Associate / Medical Director Job Description
Associate / medical director
provides highest level of scientific expertise through entire clinical trial process including interactions with basic research, late-stage clinical development, regulatory, and commercial colleagues within Janssen Research & Development.
Associate / Medical Director Duties & Responsibilities
To write an effective associate / medical director job description, begin by listing detailed duties, responsibilities and expectations. We have included associate / medical director job description templates that you can modify and use.
Sample responsibilities for this position include:
Contribute to and review clinical documents (slide presentations, protocols, clinical study reports, regulatory submission sections, investigator’s brochures)
Serves as a resource and consultant to other areas of the company, may chair or serve on company committees, may be required to represent the company to external entities and/or serve on external committees, conduct peer clinical and/or appeal case reviews and peer to peer clinical reviews with attending physicians or other ordering providers to discuss review determinations, provides guidance for clinical operational aspects of the program
Leads, develops, directs and implements clinical and non-clinical activities that impact health care quality cost and outcomes
Ensure appropriate dissemination of clinical and scientific information in a timely, ethical and customer-focused manner, following regulatory and compliance guidelines of the company
Manage medical aspects of the Commercial - Medical – Legal – Regulatory (CMLR) materials review process
Develops, reviews and follows up on clinical studies and medical projects initiated within the relevant therapeutic area
May assist in scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information
Has responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule
Assist with the strategic planning and execution (including study design, method selection, ) of Phase I through IV global clinical trials
Provide day-to-day clinical and medical guidance while working closely on joint projects with other members of the Medical Affairs team and other departments within Jazz
Associate / Medical Director Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Associate / Medical Director
List any licenses or certifications required by the position: CPR, ABMS, CMPP, BLS, AHA, AMWA, MD, URAC, NCQA, M.D
Education for Associate / Medical Director
Typically a job would require a certain level of education.
Employers hiring for the associate / medical director job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Medical, Life Sciences, Education, Medical School, Medicine, Medical Education, Graduate, Science, Healthcare, Pharmacy
Skills for Associate / Medical Director
Desired skills for associate / medical director include:
Biostatistics
Clinical trial methodology
Data management
Regulatory
AbbVie’s customers
Compliance and regulatory requirements
Markets
Drug development process
Clinical
Scientific and clinical research methods and clinical study design
Desired experience for associate / medical director includes:
Develop and implement medical communication plans in designated disease areas [Neuroscience
MD required, with specialization in Immunology preferred
Board Certification NOT required
Strong knowledge of Cardiology, Oncology or Geriatrics common medical conditions
Active,unrestricted medical license to practice medicine in the State of Texas required
Must possess an active unrestricted medical license to practice medicine in West Virginia
Associate / Medical Director Examples
1
Associate / Medical Director Job Description
Job Description Example
Our company is growing rapidly and is looking for an associate / medical director. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for associate / medical director
- Actively participate in the development of the Medical Affairs plan(s) for Cystic Fibrosis therapeutic areas
- Provide mentoring and supervision to junior staff, as appropriate, to ensure execution of publication plan is consistent with corporate and department objectives
- Forecast and secure resources (financial and personnel) – with business case preparation as required
- Manage medical communication agencies and freelancers
- Ensure compliance with all relevant polices and procedures
- Ensure adherence to the publication process for all publications that are in scope for Global Medical Affairs
- Responsibility for at least one group-related responsibility as assigned by the group head
- May act on behalf of Sr Director, Medical Communications, as required
- Interpreting existing policies and recommends/champions new policies based on changes in the healthcare or medical arena
- Responsible for monitoring emerging trends within the market and identify potential opportunities for provider collaboration
Qualifications for associate / medical director
- Advanced scientific degree (Ph.D., PharmD) with pharmaceutical industry or agency experience
- 3+ years of publication planning and execution experience working within the pharmaceutical industry or publication agency
- Strong scientific acumen with the ability to translate and effectively communicate complex scientific data for varying audiences
- Strong collaborator with experience working cross-functionally with key stakeholders
- Certified Medical Publication Professional (CMPP) or intention to achieve the certification within one year of hire
- Proven ability to build, forecast, track and manage budgets
2
Associate / Medical Director Job Description
Job Description Example
Our company is searching for experienced candidates for the position of associate / medical director. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for associate / medical director
- Drive and implement best practices in Medical Communications activities/initiatives
- Coordinates meetings to discuss conflicting comments on manuscripts
- Assists in the management of medical communications agency
- Provides managerial oversight to staff members, including performance assessment, training and feedback, resolution of personnel issues, and management of talent retention
- Implement systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure, and guarantee quality
- Manage and leads the US Ophthalmic MSL team to ensure proper execution and training
- Develops a training framework and materials for the MSL to optimally prepare the team for KOL interactions and relationship development
- Ensure US team is operating in an efficient, ethical and compliant manner
- Responsible for performance management for guidance and feedback (both formal and informal) throughout the year
- Interact with healthcare providers and thought leaders to communicate and advance the scientific platform as aligned with SUN Ophthalmic’s corporate goals and objectives
Qualifications for associate / medical director
- Familiarity with thought leaders in the field of psychiatry, particularly schizophrenia
