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Medical Affairs Manager for Antiseptics- United States

Norcross, US

At Molnlycke, we care about making people better - those who work for us, those who work with us, and we prove it every day! 

In our daily work, we create unique medical solutions to improve quality of life. We enjoy what we do because it makes a real difference in people’s lives. Although we’re a global company, we’re still small enough for you to make your mark. Our leaders are accessible and trust us to make the right decisions. As a Mölnlycke employee, you’ll thrive when you take on the responsibility.      

We are currently searching for Medical Affairs Manager for AntisepticsThis person will be based in a Home Base Office anywhere in the United States of America.

 

The Medical Affairs Manager for Antiseptics owns the indication(s) of the assigned products/drug categories and is the medical-scientific link between the healthcare community and MHC. The position serves to support the three strategic pillars of the medical affairs department, within the respective antiseptics/pharma business area:

  1. Evidence generation
  2. Evidence dissemination
  3. Customer engagement

The MA-Antiseptics role is focused on developing and maintaining peer-to-peer relationships with key medical, clinical and research experts to support the planning and implementation of clinical trials, evidence generation activities and aggregation of customer insights. The MA manager executes all activities with respect to relevant and appropriate pharmacovigilance considerations of the drugs/products within the business area and respective pharma regulations associated with the region/country of business activity. At times, the role will work collaboratively with other business areas to deliver on “one-Molnlycke” initiatives. The MA manager conducts engagements with internal and external customers by role modelling Mölnlycke’s high performance behaviours, displaying integrity and a non-judgmental, positive attitude

 

KEY ACCOUNTABILITIES

  • Is the subject matter expert for pharmaceutical regulations associated with the products/drugs in the respective country of sale.
  • Is the subject matter expert of medical information associated with product/drug indications, in-vitro, in-vivo and human clinical trial evidence while serving cross-functional teams
  • Train internal stakeholders on key scientific and medical topics relevant to the therapeutic or clinical area
  • Develops a working knowledge of the regional landscape and understanding of customer needs in target markets. This may include a healthcare provider (HCP), patients, procurement/value analysis professionals and other key customers as relevant to the strategy and care of patients
  • Maintain effective and appropriate communication among internal stakeholders while maintaining full compliance with relevant requirements
  • Collaborates with clinical affairs team to support the development and execution of clinical research to support business area strategy and market-access-development-plans
  • Develop evidence-based regional support plans based on evidence and clinical needs, value added support and customer engagement
  • Collaborate with experts and internal stakeholders on medical affairs initiatives including publications, advisory boards, medical education opportunities, training and speaker development
  • Builds long term relationships with key opinion leaders in target markets which support or expand current therapeutic concepts and ensure safe and appropriate utilization of products
  • Develops competency in universal, intraoperative conduct and follows regional and/or facility requirements for participating in the observation of surgical procedures
  • Ensures adherence to relevant regulatory requirements, good clinical practice (GCP) and company standard operating procedures as appropriate

 

KEY DECISIONS

  • Provide clinical oversight for medical safety and product complaints
  • Identifies qualified key opinion leaders to support strategic initiatives and determines fair-market-value
  • Identify and grade strength of evidence of appropriate literature associated with support of the business strategy
  • Direct and support the publication process including manuscript creation, determination of authorship and selection of peer reviewed journals for the placement and dissemination of key study results to support commercial strategy
  • Collaborate with the global evidence committee to review, score and approve/decline quality improvement projects (QIPs) based on applicable global and regional regulations separating human subjects research from quality assurance and performance improvement activities

 

CAPABILITIES; QUALIFICATIONS AND EXPERIENCE

  • Clinical/scientific background (PharmD, PhD, RN) with 3+ years of experience as pharmaceutical medical science liaison or medical affairs role.
  • Must have pharmaceutical regulatory experience and be capable of advising internal and external stakeholders on the accuracy of product information and requirements within the country(s) of sale.
  • Capability to critically appraise, interpret and communicate research studies and scientific information
  • Experience in the design, implementation or execution of clinical trials and/or in vitro studies is preferred
  • Capability to independently develop and implement strategic action plans for evidence generation and evidence dissemination
  • Pharmacovigilance training and understanding of applicable regulations associated with respective drugs/products managed by the business area
  • Experience with medical safety oversight in pharmaceuticals including risk assessment
  • Proficiency in the English language and excellent communication skills
  • Capability to develop and present oral presentations to key stakeholders when appropriate for internal or external training
  • Leadership capabilities to manage, lead and engage internal and external stakeholders

 

ADDITONAL INFORMATION

  • Location (Remote): There is no specific geographic office assignment for this position ( US -Central or East  is preferred)
  • The Medical Affairs Manager may work remotely per the established global guidance on remote working principles
  • International travel is required to support the business areas in strategic areas of focus, to engage with key opinion leaders, support research initiatives and network at appropriate clinical congresses
  • The Medical Affairs Manager may follow global guidance on flexible working hours especially when business activities involve regions in different time zones

 

ADDITIONAL RESPONSIBILITIES

  • To challenge, innovate and inspire new ways of working, especially those that improve the efficiency, effectiveness and cost-effectiveness of strategic initiatives set forth by the medical director.
  • To provide creative insights into novel areas of geo-expansion, new market development and associated evidence needs, including identification of key opinion leaders
  • Support business development activities for the potential licensing or acquisition of products/drugs/companies as requested by the medical director

 

 

About Mölnlycke  

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home.   

We specialize in:   

  • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex®  
  • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients  
  • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves  

Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customized trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world.