Careers

At AM-Pharma, the Associate Director Regulatory Affairs plays an important role in bringing to market our potential life-saving medical treatment. You will have the opportunity to work together with a team of professionals within our collaborative and positive company culture.

Reporting into the VP of Regulatory Affairs and Quality Management, you will:

• Manage the preparation and compilation of BLA/MAA submissions in US, EU and Japan
• Manage the filing of CTAs including management of responses to authority questions and submission of CTA amendments together with the clinical development team and the CRO
• Assemble and maintain clinical, nonclinical and CMC development information repository to allow efficient retrieval of development reports, protocols, specifications, and other relevant documentation
• Manage Paediatric Investigation Plan (PIP) activities, including iPSP follow-up in the US
• Bring up-to-date knowledge on regulatory guidelines, document management and archiving policies and share this with the development team;
• Coordinate and support the interaction with (inter)national health authorities, agency meetings and prepare contact reports and meeting minutes
• Support the team with developing regulatory strategies and contribute to scientific advice
• Write, review scientific and clinical development reports for regulatory compliance

What we expect

We expect the Associate Director Regulatory Affairs to

• Bring relevant regulatory experience in a drug development setting
• Have the ability to handle multiple tasks efficiently and effectively
• Have good communication skills with ability to work in a small and professional team environment
• Have strong interpersonal skills and high attention for detail
• Be proficient in English

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 and the patient 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. 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 in Q3 2021.

Location
AM-Pharma is located in the brand-new WTC Utrecht, 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

We are currently looking for an

Executive Assistant (32 – 40 hours)

About the Role

At AM-Pharma, the role of Executive Assistant is a new role. You will to support the Executive Team of 4 people of which the CFO is US-based. You have great organizing, coordinating and supporting skills and can professionally communicate with a range of internal and external contacts, representing AM-Pharma. You are good at planning 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 are structured efficiently, run smoothly and are well organized. And most important, you enjoy it!

Your responsibilities include

• Organizing business trips
• Complex calendar management which requires a proactive and structured approach
• Organization of online and offline meetings including Town Halls and team events
• Attend Executive team meetings and Management team meetings, take minutes and pro-actively follow up on action points afterwards
• Logistical and technical support to ensure fluid Supervisory Board (RvC) Meetings
• Set-up content and maintain CRM system with new contacts
• Wide-ranging set of project related tasks to support the C-suite
• Write correspondence and create or review presentations
• Replace the office manager in case of absence
• Taking part in the Company Emergency Response Team (BHV)

Job Requirements include

• Secretarial education / Office Management at HBO, Associate degree 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 communication skills to deal with international visitors and external partners
• You have outstanding language skills; fluent in both written and spoken English and Dutch language
• You can deal with peaks in the planning, a high workload and the ad-hoc and fast paced nature of biotech
• You can handle sensitive and confidential information very well and display a high level of integrity
• You can work independently in a small team
• 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 are willing to work outside office hours when necessary because of the time difference
• 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 range 3.400-4.400 Euro per month for a full-time employment
• 8% holiday allowance
• Company pension scheme (premium is 100% paid by employer)
• Mobile phone
• 1^st class public transportation

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. 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

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 25 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
• First point of contact for all facility tasks
• Ensure all office supplies, IT 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
• 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

Location
AM-Pharma is 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. For this position, you are allowed to work from home 1 day a week.

About the role
The Clinical Trial Site Liaison (CTSL) NA is responsible for building, managing and supporting site relationships on behalf of the AM-Pharma organization within their assigned territory (US and Canada). 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 Clinical Trial Site Liaison NA to:

• Bring a minimum of 10 years of experience in Medical Affairs or Clinical Operations in a GMP/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%).

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
At market level.

Start date
We expect the candidate to start its employment latest as of Q4 2021.

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 US employment, we would expect candidates to work remotely.

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

Pharmacovigilance Associate (20 – 40 hours)

About the setting

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. The pharmacovigilance is conducted by our partner and AM-Pharma provides the oversight. 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 pharmacovigilance organization. The Pharmacovigilance Associate reports into the Chief Medical Officer and will work closely together with the internal operational team and the pharmacovigilance organization of the CRO partner.

About the role
The Pharmacovigilance Associate

• Provides oversight to rapidly and timely processing of new and follow-up reports of adverse events and side effects (Adverse Events, or AE’s), as well as Serious Adverse Events (SAE’s) and Suspected Unexpected Serious Adverse Reactions (SUSAR’s) which are unexpected SAE’s with (possible) causality to the (study) drug, out of clinical drug research.
• Reviews the content of SAE reports for completeness, consistency, and medical plausibility.
• Focuses specifically and critically on SA events where a causal relationship is suspected or reported.
• Liaises with the external project Drug Safety Physician(s) and internal medically qualified staff to assure timely detection and proper interpretation of potential safety signals.
• Provides oversight to the processing all the AE’s, SAE’s and SUSAR’s in the Global Safety Database according to the applicable Company Policies and Standard Operating Procedures (SOP’s), and as required by the competent Authority for reporting adverse events.
• Provides oversight to timely reporting of the reportable serious adverse events to the relevant competent authorities and, in the event that the adverse events and site effects arise from clinical trials to ethics committees and / or Data Monitoring Committee (DMC) and / or Trial Steering Committees (TSC).
• Contributes to keep processes, procedures and systems up to date for recording and processing of serious adverse events.
• Assists with the preparation of audits/inspections and participate in the audit/inspection when appropriate.
• Ensures that all required documents related to reporting adverse events and aggregated reports (SLL, PSUR / PBEBR, Drug SUR, Risk Management planning & reporting, SMP (Safety Management Plans) are managed within AM-Pharma.
• Trains colleagues in the marketing and sales departments, as well as medical and clinical departments on compliance with their reporting responsibilities for Drug Safety
• Starts preparing the organization, systems and infrastructure for the drug safety related requirements associated with the commercialization of the lead product.

What we expect
We expect our Pharmacovigilance Associate to have

• Biomedical Degree (Pharmacy, Medicine, Biology, Chemical Engineering etc.)
• Relevant experience of Pharmacovigilance
• 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

1^st class 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