What Scientific Editors Jobs are in South Africa?

**Work Schedule**
Standard Office Hours (40/wk)
**Environmental Conditions**
Able to lift 40 lbs. without assistance, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials
**Job Description**
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**DESCRIPTION:**
Join Thermo Fisher Scientific as a Warehouse Pharmacist in our Clinical Trials Division to contribute to ensuring the safety, quality, and efficacy of pharmaceutical products. You'll manage end-to-end warehousing operations while upholding the highest standards of Good Pharmacy Practice and Good Wholesale Practice.
In this position, you'll handle clinical trial supplies and process product receipt, release, storage and distribution whilst maintaining regulatory compliance. You'll coordinate logistics, manage drug accountability, and ensure proper documentation of pharmaceutical products and controlled substances. You'll also work with multiple stakeholders to investigate quality-related issues, participate in self-inspections, and contribute to continuous improvement initiatives.
This role supports our organization's core values of Integrity, Intensity, Innovation, and Involvement, offering opportunities to contribute to global healthcare while developing your career in pharmaceutical services.
**REQUIREMENTS:**
+ B-Pharm Degree
+ Mandatory previous experience in a wholesale or clinical trial environment
+ Current registration with the South African Pharmacy Council
+ Knowledge of Good Pharmacy Practice (GPP) and Good Wholesale Practice (GWP)
+ Expert knowledge of pharmacology, drug safety, and regulatory compliance standards
+ Experience with regulatory requirements and quality assurance systems
+ Proficiency in handling controlled substances and maintaining proper documentation
+ Knowledge of import/export requirements for clinical study products
+ Strong understanding of cGWP regulations
+ Experience with environmental monitoring and cold chain maintenance
+ Excellent analytical and problem-solving abilities
+ Strong organizational skills with attention to detail
+ Demonstrated ability to work independently and meet deadlines
+ Proficient computer skills including Microsoft Office suite
+ Strong written and verbal communication skills
+ Strong leadership capabilities, with previous leadership experience and team management
+ Physical ability to:
+ Lift and carry up to 20 kg
+ Work in walk-in freezers/refrigerators
+ Stand for extended periods
+ Work in a warehouse environment
+ Ability to use required personal protective equipment
+ Flexibility to work rotating shifts and occasional extended hours
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Internship **South Africa**
Are you a recent graduate who would like to take his\her first steps within a dynamic clinical research organization? Are you interested in learning fundamental skills to start your career effectively?
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**How will you make an impact?**
The 12-month internship in Clinical Operations is designed to offer you the opportunity to develop insight into clinical research, master your skills while conducting meaningful work within the team. The programme framework is crafted to allow you to grow professionally, learning invaluable skills to help you kick start your career!
**What you will do?**
As part of Clinical Operations, you will work closely as a team, providing support and ideas for day to day activities. Your engagement and level of dedication will ensure that our project teams would receive the administrative and technical support they need. You will have an ambassador who will help you navigate through our organization and processes and receive the best support, which will ensure you are on your way to reaching your goals.
Being part of the Clinical Operations team, you will be introduced to many diverse parts of the company. You will have a wide portfolio of exciting tasks to complete. Plus test your natural curiosity in providing administrative and technical support to the team proactively, educating yourself about the clinical research industry and master your skills to measure your business progress.
**How will you get here?**
+ You possess a health science degree and recently graduated (Within the last 2 years)
+ You have not previously been employed
+ You are looking for an entry level position
+ You enjoy working in a team
+ You have excellent administration and organization skills and the ability to prioritize and handle various tasks timeously
+ You are results oriented
+ You demonstrate a positive demeanor and desire to succeed
+ You exhibit a high degree of flexibility in adapting to a constantly evolving business environment
+ You have English proficiency
_In line with our Employment Equity Plan, preference may be given to suitably qualified male candidates from designated groups (African, Indian, and Coloured) in accordance with the Employment Equity Act. All applications will be considered on the basis of skills, qualifications, and experience._
**Work Environment:**
At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD Clinical Research Services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
Our Mission is to enable our customers to make the world healthier, cleaner and safer.
