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(Sr) Medical Advisor Rare Disease


Capelle aan den IJssel, ZH 2903 LC
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Job Details

**PIH Rare Disease Medical Advisor (M.D.)**

**Western Cluster Medical Lead Rare Disease IDM Region**

**Medical Affairs, Pfizer Innovative Health, Pfizer bv, the Netherlands**

**Job Purpose** As a key customer facing medical colleague responsible for Rare Diseases in the NLs you will:

o actively partner to articulate and address unmet medical needs and relentlessly focus on putting patients and their families first in everything that we do

o collect and share our data and knowledge, collect insights and build effective partnerships with the rare disease scientific community

Support the rare disease therapy area by implementation of local non-interventional studies, development and leverage of Investigator-Initiated Research (IIR) and Educational Grant opportunities, management of local advisory boards, interaction with local clinical investigators and other stakeholders and other key medical activities

Provide high-quality, accurate, balanced and directed information to key customers and stakeholders in response to unsolicited requests for information

Build and develop enduring (peer-peer) relationships with healthcare professionals, institutions, governmental bodies, health insurers and other customers creating constructive, cross-functional partnerships with internal and external stakeholders to generate customer insights and leverage business opportunities

**Key Roles/Accountabilities** **1. Medical contribution to the decision-making unit and cross-functional team (DMU / XFT) Rare Disease**

Timely communication to the DMU of (potential) issues and relevant clinical papers, including a regular

update on competitor information.

Keeping up with literature and developments concerning the product and therapeutic area by regular literature searches and attending appropriate scientific congresses

Medical support of the DMU with strategic information (e.g. fact sheet competitors).

Create and maintain enduring relationships with all applicable stakeholders / customers in close cooperation and coordination with the DMU.

To interact with and develop enduring relationships with regional and national opinion leaders and advisors on

clinical practice.

Attend internal business and product meetings (sales conferences, business review meetings, tactical meetings, briefing advertising agencies) and represent the medical department at these meetings.

If appropriate represent the medical department at meetings of global medical affairs / global strategic marketing, e.g. DAC meetings.

Cooperate with the other medical advisors, MSR's, clinical study manager and training department.

Scientific support of all departments in case of business critical events.

Scientific support in writing of reimbursement projects and dossiers.

Prepare, perform and update internal and external medical training.

Prepare and evaluate examinations on the training.

Back up for colleague(s) if applicable.

Medical lead for local/national Advisory Boards.

Keep abreast of scientific, translational and clinical advances in the relevant therapeutic areas within Rare Diseases.

Give external presentations about (subjects related to) Rare Diseases to external stakeholders / customers.

Working with Advisory Board members in preparation for meetings and on an ongoing basis as appropriate to gain medical insights.

Speaker briefings for symposia and congresses where appropriate.

Media briefings where appropriate, in conjunction with communications team.

Support for local medical education implementation, as appropriate.

Support for initiatives around enhancing trust and reputation, in conjunction with external affairs and stakeholder strategy.

Align activities with local strategic, STAR plan and / or DMU plan.

Evaluate the medical significance of adverse events of individual patients, which are reported during the use of registered medication during daily practice and liaise with pharmacovigilance team.

Answer of medical questions of Health Care Providers of patients about the use of medicines (off-label indications, dose adjustments, contra indications, precautions, warnings and interactions).

Assess patient participation in named patient programs and compassionate use programs.

Train Medical Information colleagues on clinical, scientific and practical advances for the relevant therapeutic area.

Discus cases with Health Care Providers who are seeking advice for individual patient treatments.

Promptly respond to urgent questions from patients and physicians in the relevant therapeutic area.

Contextualization of scientific information and translate the outcomes to the patients seen in daily practice.

**2. Clinical trials and other studies (IIR's, NIS, Collaborative Studies and Sponsored CTs)**

Contribute to the design and implement the clinical trial / medical plan for the product(s) or therapeutic area.

Coordinate and supervise all ongoing studies.

Ensure that clinical studies have a clear scientific objective, contribute to product knowledge and have documented plans for patient protection.

Ensure flawless execution of clinical studies/ IIR's in compliance with internal and external regulations.

Cooperate and coordinate ongoing and planned clinical trials with Clinical Operations and/or the Clinical Research Organization.

Working with investigators to evaluate their IIR proposals, including an assessment of study methodology, scientific rigour and what the data will add to the scientific literature.

Advise on development of IIR concept and full proposal (in line with brand IIR strategy).

Advise reactively to assess the patient eligibility according the IIR entry criteria.

Internal discussion of proposal with in country and above country medical team and submission into INSPIIRE.

Follow up with investigators, co-ordination of contract and medication supply if requested. Support for ethics and CTA applications if appropriate. Budget management and forecasting.

Regular contact with investigators throughout the study, reporting on progress.

Congress and publication planning; assess and contribute to clinical study protocols, reports and publications.

Working with investigators on Pfizer sponsored studies, including in house and Clinical Research Organization-managed trials.

Communication with investigators on key developments of the clinical trial programme and relevant scientific data as it becomes available.

Support for investigator meetings and trial steering committees.

Requesting feedback on clinical trial programme and protocol feasibilities from potential investigators.

Nominating investigators and sites for trials.

Evaluate patient assessment or volunteer participant eligibility for participation in clinical research trials.

Liaise with local investigators and pharmacovigilance team for the evaluation of the medical significance of (serious) adverse event and observations during clinical research trials.

Liaise with local investigators and study clinical lead about treatment of (serious) adverse events during clinical research trials.

Liaise with local investigators and study clinical lead and assist in assessment of clinical cases of individual patients or volunteer participants in clinical research trials reported in the clinical monitoring reports.

Liaise with local investigators and pharmacovigilance team for local monitoring activities of patient safety during the conduct of clinical research trials and conduct the appropriate tracking and follow up of adverse events, in alignment with corporate patient safety policies and procedures.

Liaise with local investigators and clinical development team for due diligence activities in order to demonstrate good conduct and reporting of clinical research trials and/or collaborative research projects, in alignment with corporate policies and procedures.

Liaise with clinical development/operations teams and provide medical information to Health Care Providers, patients and volunteer participants in clinical research trials (protocol, patient and informed consent information).

**3. Promotional material**

Ensure medical and ethical correctness of promotional materials/ messages/ actions by critical and timely review of these materials/messages/actions, while contributing to the quality.

**4. Financial/administrative**

Budget responsibility: Maintain an accurate financial monitoring system for the local clinical trials, IIR's and other medical activities.

Timely and correct entry of data of all clinical trial data in Inspire.

Ensure zero default on ethics.

**5. Compliance**

Take care of sufficient and up to date knowledge of the Standard Operating Procedures of Pfizer b.v, which are applicable for this function and conduct activities accordingly.

Take care of sufficient and up to date knowledge of ICH GCP guidelines and National regulations (CGR).

Knowledge of the applicable Code(s) of Conduct and FCPA/GPIHP and how it relates to the function of Medical Advisor

**6. All duties related to the purpose of the position**

**7. Key work relations/stakeholders**


- Western Cluster Medical Lead Rare Disease

- Country Medical Director (CMD)

- Therapeutic Area Leads in Regional & Global Medical Affairs

- Medical Affairs colleagues (Country Level, Western Cluster level)

- Marketing & Sales (Local & Regional BU)

- Pharmacovigilance (Local & Regional)

- Clinical Development (R&D; Regional)

- Medical Information (Local)

- Regulatory affairs (Local & Regional)

- Market access, Global Health & Value (Local & Regional)

- Enabling divisions ( Quality Operations, Supply, Procurement, Controlling, Accounting, Legal, Compliance and Human Resources)


- Patients and Patient Advocacy Groups.

- Key opinion leaders and investigators operating in the relevant therapeutic area.

- Dutch Healthcare Inspectorate, Medicines Evaluation Board and other healthcare authorities (Local), if appropriate.

- Clinical Research Organizations and other third parties operating clinical research environment.

- Scientific societies acting in the relevant therapeutic area.

**Experience** **and Knowledge** A medical degree (M.D.), preferably with clinical experience, or alternatively a higher academic clinical science degree with experience of clinical interactions.

Preferably 3 years of relevant pharmaceutical experience.

Fluency in business English.

Excellent understanding of clinical decision-making processes exercised by health care professionals.

Clinical research and trial management experience, and be able to interact authoritatively with key stakeholders and investigators.

Preferably GCP trained and good understanding of EU Clinical Trials Directive.

A thorough understanding of the health care environment.

An in-depth knowledge of the therapeutic area, the relevant medicines in the portfolio and the pipeline.

An understanding of the compliance framework for medical interactions in relation to the applicable regulations, Code of Practice and SOPs.

A good understanding of clinical research and the ability to critically evaluate clinical study protocols, reports and publications.

Strong presentation, negotiation and networking skills.

Business acumen.

High degree of cross-functional collaboration.

Ability to communicate clearly information and concepts which may be complex in nature.

Role modeling, upholding values, adhering to high standards.

Good knowledge of pharmacovigilance and regulatory legislation and how it impacts the product portfolio.

Good knowledge of drug development.

A knowledge of health economics and its impact on medical decision making.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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