Careers

We are currently looking for an

Office Manager (32-40 hours)

About the Role

At AM-Pharma, the Office Manager is a real “multi-tasker” with great organizing, coordinating  and supporting skills. You are good at facilitating planning, running an accurate administration and you perform well in a group of highly skilled professionals, even in times of pressure or high workload. You ensure that all supportive tasks in the office are structured efficiently, run smoothly and are well organized and people can rely on your support. The team currently exists of 30 employees and 15 consultants and is expanding very quickly.

Your responsibilities include

• Organizing business trips
• Complex calendar management which requires a proactive and structured approach
• Organization of online and offline meetings and company events
• Contract administration for our legal department
• First point of contact for all facility tasks
• Ensure all office supplies and groceries are always well-stocked
• Answering the phone / welcoming guests / processing post mail
• Administrative support for HR
• Replace Executive Assistant in case of absence
• Taking part in the Company Emergency Response Team (BHV)

Job Requirements include

• Secretarial education / Office Management at MBO+ (post-secondary vocational education) or Bachelor level
• With your great problem-solving skills you like to work for a team of highly skilled professionals of different nationalities
• You have excellent proficiency in Dutch and English, both spoken and in writing
• You can deal with peaks in the planning and a high workload
• You can work independently, and you know how to be service oriented and assertive at the same time
• You can easily switch from simple to complex tasks and vice versa
• You have a well-developed sense of responsibility, are service-oriented and work accurately
• You have working experience with Office 365 for business (Outlook, Sharepoint, Teams, Powerpoint, Word, Excel etc)

AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience.  At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work.  Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

Remuneration
Salary at market level

Company pension scheme (premium is 100% paid by employer)

Mobile phone

1^st class public transportation or travel allowance of Euro 0,19 per km

Start date
As soon as possible, but no later than 1 August 2022

Location
AM-Pharma is located in the brand new World Trade Center Utrecht Central, next to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport. For this position, you are allowed to work from home 1 day a week.

To apply
Please send your CV and cover letter, stating the title of the position you are applying for,
to hr@am-pharma.com

To support the expansion of AM-Pharma’s business, we are currently looking for a

Clinical Scientist

About the role
At AM-Pharma, we are actively conducting a global Phase III program treating critically ill patients with acute kidney injury in partnership with a clinical research organization. In addition, we are in the process of starting clinical research in a second and third indication and this will likely be executed in the same format. We have also started our preparations for commercial readiness that includes the build of the appropriate organization. As Clinical Scientist, you will be asked to support our global drug development activities by:

• Providing scientific, clinical and operational input to clinical development studies with emphasis on protocol-specific and clinical data monitoring activities; this includes (but not limited to) protocol and study design, data review, interpretation and presentation
• Elaborating, reviewing and updating clinical documents including SAP, protocol/amendments, medical review documents, training material, informed consent documents, study reports, PK reports, protocol deviation list, input to data management activities (e.g. electronic data capture, data review plan, case report forms) etc.
• Working with the cross-functional clinical trial teams on design, execution and monitoring of clinical trials as well as data interpretation and communication
• Supporting our Clinical Trial Site Liaisons (EU and US) with clinical input
• Working closely with medical on medical data reviews, coordinating DMC meetings and TSC meetings.
• Supports publications/presentations as needed

What we expect
We expect our Clinical Scientist to have:

• PhD degree in Biomedical (Pharmacology, Biology, Chemical Engineering etc.)
• Relevant experience in clinical development and providing clinical scientific advice
• Excellent interpersonal, verbal and written communication skills
• Ability to plan, organize, prioritize and execute multiple tasks within assigned objectives
• Ability to work effectively in an international matrix team and value the importance of teamwork
• You can deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech
• Fluent knowledge of English (written and oral)
• Advanced knowledge of MS Office (Word, PowerPoint, Excel)

AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience.  At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations, the staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work.  Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

Remuneration
Salary at market level, depending on education and working experience
Company pension scheme (100% contribution by employer)
Mobile phone
Full reimbursement of public transportation or travel allowance of Euro 0,19 per km

Start date
As soon as possible

Location
AM-Pharma is currently located in the brand-new World Trade Center Utrecht Central, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport.

To apply
Please send your CV and cover letter, stating the title of the position you are applying for,
to hr@am-pharma.com

About the role
The Consultant Clinical Trial Site Liaison (CTSL) Australia is responsible for building, managing and supporting site relationships on behalf of the AM-Pharma organization within Australia. This is a position at Director level and will report directly to the VP Clinical Operations. He/she ensures efficient and high-quality recruitment into our clinical studies through interaction with study personnel. She/he will elaborate high quality presentations of scientific data in various settings, including advisory boards, investigator meetings, to enhance product/disease state knowledge. He/she has significant experience facilitating strong relationships with the external scientific and medical community and has a track-record of best practices. He/she engages with Key Opinion Leaders, provides medical support for the brand plans, supports the development strategy and initiatives and programs. He/she runs this position from our offices in Utrecht and will have significant travel mainly to study sites.

