Associate Director, Medical Resume Sample
Obie Rohan
8361 Johnston Mountain,
Los Angeles,
CA
+1 (555) 337 7837
Work Experience
Associate Director, Medical Writing
07/2017
-
PRESENT
Los Angeles, CA
- Ensures that the employees of the medical affairs department of the Nordic organization are in compliance with the rules and regulations of regulatory agencies (not limited to drug safety) and that company policies and procedures are being followed
- If applicable, manages respiratory resources: (a) Personnel – to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance; (b) budget – to ensure alignment with functional objectives, resource allocation and fiscal goals; Develops and updates related departmental SOPs and work-streams - 10%
- Process development & optimization
- Continuous gap analysis complying with local and regional/global policies
- Development and monitoring of metrics/KPI’s to measure & improve medical activities
- Generation of planning tools (MSL Plan, FTE allocation, …) and management reports (e.g. project tracker, monthly reports, …)
- Consistently ensuring a seamless crossfunctional interface (Medical, Marketing&Sales, Market Access, PV; GCO and Regulatory, )
- SOP & Working practice development
- Coordination of medical process trainings
Associate Director, Medical Information
12/2013
-
03/2017
Dallas, TX
- Coordination of seamless inspections/audits
- Study and publication management
- Ensuring compliance with local and global policies
- Supporting study implementation (conduct of due diligence of CRO selection, serving as primary contact for CRO during the study)
- Tracking and monitoring of study activities, provide regular updates on study progress
- Coordinating publication management
- Tracking and archiving publications
- Establishing and maintaining of tools to understand time needed for individual activities
Associate Director Medical Information
05/2008
-
11/2013
Phoenix, AZ
- Definition of time needed to perform individual tasks based upon industry experience
- Evaluating time allocation for top projects of company
- Challenging resource needs on a regular basis
- Alignment with global medical information process
- Oversight and adjustment of medical budget according to IPP aligning continously medical units and finance department
- Coordination of Medical and IPP planning process
- Development of local strategies for Medical aligned with global/regional strategies
- Development and implementation of new digital communication channels
- Interfaces with Therapeutic Area Heads, Clinical Program Directors, Biostatistics and Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process
Education
Grand View University
2004 - 2008
Science's Degree in Life Sciences
Professional Skills
- 3-5 yrs of demonstrated managerial skills in both direct and matrix reporting structures, including management of agencies and/or direct reports
- Think strategically; demonstrated negotiating skills and resourcefulness
- Strong influencing skills, able to lead without formal authority
- Experienced in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers
- Well-organized with a strong sense of urgency and standard of quality; ability to prioritize tasks and work simultaneously on multiple projects
- Experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers
- Proven creative problem solving and understanding of customer needs is highly desired
How to write Associate Director, Medical Resume
Associate Director, Medical role is responsible for administrative, training, database, planning, reporting, design, education, research, digital, travel.
To write great resume for associate director, medical job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Associate Director, Medical Resume
The section contact information is important in your associate director, medical resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Associate Director, Medical Resume
The section work experience is an essential part of your associate director, medical resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous associate director, medical responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular associate director, medical position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Associate Director, Medical resume experience can include:
- Excellent organizational skills; excellent attention to detail
- Effectively manages budget and resources (vendors and agencies) to meet short- and long-term objectives
- Relevant industry experience with at least 3 years in a medical information role
- Highly motivated to function proactively, operate with a sense of urgency, and bring tasks to completion
- 5+/8+ years of experience in the industry
- Demonstrates an entrepreneurial energy and enthusiasm which brings a positive approach to all challenges and fosters the idea that nothing is impossible
Education on an Associate Director, Medical Resume
Make sure to make education a priority on your associate director, medical resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your associate director, medical experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Associate Director, Medical Resume
When listing skills on your associate director, medical resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical associate director, medical skills:
- Positive and proactive communication skills, including effective meeting planning and management
- Independently motivated with good problem-solving ability and excellent attention to detail
- Proven successful experience working in a high-paced, multidisciplinary, pharmaceutical environment
- Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages
- Experience in selecting, contracting, and managing contract writers/ writing vendors
- Experience in managing junior colleagues, including supporting their career development
List of Typical Experience For an Associate Director, Medical Resume
1
Experience For Associate Director, Medical Writing Resume
- Excellent project management skills, with emphasis on time management and timelines, and administrative skills
- Establish excellent internal and external relationships; including alliance partners and vendors
- Experience with adult and pediatric clinical research in various therapeutic areas
- Work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands
- Establish excellent internal and external relationships, including alliance partners and vendors
- Demonstrated capability to accurately present clinical study data within the context of a specific type of clinical document
- Providing training and guidance on Disclosure and Drug Safety/PV medical writing best practices
2
Experience For Associate Director, Medical Information Resume
- Leading medical writing vendor selection, contracting, and management
- Serving as the Medical Writing Lead for one or more Amicus clinical development programs
