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Manager, Global Medical Information (Contract)

Remote:

Full Remote

Contract:

Full time

Experience:

Entry-level / graduate

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Post graduate degree in medical field, 2+ years experience in Medical Information/Communications.

Key responsabilities:

Manage global medical information systems and response documents
Ensure provision of quality response documents adhering to guidelines
Coordinate field medical outreach, maintain reporting metrics
Contribute to Medical Information Center of Excellence work

Amicus Therapeutics

501 - 1000 Employees

See more Amicus Therapeutics offers

Job description

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing, and delivering high-quality medicines for people living with rare metabolic diseases.

Position Summary

The Manager, Global Medical Information (GMI), Global Medical Affairs (GMA) will assist in supporting medical information services in all countries or regions of the world where Amicus Therapeutics markets and distributes medications. This support will include the management of global and / or regional contract call center vendors working in close alignment with clinical, medical, safety, and the product quality teams, and assist in the development of high-quality inquiry response documents.

Roles And Responsibilities

Assist in the management of global medical information systems, and the development and renewal of compliant standard response documents (SRDs), FAQs, and custom (escalated) responses to inquiries from domestic and country affiliates, with documents tailored to individual countries using clinical studies and reference papers, in collaboration with in-house subject matter experts.
Assist in ensuring the provision of quality response documents that are scientifically balanced and evidence-based, adhering to topic / key messages, and exhibiting proper language and grammar, with regulatory / safety / legal aspects considered.
Upload updated MI content/materials/SRDs into the Veeva MedComms system and ensure proper citations and content is annotated correctly in addition to addressing feedback from the reviewers in a timely manner. Attend and participate in Copy Review Board (CRB) meetings as needed.
Assist in ensuring that quality, timeliness, and benchmark metrics are met, and to coordinate field medical outreach along with external vendors/distributors and follow up documentation, as necessary.
Organize monthly reporting metrics for Medical Information and maintain relevant documents in the SharePoint folder and MI Resource Library.
Respond to global and US medical inquiries appropriately and in accordance with the GMI process.
Assist with monthly MI call center audits and ensure all requirements are met.
Contribute to the work of the Medical Information Center of Excellence as a member.

Requirements

Educational Requirements

Post graduate qualification in medical/scientific field (e.g., PharmD, MPharm or equivalent)

Professional Work Experience Requirements

2+ years experience in Medical Information / Communications in the pharmaceutical or related industry.
Experience with rare diseases, preferred
Medical information call center experience, preferred.

Experience And Skills

Excellent English communication skills both written and spoken; secondary language desirable
Strong knowledge and application of good practices in medical writing and regulatory requirements
Experience with evaluating and reviewing medical / clinical content and providing constructive feedback.

Other Skills/Attributes

Demonstrated alignment with Amicus Mission Focus Behaviors
Passion for rare disease and patient focused
Good team player

Location and Travel

Remoted based
Available during United States Eastern time zone business hours
Travel less than 5%

We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all. Our unique experiences, backgrounds and range of cultural perspectives enrich how we approach opportunities, pushing ideas as far and as fast as possible with patients always our top priority. Employee expertise, intelligence, and creativity drives our innovation, and our passion and commitment to excellence. Our “Three Pillars of DEI” are interwoven into our Amicus culture and expands one person, one word, and one act at a time. For our employees, these three pillars are a touchstone for inspiration, guidance, and encouragement.

Amicus is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability, sexual orientation, gender identity, protected veteran, disability status or any other characteristics protected by applicable federal, state or local law.