As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing to life our Mission: enabling our customers to make the world healthier, cleaner, and safer.
We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Effective communication of evidence and information is essential to conveying the value of products. Our highly trained staff provide medical writing services for the peri- and post-approval phases of the product lifecycle, helping to create a consistency in quality and voice. Our writers prepare documents that are clear, concise, compelling, and scientifically accurate, while also ensuring they are fully aligned with regulations, industry standards, and corporate guidance.
**Discover Impactful Work**
The Publications and Scientific Communications team, part of the Medical Writing and Healthcare Communications department at Thermo Fisher Scientific, prepares medical publications, abstracts, posters, presentations, and other scientific communications. Our dynamic, highly collaborative team focuses on providing quality writing to internal collaborators and external pharmaceutical and biotech clients.
**What You'll Do in the Role**
+ Write, edit, and manage **manuscripts, posters, abstracts, oral presentation slide decks, and review articles** , on time, within budget, and with little instruction
+ Raise and help resolve project management issues, such as out-of-scope requests
+ Ensure compliance with quality processes and industry standards
+ Represent the team as the lead contact on projects
+ Lead or provide input on process improvements
**Keys to Success**
We are looking for an expert publication writer to join the team. The Senior Medical Writer will be responsible for leading and producing high-quality publications and scientific communications, from kick-off to completion. The successful candidate will have extensive experience in creating publications, abstracts, and posters, as well as excellent written English and analytical skills. We seek a bright teammate who is proactive, enjoys challenges, and can thrive in a highly collaborative CRO (contract research organization) environment.
**Education, Experience & Skills**
+ Extensive proven experience as a writer of peer-reviewed medical publications
+ Experience working in a CRO environment preferred
+ Experience of generating publication extenders (e.g., plain language summaries, video/graphical abstracts) advantageous
+ Experience of publication planning/strategy advantageous
+ Excellent scientific writing, project management, and digital literacy
+ Bachelor's degree or higher in a scientific field; advanced degree preferred
+ In-depth knowledge of different therapeutic areas
+ Additional qualifications (e.g., EMWA or CMPP certification) advantageous
+ Sound professional judgement in dealing with inquiries, issues, and customer concerns
+ Able to independently make decisions and solve problems
+ Comfortable working on multiple projects concurrently
+ Able to prioritize and delegate tasks effectively
+ Able to complete work within fixed budgets and timelines and to facilitate conflict resolution among team members and clients
**Physical Requirements / Work Environment**
+ Work will be 100% remote (home based)
+ Occasional domestic and international travel may be required
**Why Join Us?**
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or any other legally protected status.
**NOTE: Please include in your application a cover letter describing your qualifications for the role.**
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Other
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Location/Division Specific Information**
PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customers key functions. We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.
**Discover Impactful Work:**
Joining within our PPD FSP functional area, allows you to join the renowned PPD CRO and still gain invaluable client dedicated experience.
**A day in the Life:**
As a Clinical Research Associate, you will:
+ Thrive in multi-national project teams and be focused on delivering exemplary levels of customer service on multiple, challenging projects.
+ Have excellent communication and interpersonal skills and are looking to work in a collegiate environment where you want to take true ownership for your work.
+ Perform and coordinate all aspects of the clinical monitoring process. You shall also be qualified to conduct monitoring activities independently.
+ Benefit from award winning training programmes that will assist your technical and professional skills and knowledge.
**Keys to Success:**
**Education**
+ University degree in a life-sciences field
**Experience**
+ At least 6 months independent, on-site monitoring experience in a Pharmaceutical or Clinical Research Organisation
**Knowledge, Skills, Abilities**
+ Demonstrated understanding of ICH-GCP, EU and FDA requirements
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Exceptional communication, collaboration, organisational and time management skills
+ Excellent command of English and local languages
**Benefits**
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
"Severely disabled applicants with the same aptitude will be given preferential treatment. / Schwerbehinderte Bewerber werden bei gleicher Eignung bevorzugt behandelt."
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
**Apply today! Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
**Accessibility/Disability Access**
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Warehouse
**Job Description**
At Thermo Fisher Scientific - BioServices, we specialize in the management of critical biological materials in support for the advancement of cell therapy, high value biologics, and population-based public health research. We provide customized end-to-end chain of custody solutions for our large pharmaceutical clients and partners in academia and government, ensuring the integrity and efficacy of their valued material from the manufacturer to the bedside.
**POSITION SUMMARY:**
We are seeking a qualified Post-Basic Pharmacist Assistant (Pharmacy Technician) to join our BioServices (ICRPMC) team on a 12-month fixed-term contract, with the possibility of permanent appointment.
This role is ideal for a detail-oriented professional with experience in pharmaceutical distribution, clinical trial logistics, or warehouse operations, looking to contribute to high-impact clinical research programs.
**KEY RESPONSIBILITIES:**
You will support daily operations, including:
+ Preparing and coordinating shipment documentation for pharmacist review and approval
+ Receiving, inspecting, and documenting clinical research product shipments
+ Managing storage and handling of investigational products and related materials
+ Processing site orders using inventory systems (e.g. COSMOS)
+ Packing and dispatching temperature-controlled shipments to clinical trial sites
+ Maintaining cold chain integrity (ambient, refrigerated, frozen conditions)
+ Supporting inventory control, including stock counts and system reconciliation
+ Conducting environmental monitoring (temperature, humidity, storage conditions)
+ Maintaining accurate documentation, scanning, and filing systems
+ Supporting labelling operations for clinical trial materials
+ Liaise with internal teams, clinical trial sites, suppliers, and couriers
+ Support continuous compliance with SOPs, GxP standards, and training requirements
**MINIMUM REQUIREMENTS**
**Qualifications:**
+ National Senior Certificate (Grade 12)
+ Post-Basic Pharmacist Assistant qualification
+ Registered with the South African Pharmacy Council (SAPC)
**Experience:**
+ Minimum 2 years' experience in pharmaceutical distribution or wholesale environments.
**Skills & Competencies:**
+ Requires excellent analytical, research, written, editing, interpersonal and verbal communication skills.
+ Requires skills in medical discipline, proficiency with computer word processing.
+ Requires proficiency using Internet tools to obtain technical reports from Government and other Web sites.
+ Requires ability to effectively work and communicate with staff and project personnel on technical issues.
+ Requires strong organizational skills, detail oriented, and ability to work with multiple projects
**Working Environment:**
+ Warehouse and clinical research repository environment
+ Regular handling of temperature-sensitive materials (cold chain)
+ Use of personal protective equipment and adherence to safety protocols
+ Ability to lift and move materials (up to 23kg)
+ Periodic work in cold storage environments (freezers/refrigerators)
**WHY JOIN US?**
As part of the Thermo Fisher Scientific team, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**About Thermo Fisher Scientific:**
At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds have a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
When you're part of Thermo Fisher Scientific, you'll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best.
Thermo Fisher Scientific provides industry leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes through our Patheon brand.
**Location/Division:** Thermo Fisher Scientific, Clinical Trials Division, Centurion, Gauteng, South Africa
**Reports To:** Client Services / Project Manager
**Position Objective:**
The Associate Project Manager supports our customers through ensuring important clinical trial supplies are delivered in accordance with the company or client specific policies and procedures within client delivery timelines, leading all aspects of the clinical study requirements from study setup, through to study close out.
The holder of this position will, with limited supervision and with appropriate training on software tools and processes, be capable of coordinating day to day activities with high levels of accuracy. The position highly impacts on the efficiency and smooth workflow of the customer experience. The holder of this position is independent in carrying out assigned tasks and is encouraged to practice continuous self-training on processes, quality procedures, have the knowledge and confidence to identify areas for improvement and with limited oversight initiate solutions to achieve our service goals.