What we expect
We expect our Consultant Clinical Trial Site Liaison Australia to:

• Bring a minimum of 10 years of experience in Medical Affairs or Clinical Operations in a GCP/FDA regulated pharmaceutical company; have experience in supporting Phase-III programs.
• Be an MD (PhD) or hold a Master’s degree in Life Sciences with Pharma industry experience (preferably having previous experience in the CTSL or MSL role).
• Have a thorough understanding of applicable federal and state regulatory requirements for field‐based scientific personnel and to keep a successful track record of compliance.
• Have experience/expertise in interpretation of scientific data, market research, competitive intelligence tools, drug information systems, and developing medical educational strategies.
• Have outstanding written and verbal communication/listening and presentation skills.
• Have previous success translating/tailoring complex scientific concepts into simple language for targeted audiences.
• Keep demonstrated problem solving abilities and strong organizational skills.
• Bring a history of great collaboration/teamwork; have a reputation for successful partnering with internal and external stakeholders, including medical opinion leaders, large group practices, medical directors and MCO professionals.
• Have a good understanding of clinical development and commercial environment.
• Have the ability to work successfully in a small organization.
• Be pragmatic, solution-oriented thinker who possesses a “can do” and” whatever it takes” attitude, coupled with excellent organizational and communication skills (verbal, written, listening, conveying messages).
• Have strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
• Be proficient with Veeva and Microsoft Office; in depth Word, PowerPoint & Excel skills.
• Have the ability to travel (60%) within Australia.
• Be available for AM-Pharma on part-time basis (0.5FTE).

AM-Pharma company culture
The company culture of AM-Pharma is built on four important competences: Collaboration, Quality orientation, Accountability and Resilience.  At AM-Pharma we work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. We put the common interest of the company above our own individual interest.
We set high standards regarding the quality of our materials, processes, documentation and collaborations; staff are motivated to deliver excellence whilst also working to continually improve the quality of our work. We are fully accountable for the things that are in our power and control while working on the goals of the organization. We have an obligation to proactively report, explain and justify the things we do. We accept responsibility for our performance and we are transparent about the results of our work.  Finally, we understand how to cope effectively with setbacks and obstacles and overcome hurdles on our way to reach our common goal. We stay committed to agreed objectives and company culture despite resistance while having the strength to adjust our plans when necessary. We are tolerant to stress and we deal effectively with criticism and resistance, building on our own strength.

Remuneration
At market level.

Start date
We expect the candidate to start its employment latest as of Q2 2022.

Location
AM-Pharma main location is in World Trade Center Utrecht Central, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport. For this consultant role, we would expect candidates to work remotely.

About the role
At AM-Pharma, we are actively conducting global Phase III programs treating critically ill patients with acute kidney injury in partnership with a clinical research organization. As Sr. Quality Officer, you support the Sr. Director Quality Management with the design, development and execution of Quality policies and guidelines, the approval of quality documents, review and improvement of the GCP and GMP compliance of the company and with professionalizing the quality systems of the company. You are responsible for

• Reviewing, revising and approving Quality documents through our document change process;
• Reviewing and approving of change requests, deviation reports, complaints and CAPA’s;
• Reviewing and approving of clinical trial reports in case of deviations and complaints;
• Keeping track of change requests, deviations and CAPA’s and closing and archiving of completed documents;
• Reviewing and approving of validation, stability and transfer protocols and reports;
• Conducting audits at vendors, on systems and analytical methods;
• Reviewing and approving of batch documentation, QC results and reports of findings to the QP of AM-Pharma;
• (Co-)executor of audits; executing internal and vendor audits and reporting about the results;
• Setting up systems for mock-recalls and assist in execution;
• Reporting of quality KPI’s and other information for management review purposes;
• Assist with regulatory inspections;
• Designing and improving AM-Pharma’s quality system, including writing new protocols, improving existing protocols and the design and maintenance of databases;
• Providing advice and training to colleagues and peers about GCP, GMP and basic quality systems.

What we expect
We expect our Sr. Quality Officer to keep a Bachelor or Master degree, a completed education in Pharmacy, Bio-pharmaceutical Science, Biochemistry or comparable. The Sr. Quality Officer has

• A minimum of 5 years of experience in a Quality management department in a biopharmaceutical environment;
• Proven knowledge about Quality systems in GMP, and preferably in GCP.
• Understands the dynamics of Clinical Operations including Regulatory and CMC processes and supply chain;
• Ability to work with MS Office software (including Excel, Word, PowerPoint);
• Proficiency in written and spoken English;
• Ability to plan, organize, prioritize and execute multiple tasks within assigned objectives;
• Ability to work effectively in an international matrix team and value the importance of teamwork;
• Ability to deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech;

Remuneration
Salary at market level, depending on education and working experience
Company pension scheme (100% contribution by employer)
Mobile phone and laptop
Full reimbursement of public transportation or travel allowance of Euro 0,19 per km

Start date
As soon as possible

Location
AM-Pharma is currently located in the brand-new World Trade Center Utrecht Central, adjacent to Utrecht Central Railway Station in the lively business heart of Utrecht, close to Amsterdam and Schiphol Amsterdam Airport.

How to apply
Please send your CV and cover letter, stating the title of the position you are applying for,
to hr@am-pharma.com