- Leads cross-functional teams to develop a messaging strategy across a program of work (ie, building a clinical submission or a data disclosure plan)
- Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency
- Critiques ability of product strategy (ie, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed
- Significant understanding of medical and scientific principals relating to human health
- Significant understanding of the U.S. healthcare regulatory environment relating to medical practice and the pharmaceutical industry
3
Experience For Associate Director, Medical Operations Resume
- Within assigned programs, developing a comprehensive understanding of study designs, objectives, analysis plans, and results
- Limits corporate liability by meeting the medical ethical and legal responsibilities of providing product/device related information
- Act as Lead Medical Writer at Project level in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
- Represent Medical Writing on cross-functional clinical teams and actively participate in NDA submission planning and documentation
- The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
- Thrives in a multidisciplinary team setting
- Adept at searching multiple medical literature databases (PubMed, Embase, ScienceDirect, etc.), MS Word (advanced/expert), PowerPoint (familiarity)
- Fast learner and ability to work independently while seeking advice as required
4
Experience For Associate Director Medical Information Resume
- High level of flexibility and ability to innovate and adapt to changing conditions
- Contributes to interdepartmental projects, and supports the provision of medical, scientific and technical information regarding Otsuka products
- Supports development and implementation of strategy for writing and completion of high quality clinical documents
- Management in planning and preparation of clinical and regulatory documents
- Manage the annual planning process for Medical Affairs
- Contributes to MI planning and preparation activities for new product launches, line extensions, and key data releases,
5
Experience For Associate Director Medical Clinical Operations Resume
- Ensure compliance with Novartis systems & SOP’s and Sunshine, CIA and Anti-bribery
- Directs and coordinates the activities of the Medical Information Manager in the Nordic region
- Hire, and mentor subordinates to ensure the goals of the organization are met. Conduct performance reviews and ensure personal and professional growth of subordinate(s)
- Is dedicated to improve the support the Medical Department gives to all functions of the local affiliate
- Coordinate with Global Medical Teams to define and develop medical information materials (e.g. Standard Response Letters, Frequently Asked Questions, AMCP Dossier)
- Responsible for ensuring accuracy and completeness of Americas’ Hub unsolicited Medical Responses as well as ensuring all Adverse Events and Product Quality Complaints are identified and reported per Country regulations
- Supports maintenance, knowledge transfer, and as needed development of Merck’s Device specific Quality Management System
- Recognized subject matter expert for one or more therapeutic areas (TAs) and all products related to that business unit; a key internal contact for stakeholders who guides, influences and convinces others and communicates complex concepts with ease
6
Experience For Associate Director, Medical Devices Resume
- Hires, mentors and develops Medical Information staff; establishes goals and performance metrics for and oversees performance and career development of staff; guides and supports staff for project-related matters and sharing of best practice
- Develops regular and ad hoc metric and update reports for upper management and presentations within the organization; drives awareness and visibility of the US Medical Information department
- Acts as primary peer reviewer for USMI internal review process
- Develops Medical, Development, and Commercial relationships that provide valuable medical information knowledge and expertise sharing and participates in key meetings (e.g. congresses, scientific and medical meetings, and sales meetings) and business initiatives for assigned TA(s)
- Manages the launch of new product(s) by representing US Medical Information on product launch teams, ensuring departmental readiness for launch of a new product
- With a focus on assigned TA(s), directs the response to internal requests for medical information including ad hoc requests, project-based requests, and requests to support congress booths; tracks requests for metric reporting purposes
- Supports Medical Affairs booths for priority scientific meetings and provides scientific data as requested
- Follows regulatory guidelines and Standard Operating Procedures (SOPs) pertaining to Medical Information, documentation and dissemination of information
7
Experience For Associate Director Medical Resume
- Directs and participates in the development and maintenance of SOPs and job aids governing daily medical information practices at EMD Serono
- Interfaces with Global Medical Information colleagues to exchange medical information and best practices
- Monitor and manage Medical Information (MI) management process, vendors, and Medical Affairs programs/projects
- Serve as liaison and partner between Medical Information and internal business partners including HEOR, Quality, Pharmacovigilance, Market Access, Legal, Regulatory, Compliance, Information Technology and other relevant functions in the organization as needed
- Develop and maintain up-to-date medical documents, including medical content letters, FAQs, Dossiers, etc., for all Ferring products
- Provide periodic reporting and ad hoc query results to internal Business units
- Set the policies and directions for activities to be conducted by the Medical Information Call Center (MICC)
- Develop and execute internal and MICC product, disease state and medical content documents training to ensure Ferring personnel are equipped to handle questions and responses associated with all Ferring products
- Create and manage Medical Affairs related SOPs and ensure compliance with internal/external regulations
8
Experience For Associate Director Medical Devices Combination Product Capa Resume
- Evaluate published medical and scientific literature on Ferring and competitive products; review internal/external literature to stay abreast of med/market trends
- Communicate information gathered and researched from various sources to appropriate internal functions and roles
- Maintain and up-date the internal Medical Affairs SharePoint site
- Analyze medical information metrics and generate content based on trends and share appropriately with management
- Assist in development and facilitate review of internal/field medical affairs slides decks and materials
- Management of pharmacy preceptorship programs and patient adherence programs
- