Medical Affairs Director, MCRP
MSD
Job Description
Job Description In Primary Posting Language
Job Description:
The Medical Affairs Director, Medical Consult and Review Physician (MCRP) provides clinical expertise and advice to internal stakeholders and is a member of several cross-functional teams, including the Promotional Review Team (PRT), and the US and Global Medical Affairs Teams. In PRT, the Medical Affairs Director, MCRP is responsible for ensuring the clinical relevance and medical accuracy of data/information in promotional materials, external communications and field-based employee training. The Medical Affairs teams guide the medical affairs organization’s strategy within the therapeutic area. The Medical Affairs Director, MCRP also leverages clinical practice & therapeutic area expertise to participate in the strategic planning and global scientific content development, review of standard response document (SRD) on product safety and efficacy, and when required, interact with HCPs to help answer unsolicited medical information requests (MIR). The Medical Affairs Director, MCRP provides medical and scientific training to internal stakeholders and collaborates to develop training content and implement scientific updates. The Medical Affairs Director, MCRP provides medical consult for Medical Significance Assessments of company products as it relates to deletions, divestitures, and supply issues.
Accountabilities
Medical Review of US and Global Promotional Materials
Provide clinical expert guidance and advice to Commercial Brand Teams in order to influence promotional strategy and messaging based on scientific evidence and clinical context.
Member of Promotional Review Team (PRT) responsible for ensuring the clinical relevance and medical accuracy of data/information in promotional materials, external communications and Field Based Employee (FBE) training content.
Support Country Medical directors, as HQ point of contact and Subject Matter Expert (SME) for medical review.
Serve as product SME during GMA global assurance process for country assessment.
US and Global Medical Information
Leverage clinical practice & therapeutic area/product expertise to provide actionable insights for the strategic planning and global scientific content development of medical information assets, ensuring adequate integration of data and scientific evidence with patient safety and clinical relevance elements in a customer-centric approach.
Review all medical information resources and standard response documents containing product safety, tolerability and efficacy data. Interact with HCPs who request a live discussion with physicians to answer MIRs.
Proactively engage with leaders and participate in US and Global Medical Affairs Teams to ensure that sufficient medical information assets are available with the appropriate depth/format to meet the requirements of external customers and internal stakeholders.
Review Health Outcomes-related standard response documents and AMCP dossiers to ensure clinical relevance and medical accuracy of the content.
Strategic Coordination and Alignment
Proactively engage with Global Scientific Content (GSC) team lead and team members, and actively participate in the product strategic planning, ensuring a tailored approach in creating and disseminating scientific content aligned with key scientific priorities and the GSC plan.
Leverage SME, clinical practice expertise, and therapeutic area team participation to contribute with actionable insights and inputs into key medical strategy teams (regional and global). Provide medical significance assessment to inform product deletions, divestitures, stock-outs and shortages.
Proactively engage in peer-to-peer conversations with key colleagues in our research division to provide/request input and ensure alignment to enhance the provision of accurate and customized Medical Information assets for customers and stakeholders.
Active participant on selects teams to provide insights on labeling language and anticipate activities related to labeling updates, and to facilitate timely and efficient SRD development and/or updates to support addressing MIRs.
Actively contact and interact with Risk Management Safety Team(s) when required.
Act as SME for creation/update of GMA process/SOPs.
Engage in Medical Significance Assessments of company products as it relates to deletions, divestitures, and supply issues.
Medical Education and Training
Support creation of medical training curricula for the products, to address basic and advanced training needs of GMA personnel.
Collaborate with Learning & Development and Content Training Directors to develop training content and approve training resources for the field medical affairs group.
Implement Speaker Training activities for US/ex-US speakers participating in our company’s Medical Forum programs.
In collaboration with the GMI group, support sales and internal training activities
Participate in training and/or mentoring of new team members.
Qualifications
Education Minimum Requirement:
MD or equivalent medical degree is required.
Post-graduate clinical training (residency) and a minimum of 5 years of clinical practice is required.
Required Experience and Skills:
Understanding of regulations and compliance considerations impacting pharmaceutical industry.
Must be able to work in a complex organization environment and have ability to effectively operate in a team-oriented structure.
Ability to analyze/synthesize data and provide solutions and formulate strategies.
Must have excellent interpersonal and communication (written as well as oral) skills.
Preferred Experience and Skills:
Board certification or eligibility in a medical specialty related to Oncology is highly desirable.
Relevant working experience in Medical Affairs in the pharmaceutical industry is desired.
Relevant working experience in Medical Information or Clinical Research (in academia or pharmaceutical industry) is desired.
NOTICE FOR INTERNAL APPLICANTS
In accordance with all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:
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Flexible Work Arrangements: Hybrid
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Gwynedd, PA – Wales
Sun, 18 Feb 2024 07:06:08 GMT
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