Manager, Medical Information

4 weeks ago

Waltham, Massachusetts, United States Alkermes, Inc. Full time

The 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:

  • 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

Basic Requirements:

  • Advanced scientific degree preferred (MD, PhD, PharmD, MPH, NP, APRN)
  • Other nursing (RN, BSN,) or healthcare related (PA) degrees may be accepted.

Preferred Requirements:

  • 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

#LI-HB1

PDN-9bdf6f65-c6b7-4d6a-b220-edb3da09a828

  • Senior Director, Regulatory Information Management

    1 week ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Executive Director, Medical Director

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Senior Program Manager

    1 month ago

    Waltham, Massachusetts, United States Boston Engineering Full time

    Company DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. We are product designers and engineers for the Medical, Industrial, Commercial, and Defense sectors. Experts in robotics, motion control and embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485...

  • Practice Manager- Waltham

    1 month ago

    Waltham, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    SCOPE OF POSITIONReceiving general direction from the Administrative Director and the Associate Chief of Pediatric Primary Care. This role holds first-line responsibility for the supervision of the clinical administrative team (6 FTEs currently) which includes oversight of the development of policies and procedures, data tracking and reporting, and back-up...

  • Assistant General Manager

    2 days ago

    Waltham, Massachusetts, United States Hyatt House BostonWaltham Full time

    ABOUT USAt Waterford Hotel Group we pride ourselves on cultivating a workplace that feels like home and brings out the best in you, each and every day. We celebrate your successes, your strengths will be appreciated, and a place where each of us can truly be ourselves. We offer competitive compensation and benefits, a tight-knit and supportive work...

  • Manager/Senior Manager, CMC Regulatory Affairs

    4 weeks ago

    Waltham, Massachusetts, United States Alkermes, Inc. Full time

    Great Science.Deep Compassion.Real Impact.Alkermes is offering exciting opportunities through our commitment to work together to help improve the lives of people living with serious mental illness, and addiction.We are inspired by the courage and determination of individuals living with complicated and often difficult-to-treat diseases. We have a portfolio...

  • Tax Manager, Planning and Transactions

    1 month ago

    Waltham, Massachusetts, United States REVVITY Full time

    Job TitleTax Manager, Planning and Transactions (REMOTE)Location(s)US Remote - CT, US Remote - DC, US Remote - FL, US Remote - IL, US Remote - MA, US Remote - MN, US Remote - NC, US Remote - NH, US Remote - OH, US Remote - PA, US Remote - RI, US Remote - SC, US Remote - TN, US Remote - TX, US Remote - VA, US Remote - VT, WalthamAbout UsRevvity is a developer...

  • Project Manager, Gas Capital Project Delivery

    4 days ago

    Waltham, Massachusetts, United States National Grid Full time

    About usNational Grid is hiring a Project Manager for our Gas Complex Project Management department in Waltham, MA. This is a hybrid role, with approximately 1-2 days in the office or at the job site weekly.Every day we deliver safe and secure energy to homes, communities, and businesses. We are there when people need us the most. We connect people to the...

  • Manager, Quality Assurance Operations

    4 weeks ago

    Waltham, Massachusetts, United States Elevatebio Full time

    ElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential.The Role:ElevateBio...

  • Senior Technical Program Manager

    2 days ago

    Waltham, Massachusetts, United States Markforged Full time

    Markforged (NYSE: MKFG) is reinventing the $1 trillion+ worldwide manufacturing industry so that engineers can build anything they imagine while reducing environmental impact. With the market's most robust 3D printing hardware, software and material solution, a world-class team, great customers and abundant capital, we're well placed to continue our growth...

  • Senior Manager, Supply Chain

    2 days ago

    Waltham, Massachusetts, United States Markforged Full time

    Markforged (NYSE: MKFG) is reinventing the $1 trillion+ worldwide manufacturing industry so that engineers can build anything they imagine while reducing environmental impact. With the market's most robust 3D printing hardware, software and material solution, a world-class team, great customers and abundant capital, we're well placed to continue our growth...

  • Patient Services Coord. III

    3 weeks ago

    Waltham, Massachusetts, United States Massachusetts General Hospital Full time

    PRIMARY CARE ASSOCIATES (PCA) - MGH WALTHAM GENERAL SUMMARY/ OVERVIEW STATEMENT: The Patient Services Coordinator III, under supervision of the Practice Manager, provides administrative support to health care providers in a high-volume ambulatory setting, functioning as the primary interface between the care team and the patients. The emphasis is placed on...

  • Strategic Relationship Manager, Venture Acceleration

    2 weeks ago

    Waltham, Massachusetts, United States National Grid Full time

    About usNational Grid Partners is hiring a Strategic Relationship Manager, Venture Acceleration. This is a hybrid role that can be based out of our California, Brooklyn, NY, or Waltham, MA offices. National Grid Partners launched in 2018 as the corporate venture and innovation arm of National Grid, one of the world's largest investor-owned utilities. Since...

  • Senior Director, Drug Safety and Pharmacovigilance

    4 weeks ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....

  • Desktop Support Tech Lead

    2 weeks ago

    Waltham, Massachusetts, United States Cognizant Technology Solutions Full time

    Cognizant is seeking a End User/ Desktop Support Tech for a full-time opportunity in Waltham, MABenefits: Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:Medical/Dental/Vision/Life InsurancePaid holidays plus Paid Time Off401(k) plan and contributionsLong-term/Short-term DisabilityPaid Parental...

  • Senior Mechanical Engineer

    4 weeks ago

    Waltham, Massachusetts, United States Boston Engineering Full time

    Company DescriptionBoston Engineering improves the way people work and live through innovative product design and novel engineering. Our teams of product designers and engineers for the Medical, Commercial, and Defense sectors. Experts in robotics, control systems, embedded systems, DFX, and digital transformation, we are ISO 9001 and ISO 13485 certified....

  • Director, Clinical Research and Early Programmes Immunology

    2 weeks ago

    Waltham, Massachusetts, United States GlaxoSmithKline Full time

    Site Name: UK - Hertfordshire - Stevenage, Belgium-Wavre, UK - London - Brentford, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Upper Providence Posted Date: May 3 2024 A Director, Clinical Research and Early Programmes Immunology is sought to provide clinical and scientific insights to the immunology franchise including...

  • Sr. Division Coordinator

    2 days ago

    Waltham, Massachusetts, United States Brandeis University Full time

    Brandeis University is delighted to announce a career opportunity of Senior Division Coordinator, Division of Science. If you are looking for an opportunity to work at a beautiful university campus with lots of perks including free parking, look no further. At Brandeis we offer a competitive benefits and compensation package which includes medical, dental...

  • Assistant Director of Admissions for Access and Outreach

    2 days ago

    Waltham, Massachusetts, United States Brandeis University Full time

    Assistant Director of Admissions for Access and OutreachlocationsBrandeis - Waltham Campustime typeFull timejob requisition idR0009958Brandeis University Undergraduate Admissions is accepting applications for the position of Assistant Director. This person will promote the University through both on and off campus recruitment programs, which include public...

  • Director, Clinical Quality Assurance

    1 month ago

    Waltham, Massachusetts, United States Dyne Therapeutics Full time

    Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue....