Main responsibilities:

• Develop and maintain knowledge of specific Nordic regulatory requirements and EU regulatory procedures in general.
• Create and maintain internal and external relationships within the Nordic region, to ensure effective communication and efficient implementation of regulatory activities.
• Assist the work with lifecycle management in the Nordics.
• Review and approve promotional materials for the Nordics.
• Coordinate, review and approve ArtWork.
• Provide support to Senior Manager regarding spontaneous adverse event reports received within the Nordics.
• Ensure that medical information enquiries are responded to in a timely manner and that appropriate responses (written or verbal) are provided.

Required qualifications:

• Life Sciences Graduate, ideally in combination with prior experience in product development functions (pharmaceutical development, clinical trials, etc).
• Regulatory Affairs experience, with good knowledge of regulations and guidelines within the Nordic region.
• Experience in cross-functional project teams.
• Conversant with the primary functions of pharmaceutical development, microbiology, toxicology, clinical research and quality assurance.
• Ideally experience of handling of individual safety reports derived from clinical trials and post marketing arena.

To succeed in this role you should have organisational and planning abilities and be an excellent communicator with the ability to collaborate across cultures and cross-functional.

If this sounds interesting, please apply immediately via an external site (follow this link). Applications will be handled continuously.
For further questions, please contact Sara Tomicic +46 709 731 747 or Jens Mogensen, +46 703 002 002.

ANSVARSOMRÅDEN / ARBETSUPPGIFTER

• Medverka i team vid framtagande av Medical Marketing / Market Access plan
• Ansvara för utvecklande, analys och kommunikation av medicinska data både för nya produkter och för marknadsförda nyckelprodukter
• Medverka i utvärderingen av in-licensieringsmöjligheter genom medicinska och marknadsmässiga analyser
• Kommunicera studieresultat till intern och extern publik
• Utbilda olika delar av Nycomed Sveriges organisation om produkter
• Träffa kunder tillsammans med andra medarbetare inom Nycomed
• Bygga upp/upprätthålla ett externt nätverk av samarbetspartners och konsulter
• Aktivt medverka till att bilda och driva Advisory Boards med representativa företrädare för professionen

KONTAKTER

• Kunder och relevanta stakeholders inom hälso och sjukvården
• Andra läkemedelsföretag
• Branschorganisationer
• Relevanta befattningshavare inom Nycomed och Takedakoncernen
• Andra kontakter beroende på projektets art. (ex. LV, SoS, TLV, etc.)

KOMPETENSPROFIL

• Akademisk profil
• Leg. läk.
• Doktorsexamen är meriterande men inget krav
• Specialistkompetens kan vara en fördel
• Flytande engelska i både tal och skrift är väsentlig

Personlig profil

• Självständig, engagerad, initiativrik och stark i genomförandefas
• God samarbets- och kommunikationsförmåga, inklusive styrka i muntlig presentation
• Aktiv i nätverk
• Lagspelare
• Strukturerad

För mer information vänligen kontakta Jens Mogensen, Scientific Solutions, på mobil: 0703 002 002 alt. jens@scientificsolutions.se

Startdatum är förhandlingsbart och utvärdering av kandidater görs löpande.
Välkommen med din ansökan!

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Nordic Regulatory Affairs Assistant at Actavis, you are responsible for assisting the regulatory team with administrative tasks.
The position is placed at the Nordic office, Kungsholmen Stockholm.

Main responsibilities:

• Archiving of regulatory documents electronically as well as in paper copies.
• Updating of various databases, e.g. Fass, Felleskatalogen, DKMAnet etc.
• Proof reading of regulatory texts and artwork.
• Assist the regulatory staff with artwork creation.
• Participate in regulatory team meetings.

Required Qualifications:

• Previous experience from administration in the pharmaceutical industry.
• Experience from work in a Regulatory team, preferably in a Nordic organization.
• Strong skills in English and preferably in at least one Nordic language.

Desirable personal characteristics:

• Strong organizational skills.
• Positive and curious.
• Ability to handle several tasks simultaneously.

To succeed in this role you should appreciate administrative and coordinating tasks. Furthermore, you must be effective and enterprising, and have the ability to handle stressful situations. You should also have the ability to create and maintain good relationships with your colleagues, and take great responsibility for your own work.

You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than May 25th.
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Quality and Pharmacovigilance Coordinator at Actavis, you are responsible for administrative tasks relating to the management of adverse event reports and complaints.
The position is placed at the Nordic office, Kungsholmen Stockholm.

Main responsibilities:

• Receiving and handling of adverse events, including reconciliation lists.
• Communicate with Corporate Product Drug Safety.
• Communicate with Medical Information service providers.
• Receiving and handling of complaints.
• Communicate with Pharmacies and customers.
• Communicate with supply chain and local distributors.

Required Qualifications:

• Higher education, preferably degree in Nursing or Pharmacy.
• Previous experience from administration in the pharmaceutical industry.
• Experience from customer services.
• International experience.
• Strong skills in English and preferably in at least one Nordic language.

