Medical Affairs Specialist

About the position
We are now looking for a consultant who is ready for a challenging assignment within Medical Affairs at a global, expanding company within pharmaceutical.
The Medical Affairs team of the client advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of their products is realized. The company engage and train employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate their portfolio.

Your profile
Qualifications:
The position requires either a Medical Degree or a Pharmacist Degree or equivalent (MSc) in Life Science. Relevant prior experience can replace the above mentioned preferred educational requirements.
– Pharma Industry Experience >2 years. Knowledge of the Swedish ethical code and experience of either creating or approving promotional materials within the pharma industry.
– IMA certification
– Swedish and English language: fluent verbal and written

Responsibilities:
Primary activities MEDICAL REVIEW.
Providing adequate and timely review of local promotional material to ensure it is medically accurate, balanced and in accordance with local regulations, MSD promotional standards and Medical Review SOP, as well as other applicable rules, regulations and standards.
As applicable providing training to business colleagues in topics related to standards of promotional materials, local code and regulations. Participate in the collaborative effort to responding to complaints from competitors and/or National Regulatory authorities and similar.
Providing regular updates of relevant statistics and insights relating to the review of promotional materials to the medical affairs management and commercial organization.
Staying abreast of internal and external changes to the environment affecting Medical Review and promotional activities and ensuring these changes are addressed in a timely and appropriate manner.
Providing high-quality timely responses to escalated questions (from external Designated Point of Contact, DPOC) about MSD products in a fair and balanced accurate format in accordance with local standards and procedures.
Creating and maintaining local medical (and other) standard responses as needed.
Documenting details of inquiries described above and corresponding responses in the inquiry database. Within 24 h, report any adverse events and/or product complaints to relevant function, and with same timeframes update already reported cases with any new information.
Leading local DPOC-meetings (DPOC= designated point of contact) with relevant stakeholders to share information, align processes and to develop and improve current practice. Local implementation of Medical Information Request (MIR) standards and process with the local Medical Affairs department as well as appropriate training of marketing and sales organization.
Staying abreast of new medical and product developments in relevant areas.
Providing regular updates of relevant statistics and insights in Medical Information related topics to the Medical Council as well as commercial organization.

If you want to know more about this opportunity please contact Irma Leijon at Irma.Leijon@poolia.se.
Look forward reading your application!