Company Description:Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.
Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.
Recognitions:
Summary: At local level, the Medical Information Officer is responsible for the observance of § 8 Abs. 1 Nr. 2 AMG as well as local MRC/CRC activities such as the coordination of local reviews of internal and external material, the final approval for local CRC/MRC. At EMEA level, she/he will be responsible for medical information activities such as managing the approval workflow of medical information response letters or handling escalated inquiries from HCPs or members of the public Responsibilities: §74a AMG Germany:

• Responsibility for observance of § 8 Abs. 1 Nr. 2 AMG, including
• Support of creation and updates of Sm PCs, labeling, package insert
• Mandatory text by § 4 HWG,
• Listings (Rote-/Gelbe Liste),
• Continuously screening of changes in national relevant laws and ensuring compliance with the Insmed compliance requirements
• Ensure no misleading information are observed in the advertising of Insmed medicinal products
• Ensure that advertising comply with the marketing authorization of the medicinal product

CRC – MRC:

• Coordinates local reviews of internal and external medical-, promotional- and non-promotional content/material (CRC/MRC) in collaboration with Commercial (Marketing Lead), Compliance, Medical (Medical Advisors) and Regulatory (EUDRAC) reviewers
• Responsible for local implementation of EMEA CRC/MRC reviewed material. (Check of translation in German language)
• Final approver for local Commercial and Medical Reviews (dependent on business decision, alternatively Medical Lead DACH)

Medical Information:

• Responsible for the translation and approval of medical information standard response letters for the EMEA Region
• Creates standard and customized response letters and FAQs containing information available from reliable sources, including published medical literature, recently conducted clinical trials and data analyses, changes in product labeling, and from recent changes in EU regulations
• Ensures that responses to unsolicited medical inquiries and requests for medical information from healthcare professionals are in keeping with Insmed’s Medical Information Standard Operating Procedures and in-line with EU Regulatory Authority regulations
• Respond to escalated medical inquiries from healthcare professionals or member of the public

Compliance:

• Ensuring training and adherence to compliance

Collaboration:

• Interface between marketing and science
• Involved as a regulatory consultant in the development of national and international marketing strategies

Position requirements:

• An advance degree is required (e.g. Pharm D, MD, Ph D)
• German as native language or at least excellent German language skills
• Must have demonstrated a strong command of English language (oral and written)
• Thorough understanding of EU regulations, compliance and industry standards relating to communicating product information to HCPs and/or consumers
• A team player, assertive communicator, and willingness to continuously learn the disease state, product, etc.
• Proficiency in medical writing, able to correctly understand, correctly interpret, and accurately communicate scientific data and statistical analyses
• Excellent communication (written, verbal, presentation) and analytical skills in a dynamic environment
• Proven competency in utilizing literature search engines
• Proven ability to effectively work and thrive in a multi-cultural and cross-functional environment, while building strong relationships with levels of people and teams
• Proven ability to work within a multi-functional team (legal, regulatory, medical, etc)
• Proficiency with Microsoft Office applications and document management systems (e.g. Share Point, Veeva Vault,)
• Able to multi-task and prioritize projects
• This role is located in Germany, Frankfurt area is beneficial but not mandatory

Compensation & Benefits:

• Flexible approach to where and how we work, regionally based
• Competitive compensation package including bonus
• Stock options and RSU awards
• Employee Stock Purchase Plan (ESPP)
• Generous paid holiday schedule and winter break

Additional Information: