path are aligned.
• May complete the ‘Site Interest Plan’ in CTMS and collection and delivery of associated documents from investigators and site personnel.
• Documents in real time all communication, attempts an follow up associated with site contact and survey responses.
• Supports the review of survey data to ensure responses are logical, complete and reflective of the question asked.
• Works in collaboration with teammates to achieve targeted deadlines for assigned projects. Communicate with the team and appropriate clinical personnel regarding site issues and risks.
• Ensures an efficient, effective plan is in place for site contact and follow up.
• Ensure compliance with the plan and escalate concerns/non-compliance to management.
• May act as the local expert regarding site capacity and experience. Work with key local personnel to gather knowledge base and recommend additional sites.
• Harness this knowledge base when performing local tiering of sites.
• Liaises with Global Investigator Services to resolve investigator queries in real time and maintain ‘accounts and contact’ information.
• Contributes to the development and roll-out of global strategic feasibility processes and best practices.
• Trains new personnel in processes and systems.
• Utilizes local knowledge to contribute to the identification and development of new sites.

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Responsibilities:

• Perform all job responsibilities in a manner consistent with our 4i Values (Integrity, Intensity, Innovation, and Involvement)
• Act as Compliance business partner to the region by continually providing advice and guidance to the business on compliance risks associated with business decisions. Take oversight of key decision points to ensure appropriate decisions are made on critical activities.
• Support the EMEA Compliance Director to foster ethical behavior by taking lead of various compliance projects to ensure the Middle East & Africa (MEA) growth continues on the right track.
• Work closely with the Internal Audit team to support investigations; support annual risk assessment and follow up the remediation action.
• Support and conduct screening and other due diligence on third party engagements.
• Develop and enforce compliance policies and SOPs and conduct training to ensure policy comprehension and effective implementation.
• Conduct compliance reviews and approvals on various activities.
• Monitor and identify compliance risks, coordinate control improvements to mitigate those risks, and monitor or audit implementation and effectiveness of those controls.

Qualifications:

• Minimum 3 years of work experience directly relevant in Compliance and/or Operations with substantial exposure to FCPA and UK Anti-Bribery Act, preferably in the pharmaceutical/medical device industries or other healthcare industry.
• Bachelor degree or above. Legal background is preferred. Advanced degree, CPA certification, UK Bribery Act certification, audit experience or Juris Doctorate a plus.
• Thorough working knowledge of anti-corruption compliance and regulatory affairs (familiarity with trade compliance, import/export affairs or tax/money laundering affairs are beneficial).
• Excellent communication and interpersonal skills.
• Strong ability in working independently and under pressure, can-do attitude and self-motivated with bias for action.
• Proven integrity and high ethical standards.
• Excellent communication in English is necessary. (Additional regional language beneficial)
• Good at managing and coordinating relationships and interactions with various departments and teams.
• Strong competence in strategic planning and execution of commercial compliance programs.
• Ability to travel regionally 0-5%; globally once or twice a year.