Desirable personal characteristics:

• Strong organizational skills.
• Positive and a service-minded approach.
• Ability to handle several tasks simultaneously.

To succeed in this role you should appreciate administrative and coordinating tasks. Furthermore, you should enjoy the contact with customers, be a very good communicator and have the ability to create and maintain good relationships with colleagues, distributors and customers. You should also take great responsibility for your own work.

You apply for this position via an external application site (follow this link) with your CV and a short personal letter.
Apply as soon as possible, no later than May 25th.
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Nordic Regulatory Affairs Manager at Actavis, you will be responsible for managing Regulatory Affairs Projects in the Region. You will coordinate and support the regulatory activities for the product portfolio you are responsible for.
The position is placed at the Nordic office, Kungsholmen Stockholm.

Main responsibilities:

• Preparation, submission and follow up of national applications for new marketing authorizations.
• Proof reading of regulatory texts.
• Submission of Life Cycle Management changes (variations, renewals, line extensions).
• Responsible for changes in artwork, i.e. requesting, proof reading and approval of artwork.
• Submission of national notifications and applications, such as permission for dose dispensing and OTC-switches.
• Responsible for local knowledge of applicable legislation within the responsibility area.
• Communication with local Drug Regulatory Authorities.
• Coordination with other functions such as logistics, sales, marketing and launch, regarding the regulatory work.
• Coordinate the update of various local databases in the Nordic countries, e.g. FASS, NPL, DKMAnet, Felleskatalogen.

Required Qualifications:

• Higher education – preferably degree in Pharmacy, Medicine or equivalent.
• Substantial experience in a Regulatory Affairs team with very good knowledge of Nordics local legislation and guidelines.
• Good understanding of market dynamics and requirements in the Nordic region.
• Experience from an international work environment.
• Excellent skills in the English language and preferably in at least one Nordic language.

Desirable personal characteristics:

• Thorough, structured and strong organisational skills.
• Excellent team player with the ability to establish and maintain effective working team relationships.
• Have a positive and service-minded approach.

To succeed in this role you must be effective and have the ability to work independently, handle stressful situations and handle several tasks simultaneous. Furthermore you should have excellent communication skills, enjoy teamwork and be passionate about Regulatory Affairs.

You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than May 25th .
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Nordic Artwork coordinator at Actavis, you will work with Nordic artwork in the Actavis Artwork Database Portal. You will be responsible for requesting artwork for new products and product transfers, and will act as a contact person for communication with the Actavis Group Artwork Studio.
The position is placed at the Nordic office, Kungsholmen Stockholm.

Main responsibilities:

• Continuously maintain local knowledge of applicable legislation within the responsibility area, and to inform local and corporate persons, when necessary.
• Request of new artwork in Actavis Artwork Database Portal.
• Technical proofreading of artwork.
• Request of changes in existing artwork when technical changes.
• Communicate with the Regulatory team to support with expertise to questions regarding artwork.
• Communicate and coordinate the artwork with the Actavis Group Artwork Studios.
• Participate in the Nordic Launch and Transfer team.

Required Qualifications:

• Substantial experience working with artwork within the pharmaceutical industry.
• Experience from working in a Regulatory team in an international work environment.
• Extensive knowledge in relevant legislation and guidelines, within the area of responsibility.
• Good understanding of market dynamics and requirements in the Nordic region.
• Strong skills in English and preferably in at least one Nordic language.

Desirable personal characteristics:

• Thorough, structured and strong organizational skills.
• Service-minded approach and an excellent collaborator.
• Ability to handle several tasks simultaneously.

To succeed in this role you must have excellent communication skills and be able to establish and maintain effective working team relationships with supporting teams. Furthermore you should be able to lead projects within tight time frames and be passionate about artwork.

You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than May 25th.
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Nordic Regulatory Affairs Manager, Team Leader at Actavis, you will be managing your team and be overall responsible for regulatory activities in connection to submissions of new products and Life Cycle Management for approved products. The position is placed at Pharmaceutical Affairs at the Nordic office at Kungsholmen, Stockholm.

Main responsibilities:

• Manage your team and oversee that the product portfolios are well balanced and the workload is spread evenly among the regulatory staff.
• Respond to general queries addressed to the Nordic regulatory office.
• Maintain a system for filing to ensure the availability of accurate information for the product portfolio.
• Manage regulatory activities in the Nordic countries, e.g.;

  o Preparation, submission and follow up of national applications for new marketing approvals.
  o Proof reading of regulatory texts.
  o Changes in Art Work.
  o Submission of national notifications and applications.

• Act as the Nordic contact person and communicate with local Drug Regulatory Authorities.
• Continuously maintain local knowledge of applicable legislation within the responsibility area and to inform local and corporate persons, when necessary.
• Responsible for regulatory coordination with other functions such as logistics, sales, marketing and launch when needed.

