Medical Services Specialist
Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier every day. But what really makes it work at Organon is our people.
We’re looking for real, passionate team players, curious innovators, forward thinkers, empowered by the idea of shaping their career, and ready to bring their fire to embrace change and the opportunities it brings for progress.
At Organon, you’ll get to enjoy the best of both worlds: the open, agile, collaborative culture of a start-up, and operating at the scale of a Fortune 500 company with an international footprint that serves people in more than 140 markets.
It’s going to be an exciting future—come be a part of it!
About this opportunity :
You will manage processes relating to promotional and medical review, ensuring the highest standards in medical communications are achieved. Responding to complex medical inquiries, escalated to you via the external Designated Point of Contact (DPOC) vendor, you will also provide support, oversight and guidance to them in their operations, as Organons’s first point of contact for healthcare professionals and other external stakeholders requesting information or reporting adverse events etc.
With three primary areas of focus (Medical Review, Medical Information & DPOC (Designated Point of Contact) Process Management) you will be accountable for the following business activities :
Managing processes related to promotional/training and educational material review and approval (i.e. review flows, priorities, outsourcing, metrics, SOP, implementation of regional initiatives)
Operating as an expert, providing advice in relation to regulations and laws governing promotional materials in ANZ
Contributing to cross functional teams and brand development by proactively demonstrating and sharing your deep understanding of therapeutic areas, products and competitors
Providing technical, scientific and ethical advice to all business partners as required, using interactions with stakeholders to further develop their knowledge
Ensuring medical review of material is completed with accuracy, in a timely manner with a solutions focus, meeting ANZ policy and regulations prior to public release
Collaborating with colleagues to improve processes, ensuring consistency in procedures/practices, particularly across therapeutic areas
Supporting the provision of training to ANZ staff relating to SOPs, policies, guidelines as well as local laws and regulations
Assessing and responding to unsolicited on and off label complex inquiries received from healthcare providers and other stakeholders
Ensuring responses to medical inquiries are high-quality professional communications, aligned to local and global standards and requirements.
Ensuring written responses are comprehensive, balanced, relevant, clear and completed within target timelines
Establishing standard answers for FAQ's for the external DPOC vendor in collaboration with Medical Advisors and Medical Science Liaisons
Researching, assessing and compiling responses from published and unpublished literature to create clinical support in a fair, balanced, and scientifically accurate format
Identifying gaps within the medical information process as well as providing rapid resolution
DPOC (Designated Point of Contact) Process Management
Providing support to the external DPOC vendor, including training and upskilling of new agents, to ensure agents are able to ensure receipt, classification and appropriate routing of product inquiries
Supporting and training Medical Advisors/Medical Science Liaison and other staff in the management of DPOC/medical information requests
Supporting DPOC agents when required, ensuring adverse events and product quality complaints are reported to the appropriate departments in accordance with standard operating procedures and timelines
Required Experience :
Demonstrated successful track record in a medical review role
High level of scientific and ethical integrity
Deep understanding of ANZ requirements relating to promotional/training medical communications material including Medicines Australia Code of Conduct and other relevant local laws and regulations
Strong problem solving, planning, organisation and negotiation skills
Proven ability to engage and collaborate with stakeholders, communicating with influence
Proven ability to assimilate and communicate scientific information in a simple, concise manner
Advanced written communication skills, able to communicate key messages to multiple audiences
Education Required :
PhD, B Pharm or other relevant life sciences degree
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:1