Senior Director, Medical Information and Scientific Communication

R&D Malvern, Pennsylvania


Description

Job Summary - a concise overview of the job

 

The Senior Director, Medical Information and Scientific Communication is responsible for leading strategic planning for Medical Information (MI) and Scientific Communication business processes and business system optimization and ensures efficiency and effectiveness of the respective teams. The Senior Director is a member of the Medical Affairs Leadership Team and works closely with all functions in Medical Affairs to optimize efficiency, effectiveness and compliance.  Directly manages the Head of the Call Center, Medical Information (MI), and Scientific Communication.

 

This role is responsible for the overall vision and strategy of the Medical Information function including the Call Center. This role helps ensure the MI function is optimized to provide timely information to HCPs and patients.  The role will ensures seamless relevant data dissemination to Pharmacovigilance, Quality, Legal, Compliance and relevant stakeholders in a compliant manner.  This role also ensures that 2nd line questions (not able to be handled immediately by the Call Center) are answered with the highest quality and speed by the accountable staff.

 

In addition, this role ensures that senior staff is prepared, as well as ensuring timely and high-quality review of promotional materials and support final approval of MI scientific writing assets.

 

This role is responsible for overall management and execution of the therapeutic area publication plans. This role is expected to contribute significantly to identifying the strategic objectives for each therapeutic area as well as identifying the optimal channels for communication of data by thorough understanding of the therapeutic area publications and societies where such data are presented/published.

 

The Senior Director will develop strategic objectives to support appropriate use of Endo products and communicate information within Medical Affairs and other Endo functions in order to better understand experiences with Endo products. The position will also oversee and manage an internal MI team, Scientific Communication team providing guidance and decision making for Endo initiatives.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

This position oversees the processes and policies within Medical Affairs and those that intersect Medical Affairs and other departments within and outside of R&D.  Effective and continuous collaboration with Commercial, Compliance, Legal, and Finance is required.  Is responsible to ensure the Head of the Call Center’s daily oversight meets with Medical Information vision and strategy. Is responsible to provide leadership for establishing publication strategies, development of publication plans and implementation of publication-related projects.

 


 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

 

Medical Information

Call Centers

§  Provide strategic oversight of external customer Call Center activities to ensure compliant and efficient processes are followed.

§  Ensure policies and procedures allow for information flows from internal and external sources to facilitate the dissemination of accurate, timely, consistent, and balanced information to internal and external customers.

o   Customers include external healthcare professionals, internal Endo personnel, and sometimes consumers/patients.

§  Work independently yet ensure strategic alignment of information with key internal stakeholders and experts, as necessary.

§  Ensure policies and procedures allow for research, review, and approved scientific research and responses to customer inquiries.

§  Ensure policies and procedures allow for effective and compliant response to unexpected events (e.g. product recalls, changes in FDA guidance’s) as well as Quality complaints

25%

Medical Information

§  Ensure policies and procedures allow for the proactive complaint development of medical response documents, creation of customized responses, and revision/update existing documents in database.

§  Ensure that review and approval of scientific medical response documents, written by colleagues in the department, occurs in a high-quality, quick and complaint manner.

§  Ensure, when required, review and approval of product-related branded and/or non-branded material intended for promotional purposes, including any product-related material developed for internal sales training, reimbursement material, and any information intended to be disseminated outside Endo.

§  Develop and implement policies, practices and procedures.

§  Oversee the strategy of plans to assist in successful product launches, manage integration of new products

§  Assist in education of staff and internal partners on therapeutic areas of interest, product characteristics as needed.

35%

Scientific Communications

§  Responsible for the development of publications strategic plan supporting Endo sponsored studies, as well as those conducted collaboratively with external researchers and clinical practitioners.

§  Ensures timely development and implementation of the therapeutic area publication plans.

§  Ensure that communication needs are met by linking knowledge gaps to data generated to fill those gaps.

§  Identify strategic objectives for each therapeutic area as well as identifying the optimal channels for communication of data by thorough understanding of the therapeutic area and societies where such data is presented/published.

§  Responsible to develop and implement quality control measures as needed to ensure accuracy of data to be communicated.

40%

Total

100%

 


 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  Pharm.D., MD or PhD, with Medical Information, Scientific Communication experience required and a minimum 10 years of experience in pharmaceutical industry.

§  People Management skills required.

§  Medical writing/editing experience for scientific/medical journals.

§  Management of agency vendors and writers.

§  Budget development and management.


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Knowledge of Medical Information and Scientific Communication processes and industry standards.

§  ICMJE Guidelines, Good Publications Practice, PhRMA code GCP, ICH guidelines knowledge and eCTD requirements.

§  Knowledge of federal regulations pertaining to the fair and balance promotion of medicines.

§  Strong knowledge and ability to master multiple therapeutic areas

§  Strong biomedical literature evaluation skills.

§  Computer literacy is required (MS OFFICE).

§  Knowledge of inquiry response management systems or capabilities.

§   Excellent verbal, written, and overall communication skills.

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Experience supporting a pharmaceutical company medical information, scientific communication team and/or managing a medical information call center.

§  Leadership skills, creating a vision and successfully meeting goals.

§  Ability to manage and mentor medical information and call center staff.

§  Customer-oriented approach and ability to effectively work in cross-functional teams.

§   Ability to prioritize and manage completion of multiple deliverables simultaneously with high quality and professionalism as well as set priorities for team.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§   Up to 10% overnight travel.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.