- Must possess an active, unrestricted medical license to practice medicine or a health profession
- Active,unrestricted medical license to practice medicine in ta US state required
- Must possess an active unrestricted medical license to practice medicine in the State of Nevada
- Must possess an active unrestricted medical license to practice medicine in the State of California
- Current ABMS Certification required
3
Associate / Medical Director Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of associate / medical director. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for associate / medical director
- Serve as a supplementary medical knowledge resource when needed by providing clinically cogent and evidence based interpretation, recommendations and critiques on clinical matters of interest to Health Support leadership that assist in the direction and development of clinical product and services
- Responsible for the planning, preparation, writing, reviewing, editing, formatting, and finalizing of clinical and regulatory documents and publications for marketed products and compounds in development, under the direction of senior writers
- Perform peer review of various clinical or regulatory documents
- Support the development of clinical and regulatory submission strategies
- Be involved with process development and process improvement initiatives within the Clinical and Regulatory Departments and throughout the organization
- Assists Regulatory in the compilation and review of annual reports and progress reports to the FDA
- Budget, write and reviews proposals or portions of proposals for all phases of clinical studies whether it be premarketing or postmarketing
- Development, sustenance and demonstration of a medical affairs organization that provides expected services of the highest quality with respect to clinical knowledge, competence, judgment, operational effectiveness that reflects positively on the company and its mission to develop and provide pharmacy benefit management products, services and programs that deliver improved healthcare value and outcomes to clients
- Attendance, and active participation in, and the Pharmacy and Therapeutics (P&T) Committee meetings and the P&T process in their effort to identify and validate clinical value in drugs and therapeutics and appropriate formulary placement and applicable utilization management
- Maintain all licenses professional licenses, certifications, and credentials required to demonstrate clinical competency
Qualifications for associate / medical director
- Knowledge or aptitude for understanding clinical research terminology
- Ability to plan produce, and contribute to or review a Clinical Study Report according to ICH guidelines
- Ability to communicate with many professionals from many functional disciplines
- Ability to create and use graphs and tables optimally to convey key information
- Ability to assure consistency of medical documents to avoid confusion
- Competency in relevant software applications used in medical writing
4
Associate / Medical Director Job Description
Job Description Example
Our growing company is searching for experienced candidates for the position of associate / medical director. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for associate / medical director
- Participate in both internal and external project team meetings and liaise directly with clients on a variety of content aspects, including decisions on content strategy, revisions to reflect input from Marketing team and other stakeholders, and Medical Legal Regulatory reviews
- Providing medical expertise into project and study teams to successfully deliver clinical studies in Ph2/3
- Provides medical writing support for development of documents
- Oversees external medical writing vendors and statistical programmers
- Works effectively in a highly cross-functional environment
- Establishes relationships with healthcare professionals/authors/investigators
- Prepares for and responds to client medical audit programs
- Designs and directs medical toxicology and emergency response training and drills for Health Services personnel and assigned research staff
- Works with local hospitals and first responders
- Research options to effectively penetrate this new market by using the Voice Of the Customer (VOC) to provide market insights on product acceptance/ expectations, content platform preferences, decision-making/ influencing personas, and industry feedback through win/ loss assessments, advisory boards, focus groups, community management
Qualifications for associate / medical director
- Must possess the ability to lead with confidence
- A strong business orientation and acumen is desirable
- BS/BA minimum
- Relevant professional certification/credential (e.g., CMPP, AMWA) is a plus
- 5 years of medical/scientific publications (or related) experience required
- Pharmaceutical industry or related (e.g., medical communication agency) experience required
5
Associate / Medical Director Job Description
Job Description Example
Our company is looking for an associate / medical director. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for associate / medical director
- Participate as a member of the CMDM multidisciplinary team
- Actively manage projects and/or participate on project teams that require a physician subject matter expert
- Assist with quality control, formatting, and/or submission of documents and publications
- Serve as a Medical Writing representative on selected project teams and advise such teams on content, format, and style-guide requirements for documents
- Support coordination of writing activities of internal and contracted medical writing resources for project teams including timelines and document review/revision responsibilities
- To ensure compliance, the individual will remain informed on regulations and developments in medical writing, maintain knowledge of product areas, current trends, and current literature
- Drive data generation studies/projects to enhance medical-scientific knowledge in the TA(s)
- Earn and sustain trust through transparent collaboration with health care professionals, patient association representatives and HTA/reimbursement stakeholders
- Develop and execute the country Medical plan(s), support International in strategy considerations, planning and development with expert local knowledge
- Pro-actively collaborate in cross-functional teams
Qualifications for associate / medical director
- Advanced degree (PharmD, MD, PhD) with a minimum of 5 years experience in a headquarter-based role in Medical Affairs
- Knowledgeable about regulatory requirements for medical affairs activities
- Advanced degree in the life sciences (PharmD, RN, PhD, MD)
- Prior corporate experience in hematology/oncology therapeutic area is highly preferred
- Prior experience in Medical Information and reference database management is preferred
- Ability to drive to or fly to various meetings