Medical Head Job Description

Medical Head Job Description

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Medical head provides medical and scientific expertise/input to Business Development activities, Global Business Franchise (GBF) strategies, Medical Communications, Research, Preclinical Pharmacology, Biomarker development strategies, Clinical Operations, Regulatory Affairs, and Global Drug Safety.

Medical Head Duties & Responsibilities

To write an effective medical head job description, begin by listing detailed duties, responsibilities and expectations. We have included medical head job description templates that you can modify and use.

Sample responsibilities for this position include:

Lead and develop the Global Therapeutic Area (TA) Medical Affairs team (including US Medical Affairs team)
Identify and develop the medical communications capabilities required to support Global Medical Teams and International Medical Affairs, including definition of the medical communication channels required to support efficient and effective scientific exchange
Responsible for oversight of the International Medical Affairs’ in-year implementation of TA global medical plans
Oversee medical and scientific accuracy aspects of the global Medical – Legal – Regulatory (MLR) materials review process
Manage the Global Medical Communications budget to within defines tolerances
Monitor Global Medical Communications performance and implement initiatives to drive organizational excellence
Define TA global medical strategy, appropriately aligned with overall Business Unit (BU), Product Strategy Team (PST) and Development team strategy (as appropriate)
Serve as the GMA lead on the BU leadership team and coordinate ongoing R&D activities for inline products in conjunction with other R&D functions as appropriate
Member of GMA Leadership Team (GMALT) to help define and implement global medical strategies, plans and projects
Act as a senior company representative interacting with external scientific leaders, patient advocacy groups, regulatory authorities and other appropriate external bodies

Medical Head Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Medical Head

List any licenses or certifications required by the position: BLS, CPR, AHA, BCLS, IV, MD, DEA, PEARS, 9001, ISO

Education for Medical Head

Typically a job would require a certain level of education.

Employers hiring for the medical head job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and University Degree in Medical, Education, Science, Healthcare, Business, Medicine, Management, Pharmacy, Graduate, Life Science

Skills for Medical Head

Desired skills for medical head include:

FDA requirements
Dose-response
Pharmacokinetic
Changing U.S. payer and provider landscape
Medical Affairs
Drug development regarding preclinical
Encompassing business strategy and market trends
Encompassing medical strategies and market trends
Market preparation and access requirements
Therapeutic area

Desired experience for medical head includes:

Track record of effective QA leadership for GCP- Clinical and Medical Compliance
Experience leading, training and/or implementing root cause analysis of audit observations for systemic improvement
Experience in “turn around” compliance improvement activities
A relevant healthcare degree is required
Establish and maintain a compliant environment in line with company and external standards, policies, guidelines and laws, including adherence to CIA
Requires some domestic and international travel

Medical Head Examples

1

Medical Head Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of medical head. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for medical head
  • Responsibility and accountability for the financial management and reporting requirements for NA medical affairs, including supporting the Finance reporting process with accurate and timely data and assumptions as needed to support budgeting, forecasting and long range planning for the business units
  • Support the objectives of Medical Affairs through strategic leadership of the Country medical associates
  • In support to the Head of Risk Management, supervises assigned team of Risk Management specialists for various therapeutic areas and/or products
  • Head Quality Medical Device C&S is accountable for the establishment, control and improvement of all quality systems / SOPs with regards to ISO 13485 and 21 CFR 820 and CFR 4 for medical devices and combination products within BTDM Quality according to legal and internal Novartis requirements
  • He/She ensures risk management processes for medical devices according to ISO 14971 and IEC 62366
  • Accountable for the analysis and trending of relevant product and quality system data for management reporting and its coordination and mitigation in case of negative indicators
  • Development and revision of QA Agreements and Service Level Agreements of suppliers, third parties and service providers and support of related supplier audits
  • Coordination and evaluation of claims notification of authorities in case of notifiable incidents or Field Safety Corrective Actions (FAs, MDRs) and related intercompany escalations
  • Coordination and development of Post Market Surveillance Reports
  • Participation as QA representative at interface meetings with Device Development & Commercialization and other peer functions for Quality Topics and permanent improvements QA Representative in Design Teams
Qualifications for medical head
  • Prior experience in a B2B environment
  • At least 10-12 years of pharmaceutical industry experience, the majority in traditional and global pharmacovigilance departments, with at least 4 years of experience managing, mentoring and training other safety physicians
  • Accountable for the investigation, risk evaluation and correction of compliance issues related to Medical Devices
  • Investigation and mitigation of medical device related product issues like complaints, adverse event reports and general product issues in regard to medical devices (MD) and combination products for the MD as constituent part
  • Accountable for the implementation and maintainance of all required Medical Device Certifications and Management Reviews for all product and combination products manufactured with cGMP, legal & regulatory requirements and the Novartis Pharma Corporate Quality Manual
  • Accountable for the Quality Oversight of external partners contractors and suppliers
2

