Manager, Scientific Communication and Outcomes Research
Hologic - Marlborough, MA

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Hologic, Inc. (NASDAQ: HOLX) is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems, and surgical products dedicated to serving the healthcare needs of women throughout the world. Historically, Hologic developed, manufactured, and marketed products focused on mammography, breast care, and osteoporosis assessment. Our core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. For more information visit www.hologic.com

Role

Manages scientific publications for clinical and healthcare outcomes research as a shared service asset, across Hologic business units and product lines. Integrates priorities and effectively manages timelines, communications and publication-related activities for bench studies, clinical trials, health outcomes and investigator initiated research.

Essential Duties and Responsibilities

Develops and executes a master medical communication plan for abstracts, posters, presentations, and manuscripts:

• Creates a comprehensive annual timeline and workflow for each business unit to co-ordinate clinical/research activities and ensure timely project delivery

• Articulates publication strategy to internal and external partners; generates project and meeting updates

• Facilitates meetings and conference calls among cross functional groups which may include Managed Care, Medical, Clinical and Regulatory Affairs, Consultants or contract resources, Research and Development and Marketing to plan and review data, discuss progress and resolve challenges

• Anticipates delays and recommends solutions to meet timelines and minimize impact on other projects

Manages writing, writers, Scientific Communication Specialist(s) and contract resources:

• Provides or supervises content development from draft outline to submission of abstracts, manuscripts, posters, platform presentations, white papers and dossiers

• Primary point of contact for internal and external authors and investigators concerning publication production and co-ordination

• Forecasts and manages milestones and budgets for publication-related activities for Hologic research, outcomes projects or investigator initiated studies

• Conducts literature searches and reviews to support a variety of cross functional department projects (Managed Care, Health Outcomes, Clinical)

• Develops and reviews abstracts, posters, slides, and manuscripts critically for content, data validity and scientific merit

Ensures compliance with all external guidelines and Hologic policies on publication practices:

• Coordinates promotional review and or Marketing Literature Change Order (MLCO/ Agile) review of posters/slides/abstracts and manuscripts as required, and attends MLCO meetings

• Tracks abstracts and manuscripts through submission and review pathway

• Directs accepted abstracts and finalized content to Managed Care, Medical Education, Medical and Scientific Affairs, Executive staff and other groups as appropriate

• Maintains a file of published and unpublished manuscripts

• Assures process for retention of reference materials and documents for ongoing and future activities

Contributes to protocol development:

• Participate in protocol development discussions or review draft protocols to provide publication perspective and key considerations for successful and timely publication of research results

• Review protocols and study materials to ensure the integration of patient-reported outcome, health-related quality-of-life measures and medical resource use into clinical programs

Qualifications

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Experience and knowledge in the following areas are required: successful record of implementation of medical communication programs; publication management; database medical searching; demonstrated knowledge of the medical device process and regulations governing publication practices; working knowledge of clinical program management, marketing communications, FDA regulation of medical device and prior history managing consultants and vendors

• Ability to identify customer needs and maintain and support a customer service philosophy. Ability to use analytical and decision-making skills to offer options and resolve problems in a variety of contexts

• Experience in clinical and medical research with documented publication history

• Budget management and forecasting responsibilities of $500K

• Management of cross matrix responsibilities, team members and external agencies preferred

• In-depth knowledge of ICMJE, good publication practices and data disclosure requirements

• Occasional overnig ht travel required

Education

Education

• Masters in Science related field. PhD or PharmD preferred

Experience

Experience

• 4+ years of related experience at medical device, pharmaceutical or medical communications company

Specialized Knowledge

Additional Details

Hologic - 19 months ago - save job - block
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