Medical Affairs Manager
Alkermes, Inc. - Waltham, MA

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Alkermes is a leader in innovative medicines that address the unmet needs and challenges of people living with debilitating diseases. As a fully integrated global biopharmaceutical company, Alkermes applies our scientific expertise, proprietary technologies, and global resources to develop products that are designed to make a meaningful difference in the way patients manage their disease. Our track record for successful drug development is evident from the more than 20 marketed drugs that use our proprietary technologies, and perhaps most clearly exemplified by the five key commercial products propelling our growth. These are breakthrough products in major disease areas, such as schizophrenia, addiction, and multiple sclerosis.

Alkermes is in an exciting phase of growth that few biotechnology companies achieve, with our diversified portfolio of commercial products and an exciting late-stage pipeline. We are moving ahead with global capabilities, an established approach to innovation, world-class manufacturing, financial strength, and our experienced and dedicated people.

To achieve our goals for continued growth, the new position of Medical Affairs Manager was created in the Medical Affairs Team. The incumbent will be responsible for performing and managing activities in support of a wide range of areas within Medical Affairs, collaborating on the development and revision of clinical and scientific external customer materials such as slide sets, standard response letters, poster abstracts, training materials and other technical materials that will support both field-based and Medical Communications activities. The incumbent also will serve as a clinical and technical resource responsible for the provision of scientifically-based information in support of conventional Medical Liaison activities. The MAM will assure compliance with policies and procedures in accordance with FDA regulations, Alkermes SOPs and processes as they relate to the updating and development of all clinical and medical materials and the role and activities of medical communications and field-based medical personnel. The professional is expected to continuously maintain a proficient level of expertise and knowledge within the assigned therapeutic areas as well as product clinical updates and advancements. This person will combine Medical Communications, Publications and liaison activities.

Knowledge/Skills Needed:
  • Produce high quality medical copy materials such as slide decks, primers, standard response letters, etc.
  • Serve as an in house scientific expert for Vivitrol and its utilization as a treatment for addictive disorders.
  • Provide clinical and technical support acting as Liaison as needed
  • Upon request, deliver approved, fair-balanced disease state, clinical and scientific presentations to KOL audiences, managed care settings and other groups of external customers in the field.
  • Upon request fulfill unsolicited requests for information regarding Vivitrol (i.e., MIRFs)
  • Ensure that slide sets, standard response letters and collateral medical communications materials are produced in accordance with Alkermes’ standard operating procedures (SOPs)
  • Participate in and advocate the process flow for the Medical Affairs/CCC review on all newly prepared and updated clinical documents/materials.
  • Maintain and update knowledge and expertise relevant to the area of addictive medicine and proactively share insights and relevance with the Medical Affairs and Medical Communications teams.
  • If requested, prepare technical sales training materials and present to sales representatives.
  • As appropriate, attend meetings and congresses to interact with the team and proactively attend symposia, plenary sessions, etc.
  • Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks,
  • Ability to work in a collaborative environment, desire to learn and improve skills,
  • Ability to communicate scientific information to non-scientists, willingness to educate internal team
Education & Experience Requirements:
  • Advanced Scientific Degree (or Bachelors with substantial industry experience)
  • Training in development and management of electronic resources
  • BS Pharmacy, Pharm. D, BSN, MD, MSN, MPH, or PhD in life sciences MSL experience preferred
  • Medical writing, editing, or publication experience preferred
  • Substance Abuse or behavioral health experience preferred
  • Prior Industry experience or clinical practice experience required
  • Excellent writing and presentation skills
  • Excellent organizational skills
  • Excellent communication skills
  • Strong computer skills
  • 1 to 3 years experience developing scientific content
  • 1 to 3 years experience with Publications, Scientific Communications, Documentation or Scientific Department of a Pharmaceutical or Biotech company or scientific communications vendor or as MSL

Skills and Knowledge
  • Knowledge of the scientific field, experience in CNS, preferably Addiction Medicine
  • Collaborative work
  • Sense of urgency, high quality standards, high ethical behavior and compliant work
  • Medical affairs/communication experience preferred.
  • MSL experience preferred
  • Ability to critically analyze and synthesize complex scientific information
  • Excellent data interpretation and presentation skills.
  • Ability to think strategically and work independently.
  • Demonstrated ability to manage several projects simultaneously.
  • Excellent interpersonal skills, matrix management, negotiation, and leadership skills.
  • Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.

Physical Demands
  • Long hours of computer work
  • Extensive traveling
  • Ability to present and discuss

Travel Expectations:
  • Overnight travel 10 to 25%

Alkermes, Inc. - 16 months ago - save job - block
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