Medical Head Job Description

Job Description Example
Our company is growing rapidly and is looking for a medical head. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for medical head
  • Work seamlessly with the Franchise Head to provide overall leadership and accountability for all franchise medical team activities
  • Leads, recruits, coaches, develops and manages head office Medical herapeutic Area Teams and field MSL Manager
  • Responsible for management of US MSL field force, including training department
  • Oversee the US IIT process, from receipt of proposals through approval, including IRC approval process, budget negotiation, contracts, and study execution
  • Integrate global regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development
  • Leading and providing strategic regulatory guidance and delivering the global regulatory strategy for product development, manufacturing and registration on Medical Devices, Assays and Equipment
  • Building and maintaining a credible relationship with worldwide regulatory authorities with effective written and verbal communication related to registration of Medical Devices and Equipment
  • Carrying out regulatory registrations and listing
  • Manages numerous, potentially cross-discipline teams of professionals and is accountable for the performance and results of the teams
  • Provide guidance and coordinate registration / notification / listing activities together with the local regulatory units of the sites / local agents / subsidiaries
Qualifications for medical head
  • Experience working as a Finance Manager/Director and thorough knowledge of accounting principles both locally and abroad
  • Graduate in Chemistry, Pharmacy, Microbiology or Biotechnology or another related science
  • 5 years of experience in Quality with focus on Compliance and Risk Management of biopharmaceuticals drug products
  • Expert knowledge of medical device quality requirements is desired
  • International experience preferable
  • English fluent in speaking / writing, German and/or French desirable
3

Medical Head Job Description

Job Description Example
Our company is hiring for a medical head. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical head
  • Providing leadership, mentoring, supervision and over-sight for the Medical Affairs Bone team, including setting and implementing strategic direction
  • Ensures that relevant changes to product registrations and listings are properly notified to the relevant authorities
  • Ensuring manufacturing sites and distribution comply with regulatory requirements and good regulatory practices
  • Responsible for vigilance reporting to Competent Authorities
  • Prepare regulatory assessments and regulatory action plans in the product development process (PDP)
  • Interface/partner with Marketing, Commercials, Manufacturing sites, Operations, Distribution, Trade Compliance, R&D, QA, QC and Regional Regulatory units
  • Leading new global strategic Medical devices and Equipment regulatory projects within MilliporeSigma Life Science
  • Provide regulatory support and guidance to marketing and commercials via seminars / trainings / events
  • Strong interpersonal skills, ability to manage and communicate across boundaries, build cross-functional collaboration, and influence with and without direct authority
  • Ability to influence with authority within a matrix organization and cross function disciplines
Qualifications for medical head
  • Prepare audit reports and communicate directly with external auditors
  • Develop accounting systems for AP, AR, Credit Control, and Cash Management
  • Deep understanding of SOX
  • Complete oversight across therapy area (franchise) with mix of direct management and 2nd line leadership across head office and field teams
  • Involvement in full lifecycle of product development from early clinical development to launch activities in global and local clinical development programs
  • Strong medical infrastructure with functional experts on hand across Medical Information, Regulatory Affairs and Pharmacovigilance to support you in achieving your franchise strategies
4

Medical Head Job Description

Job Description Example
Our innovative and growing company is looking to fill the role of medical head. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for medical head
  • Ensuring medical affairs effective & quality input into the country access plans and their execution
  • In anticipation of product launch, the Medical head will ensure that he/she and his/her team provide medical support, education and guidance to commercial, marketing and sales teams
  • Promotes quality culture in the GBU
  • Ensures team develops the same level of support across the GBUs to properly implement the Quality System
  • Contribution of medical insights for business plans in order to gain access into health care systems
  • Lead Key Opinion Leaders (KOL) engagement and knowledge development
  • Ensure that medical guidance is proactively provided to marketing and sales teams
  • Contribute strategic guidance to relevant cross functional Product Teams
  • Provide leadership identifying needs for post-marketing clinical trials and oversee their management and execution
  • Represent the MS business unit at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KOLs
Qualifications for medical head
  • Be very involved with the budget preparations and general accounting tasks
  • Provide timely and accurate financial reports and statements abiding by GAAP standards
  • Ensure proper policies and procedures are in line with company compliance
  • Proven track record of leadership development, UK and global career opportunities and flexible working practices
  • MD or advanced scientific degree, PhD, PharmD or equivalent
  • Ability to establish productive and compliant professional relationships with key opinion leaders and medical/scientific professional societies
5

Medical Head Job Description

Job Description Example
Our company is hiring for a medical head. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for medical head
  • Hires, mentors and develops Medical Communications, Medical Publications and Medical Information, MedEx staff
  • Provides leadership to staff and outsourced vendors to ensure that the execution of medical communications, publications and information, training and education plans are consistent with corporate and department objectives, and within budget
  • Guides and supports staff for project-related matters and sharing of best practice
  • Forecasts and secures resources (financial and personnel) – with business case preparation, as appropriate
  • Establish and promote the medical and scientific reputation of the France affiliate
  • Collaborate with the mid-sized and smaller affiliates (Belgium, in this case) to leverage subject matter expertise and pooled resources from France in order to optimize use of resources and spend across countries as needed
  • Lead development of the affiliate Medical plan aligned with regional and worldwide Medical plans, partnering with affiliate management teams, including Market Access, Marketing and Sales, and other functions to define, establish and execute a coherent local business plan that addresses patient needs
  • Identify current and future unmet medical needs, addressing those needs to EU+ Regional Medical, and generating short-, mid-, and long-term plans
  • Play a key leadership role within EU+ Regional Medical, including providing best-practice sharing across countries, therapeutic areas, and products
  • Partner and collaborate with Commercial and Market Access to demonstrate medical value of BIIB products relevant to local external stakeholders (payors, HCPs, agencies) and patients, which may include providing input to clinical trials (pre- and post-marketing), developing and executing phase IVs, registries, and patient support programs
Qualifications for medical head
  • Preferred Dermatology and/or Immunology/Rheumatology experience or specialization
  • 3-5 years experience in efficient and effective office management
  • Previous work in international environment
  • Good computer skills (MS Office, Visio, SAP of advantage)
  • Experience in working in international teams across different locations
  • Requires a graduate degree

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