- Provide accurate, balanced and timely medical and scientific information to internal and external customers such as health care professionals, consumers and other customers
- As a part of the Medical/Legal/Regulatory review and approval process, participate as a medical reviewer for accuracy, content containing promotional and/or medical and scientific content intended for internal and external customers (e.g., communications Q&A material, dear health care provider letters, documents for public comment, etc)
- Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Alkermes colleagues.
- Contribute to departmental/organization efforts to support new product launch preparation and activities
- Support call center operations specific to therapy area and assigned responsibilities
- Independently research and write medical response documents (Standard Response Letters, Medicaid Submission Documents, AMCP Dossier,), create unique responses and proactively update existing response documents on an ongoing basis; obtain approval for use to ensure compliance with existing regulations, policies and procedures; train others (call center, medical affairs, medical science directors) on their content and use
- Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints and are triaged accordingly to PV and QA
- Proactively monitor the literature for new scientific information; identify relevant publications, analyze and communicate information of interest internally Work with internal and external legal counsel to ensure compliance with company policies and procedures
- Provide medical and scientific input and contribute to assigned product and project teams
- Collaborate closely with members of other internal groups (e.g., Regulatory, Marketing, Sales, Legal, Clinical R&D) as needed
- Provide information and support for business activities such as relevant insights, knowledge of product data, etc.
- Attend scientific conferences to provide medical support and to staff medical information booth as assigned
- Lead pre-conference Medical Affairs/Medical Information activities
- Develop post-conference reviews and reports for internal stakeholders
- Assist in the mentorship and training of newly hired staff in Medical Information, Medical Affairs, and other key internal colleagues including but not limited to interns and contractors.
- Domestic and International travel may be required
- Advanced scientific degree preferred (MD, PhD, PharmD, MPH, NP, APRN)
- Other nursing (RN, BSN,) or healthcare related (PA) degrees may be accepted.
- Advanced scientific degree with 2-4 years related experience preferred
- Experience in medical information, medical affairs, and/or clinical development preferred
- Excellent writing skills and the ability to distill complex data into accessible responses
- Experience using Veeva Vault and Sharepoint
- Ability to work in a fast paced environment with competing priorities
- Ability to read, interpret, and convey complex scientific information
- Ability to work independently with minimal supervision
- Excellent written and verbal communication skills
- Excellent customer service skills
- Exceptional interpersonal skills
- Ability to work collaboratively towards a common goal
- Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
- Experience working in a team environment
- Demonstrated results orientation and problem solving skills
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Manager, Medical Information - Watertown, United States - Alkermes
Description
Job DescriptionThe Manager, Medical Information will assist in the operational oversight of Medical Information within the Medical Affairs function. The manager will be responsible for providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers. This role will also be active in the medical content review for promotional and medical materials intended for training and/or external distribution. The manager will monitor the scientific literature and communicate new data to relevant internal groups. Candidates applying for this position must have the ability to take initiative and work independently requiring minimal supervision.
This is a hybrid onsite role based out of our Waltham, MA office.
Responsibilities:
About Us
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
