Associate / Director Medical Affairs / Information
January 1, 2018
Full Time - Experienced
This Medical Affairs Associate Director will work as head of the Medical Information team, overseeing provision of up-to-date, accurate and balanced information on products to internal and external customers. This role will a require an experienced Medical Information professional to undertake a key role in the Global Medical Affairs group to support both licensed and developmental products at this exciting time of growth for the company.
Provide a high quality Medical Information service to both internal and external customers, record comprehensive details to the Global Enquiry Management System and operate in line with local SOPs, Copyright Law, DIA, OIG and FDA guidelines.
Prioritize, plan and organize work considering the customer and business needs regarding creation and day to day management of a medical information call center.
Collaborate with PV & Quality to ensure efficient adverse event and quality reporting, in compliance with Medical Affairs, PV and Quality department guidelines.
Identify enquiry trends and emerging issues and raising awareness with appropriate colleagues as well as providing input to business tenders where appropriate.
Ensure that product knowledge and search system skills are gained, applied and maintained and assist in developing and maintaining standard responses and procedures.
Enhancing Standard Response Content quality using multimedia
Working with the MSL team to raise awareness of the Medical Information operation and processes with the broader Global teams.
Provide training and guidance to junior members of the Medical Information team, as well as day to day management.
The Senior Medical Information Scientist is responsible for maintaining cGxP and H&S knowledge applicable to the job and carries out their work in a way that will not adversely affect their own, or others’, health, safety and security or the environment and reports any shortcomings in GW arrangements.
Work with the Medical Affairs Director to review, improve and develop the Medical Information Department to meet changing business needs
Liaises with colleagues in the United Kingdom to ensure uniformity of information delivery
Project work to support the activities of the Global Medical Affairs group from time to time
Generate standard and custom response materials.
Complete email and telephone enquiry logs
Respond to telephone calls and emails in a professional manner and ensures that medical enquiries are answered within the specified timelines
BS/MS degree in Life Sciences, Pharmacy or related field; advanced degree preferred
3+ years of Medical information pharmaceutical/device management; 5+ years of experience preferred
Neurology or Epilepsy experience, and rare disease experience preferred
Competency with scientific/medical terminology
Ability to quickly learn new software and contribute to design.
Report writing experience
Experience with content management systems such Veeva and IRMS
Knowledge of medical information systems; expertise in medical information best practice preferred.
Knowledge of US pharmacovigilance and regulatory requirements.
Excellent digital proficiencies and high learning capacity for software.
DIA certification in Medical Communications
AMCP dossier experience
Experience launching a new product and developing a medical information plan
Proficiency with MS Office.
Impeccable attention to detail, paired with an action-based orientation and innovative approach.
Positive collaborative attitude
Strong and fluent communication skills, including ability to converse on lay-person level with compassion
Ability to work within a commercially-focused, fast-moving and delivery-orientated environment.
Greenwich Biosciences, Inc. vision is to make a positive difference in the lives of patients through the development of a portfolio of cannabinoid prescription medicines in a wide range of therapeutic indications. Our strategy is to build on our world leading position in the field of cannabinoid science and in the research, development and commercialization of cannabinoid molecules as novel prescr...iption pharmaceutical therapeutic candidates. Epidiolex is Greenwich’s lead cannabinoid product candidate and is a proprietary oral solution of pure plant-derived cannabidiol, or CBD. Greenwich’s Epidiolex development is initially concentrating on severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).
We have made a commitment to establish a fully integrated US operation to commercialize the product, with our US headquarters in Carlsbad, CA. Our Parent company (GW Pharmaceuticals, PLC), was founded in 1998 and is based in the UK.
We are continuing to build out our team and are looking for talented individuals dedicated to making a difference in the lives of our patients.