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Medical Manager Biomarkers

hace 2 meses

Madrid, España AbbVie A tiempo completo

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

MEDICAL MANAGER BIOMARKERS

Rationale for requirement:

  • Prominence of specialty products in AbbVie portfolio requires internal scientific/ medical expertise

  • Specific competencies are required to initiate, develop, and manage medical programs

  • A dedicated specialist is required to manage compliance with all applicable national laws & regulations, guidelines, codes of conduct, AbbVie policies & procedures, and accepted best practice (in particular concerning promotional documents review, clinical programs, medical information, clinical education)

  • Need for scientific/ medical input on training courses to support other in-field Brand Team functions in understanding medical messages

Key Responsibilities

  • Propose a medical strategy within the Brand Team, providing expert medical input within the Brand Team and according to local resources and regulations, build brand-aligned Medical activities

  • Collaborate in the execution of the Brand medical strategy as defined in the Brand Plan together with the defined functions as per plan.

  • Sustain professional and credible relationships with national KOLs/ academic centres and ensure that the medical value messages on the products/ areas of therapeutic interest are conveyed and identify topics of interest among healthcare professionals and work with collaborative clinical groups to define Medical / scientific programs and activities including conducting Advisory Boards where appropriate

  • Provide input, review and sign-off of all promotional materials, label changes and product monographs to ensure compliance with local and corporate requirements and provide medical/scientific support to the Regulatory Affairs Department.

  • Review and sign-off of press releases.

  • Build scientific content of symposia and cover scientific meetings/ congresses on behalf of the company and co-manage national Clinical Education programs and ensure the validity of the scientific content

  • Manage local clinical/scientific programs in line with Brand Team and corporate requirements and ensure publication of the results of programs according to the brand publication plan to ensure the highest standards in the medical excellence score card.

  • Input in the core value proposition dossiers

  • Input, review and execution together with the training department of the brand specific internal training

Relationships

Internal:

  • Regulatory Affairs Department in the Affiliate.

  • Therapeutic Business Unit.

  • AbbVie International Clinical Development Operations

  • Clinical Research Manager. Affiliate Operations Manager.

  • CRAs, personnel in charge of the management with the Ethics Committees of Clinical Research and other Authorities.

  • Pharmacovigilance Unit in the Affiliate.

  • Local or international Clinical Project/Study Managers.

  • Medical Department administrative staff.

  • Documentation Service.

  • Training Department.

External:

  • National Key Opinion Leaders.

  • Providers (statistical companies, medical writers…)

  • CROs involved in the studies.

  • Participating investigators and sites.

  • Scientific institutions and corporations.

Qualifications

Knowledge

  • At least, Bachelors degree in a scientific discipline; or Medical degree

  • Familiarity with GCP, international & local SOPs and knowledge of approval processes for clinical programs and outcomes

  • Working understanding of clinical and statistical research methods

  • Knowledge of the processes involved in clinical/ scientific research publication

  • Good knowledge of the international, European and local regulations that apply to the different types of studies which are performed in the Clinical Research area.

  • Knowledge of solid tumours biomarkers environment

  • High English level and of the local language

Experience

  • At least 4 years of experience as medical manager in the Pharmaceutical Industry within the biomarkers area, ideally in Ovarian Cancer or Solid Tumours space.

  • Academic and professional scientific background, including 2-3 years experience of clinical & scientific research and/ or education programs.

  • Experience in working in a matrix organisation.

  • Experience in publishing as author or co-author.

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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