Required Qualifications:

• Higher education – preferably degree in Pharmacy, Medicine or equivalent.
• Substantial experience in a Regulatory Affairs team with very good knowledge of Nordics local legislation and guidelines.
• Good understanding of market dynamics and requirements in the Nordic region.
• Experience from an international work environment.
• Excellent skills in the English language and preferably in at least one Nordic language.

Desirable personal characteristics:
To succeed in this role, you should have strong organizational skills with the ability to lead projects within tight time frames. Furthermore, you should have strong leadership abilities, excellent communication and enterprising skills and be able to establish and maintain effective working team relationships.

You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than May 31st .
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

During 2012, Actavis will form a Nordic organization with a new head office in Stockholm, Sweden and need to recruit several professionals to newly created positions. For recruitment to positions within Pharmaceutical Affairs will Actavis collaborate with Scientific Solutions.

As a Nordic Pharmacovigilance & Medical Information Manager at Actavis, you will be responsible for coordination of Pharmacovigilance and Medical Information in the Nordic countries and to report requests and information related to pharmacovigilance/drug safety/risk-benefit to the global Pharmacovigilance and Drug Safety function (PDS Europe/RoW). You will also act as manager for one employee.
The position is placed at the Nordic office at Kungsholmen, Stockholm.

Main responsibilities:

• Managing adverse event reports and forward locally received reports to the PDS Europe/RoW within set time limits.
• Continuously maintain local knowledge of applicable Legislation within the responsibility area.
• Act as the Nordic contact person for questions related to pharmacovigilance and Medical Information, and communicate with Nordic authorities.
• Training of employees locally in pharmacovigilance.
• Responsible for Safety Data Exchange Agreements (SDEA) and pharmacovigilance clauses in agreements with Service Providers/Pharmacy chains and other third parties.
• Managing the local licenses, together with the regulatory staff, in case of safety variations.
• Deputy for Review and approval of Promotional materials and Quality issues.

Required Qualifications:

• Higher education – preferably degree in Pharmacy, Medicine or equivalent.
• Extensive experience from Drug Safety with very good knowledge of Nordics local legislation in the field of Pharmacovigilance.
• Excellent skills in the English language and preferably in at least one Nordic language.

Desirable personal characteristics:

• Thorough, structured and have strong organisational skills
• Service-minded approach
• Ability to handle several tasks simultaneously

To succeed in this role you must have excellent communication skills, ability to pursue issues and to structure your own work. Furthermore should you also have excellent leadership abilities and be passionate about pharmacovigilance.

You apply for this position via an external application site (follow this link), with your CV and a short personal letter.
Apply as soon as possible, no later than May 13th.
For further questions, please contact Sara Tomicic, recruitment consultant at Scientific Solutions, +46 709 73 17 47.

Actavis är ett av världens ledande företag inom utveckling, tillverkning och försäljning av generiska läkemedel. I Sverige marknadsför Actavis över 200 produkter inom tre affärsområden: Öppenvård, Slutenvård och Egenvård.

Actavis står idag inför en omorganisation som omfattar delar av verksamheten i Sverige, Danmark, Norge, Finland och Island. Ett nordiskt kontor, med ansvar för supportfunktionerna, kommer att öppnas i Stockholm under sommaren 2012. I samband med att den nordiska organisationen skapas, är Actavis i behov av att rekrytera in kompetens till ett flertal nyinrättade tjänster inom Pharmaceutical Affairs på det nordiska kontoret i Stockholm.

Scientific Solutions har fått i uppdrag är att rekrytera personer till dessa tjänster och kommer under den närmaste tiden att söka naturvetare med kortare och längre erfarenhet inom Regulatory Affairs, Drug Safety och Medical Information. Specifika annonser för de olika tjänsterna kommer att presenteras här på hemsidan, så håll gärna utkik!

Vi på Scientific Solutions ser fram emot samarbetet med både kandidater och Actavis!

Just nu söker vi kandidater för uppdrag som Drug Safety Officer, hos en av våra kunder i Stockholm.

I denna roll kommer Du att ha ansvar för insamling och processande av biverkningsrapporter, arbeta med SOPar, samt svara på frågor kring företagets produkter. Du kommer att arbeta i team och ha många, både interna och externa kontakter i ditt dagliga arbete.

Vi tror att Du är farmaceut eller har liknande utbildningsbakgrund och att Du har viss erfarenhet av arbetsuppgifter inom pharmacovigilance och/eller medical information, antingen från läkemedelsindustri eller från myndighet.

För att lyckas i rollen som Drug Safety Officer, krävs att Du har god servicekänsla och är flexibel i ditt arbetssätt. Andra egenskaper som uppskattas är noggrannhet, organisationsförmåga och att Du tar stort eget ansvar för dina arbetsuppgifter. Utmärkt förmåga att uttrycka Dig i tal och skrift på svenska och engelska är ett krav.

Tycker Du att ovanstående beskrivning passar in på Dig, så sänd omgående in Din ansökan via extern ansökningssida (följ denna länk).
Frågor besvaras gärna av Sara Tomicic på telefonnummer 0709-731747.

Varmt välkommen in med Din ansökan!