Associate Director

Description:

The Associated Director of International Medical Review and Medical Information is responsible for supporting above country, International level medical review as part of the Medical, Legal, Regulatory (MLR) Review Committee and perform Medical Information activities pertinent to the International region. Service functions within assigned therapeutic area(s) (TAs), including but not limited to the medical review of promotional and non-promotional scientific materials, and implementation of medical information deliverables within set timelines via cross-functional collaboration. This role is responsible for developing and maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease areas, ensuring high quality standards are applied for end deliverables to fulfil internal and external regulations.

As necessary, this individual may support broader activities in the department of Global Medical Communications. This may include development of scientific content, training materials, presentations and other documents, and participation in other activities (e.g. congresses).

The employee carries out this role in accordance with departmental SOPs, corporate policies and other legal and regulatory requirements.

You will be responsible for:

Medical Review support may include but is not limited to:

Representing medical function in the MLR Review Committee and ensuring scientific / medical / clinical accuracy, relevance and completeness of data, appropriateness of references cited and that promotional claims within materials are adequately supported by data.
This would require developing and maintaining current, broad, and in-depth knowledge of pathophysiology, diagnosis, drug therapy, standards of care, competitive landscape, desired patient outcomes, and clinical outcomes associated with assigned Alexion products and disease states.
Providing medical / scientific expertise to cross-functional stakeholders (e.g. commercial, medical, patient experience etc. teams) for appropriate disease and product material development.
Collaborating with Medical Affairs Directors/Team leads to ensure promotional and non-promotional materials are aligned to medical strategy
Collaborate with the other reviewers, process coordinator, and project owners to ensure appropriate support and timely reviews
Ideally, familiarity with the ABPI code of practice
Medical Information support may include but is not limited to:

Understanding and effectively applying/complying with appropriate ethical, legal and regulatory standards, including those for responding to unsolicited requests for information, on / off label inquiries, and product promotion.
Serving as the scientific expert in the given therapeutic area(s) (TA) and as the escalation point for triage of complex inquiries from the contact center;
Help with inquiries requiring escalation or customization; maintaining up-to-date medical information and knowledge management systems / repositories, as appropriate
Ensures compliance with workflow procedures and standards
Participating in medical information booth activities both during preparation for and during professional scientific meetings / medical congresses.
This may include staffing the medical information booth and responding/documenting HCP inquiries , ensuring medical information resources are in-date, cross-functional colleagues are trained and post-congress reports are completed within a timely manner.
Collection and analysis of area metrics and analytics; maintains in-depth understanding of historic trends and insights of inquiries received.
Contributes to developing a strategy and tactical execution of development / maintenance and review / approval for global medical information response documents, where required.
Proactively distributing important product and/or medical information to relevant internal Medical Affairs functions as necessary in support of product changes, safety issues and other sentinel events; enhances medical and product knowledge within the Sales Force, Marketing, Field Medical and other departments by disseminating relevant information on a consistent basis, as needed.
Systematically compiling / assessing / maintaining / communicating metrics that monitor Medical Information trends. Has a detailed and in-depth understanding of historic trends and insights and is able to apply these analytics to the medical plan.
Other responsibilities include but may be not limited to:

Supporting various operational initiatives including development and maintenance of SOPs/guidance documents; training modules; database/system enhancements; vendor oversight; obtaining relevant metrics etc.
Achieving and maintaining compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Alexion are carried out with the best industry practices and the highest ethical standards. Advocate for these to other internal and external stakeholders
As applicable, providing support to broader activities in Medical Communications, including Medical Education and Scientific Communication
Identifying potential opportunities for process and system improvement pertinent to the MLR review and Medical Information tasks, and proposing solutions for and overseeing implementation of improvements

You will need to have:

Advanced scientific degree in pharmacy (PharmD) or related science (PhD, MD) with minimum 3 years medical review, medical information, medical affairs or relevant experience in the pharmaceutical / biotech industry and/or medical communications with relevant responsibilities
1-2 years of relevant experience in reviewing and approving promotional and/or non-promotional materials
Proven record of medical review support, and experience with the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts
Experience with/understanding of drug development life cycle, health authority regulations and reporting requirements
Proficient in collaboration, negotiating and influencing skills
Excellent written and verbal communication skills
Highly proficient in literature searching and medical writing skills
Highly detail-oriented in review of diverse materials, and in the development of medical information and other documents
Self-motivated to drive for results, with strong organizational and planning skills
Highly proficient with Microsoft Office Suite
Ability to travel to meetings / conferences (domestic and international) approximately 10% of the time
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.