**What will you do?**
+ Lead and co-ordinate all technical service aspects of a clinical trial project, ranging from discussions with global project managers on the development of project specifications, documentation aspects of setting up projects and management of all related activities through to completion.
+ Coordinate and communicate all relevant activities, both internally and externally to ensure all aspects of services are in accordance with study requirements.
+ Ensures clinical supplies are stored and distributed in accordance with approved procedures and policies, cGxP and regulatory requirements as stipulated for each clinical study requirement.
+ Overall responsibility for ensuring that activities come together in a timely manner to meet the client's and study requirements.
+ Timely revision of reports and other information to customers or global project managers as required.
+ Participate in client and study related meetings, teleconferences where appropriate.
+ Assist in maintaining FCS SA's Quality System in compliance with Fisher Clinical Services' approved procedures and policies, cGxP and regulatory requirements as applicable when leading the day to day activities for each clinical study.
+ Assist in the investigation of internal and external complaints through to resolution where required.
+ Ensure all required client requests are processed according to internal procedures and timelines
+ Design important metric reports to supervise daily and monthly performance.
**How will you get here? Education**
+ Grade 12 or equivalent
+ Certificate or Diploma in Business Administration, Customer Service preferable
+ Minimum of 3+ years' experience in similar position with focus Customer Service Administration
**Knowledge, Skills, Abilities**
+ Experience working in the pharmaceutical industry will be beneficial
+ A hands-on, hard-working and motivated individual who can work independently, with ability to multi-task, and lead/triage priorities
+ Strong interpersonal and communication skills and the ability to connect positively all levels of an organization, the customer and key suppliers
+ Conscientious
+ Customer-centricity and focused
+ Quality mindset and right-first-time approach
+ Efficient in software packages (Microsoft office)
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Clinical Research Associate (Level I/II) - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to perform and coordinate all aspects of the clinical monitoring and site management process. As a Clinical Research Associate (Level II), you'll conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will manage procedures and guidelines from different sponsors and/or monitoring environments (i.e., FSO, FSP, Government, etc.). Acting as a site processes specialist, you will ensure that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs to guarantee subjects' rights, well-being, and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to your role are outlined in the task matrix.
What You'll Do:
- 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.
- Participates 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. Performs 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.
- 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).
- 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 the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
- Contributes to other project work and initiatives for process improvement, as required.
Education and Experience Requirements:
- Bachelor's degree in a life science related fieldor a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ **Total experience:** at least 3 years as a CRA
+ **Oncology experience:** at least 2 years of on-site, hands-on experience
+ **Location:** central Poland
- Valid driver's license where applicable.
Knowledge, Skills and Abilities:
- Proven clinical monitoring skills
- Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents
- Well-developed critical thinking skills, including but not limited to: critical mindset, in-depthinvestigation for appropriate root cause analysis and problem solving
- Ability to manage Risk Based Monitoring concepts and processes
- Good oral and written communication skills, with the ability to communicate effectively with medical personnel
- Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues
- Good organizational and time management skills
- Effective interpersonal skills
- Attention to detail
- Ability to remain flexibile and adaptable in a wide range of scenarios
- Ability to work in a team or independently as required
- Good computer skills: solid knowledge of Microsoft Office and the ability to learn appropriate software
- Good English language and grammar skills
- Good presentation skills
Working Conditions and Environment:
- Work is performed in an office/ laboratory/clinical/and/or home office environment with exposure to electrical office equipment.
- Frequent drives to site locations. Frequent travel, generally 60-80% but more for some individuals. May also include extended overnight stays.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Personal protective equipment required such as protective eyewear, garments and gloves.
- Exposure to fluctuating and/or extreme temperatures on rare occasions
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Country Approval Specialist - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy
What You'll Do:
- Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SIA services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD's target cycle times for site.
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education and Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good computer skills and the ability to learn appropriate software
- Good English language and grammar skills
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
Working Conditions and Environment:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal protective equipment required such as protective eyewear, garments and gloves
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.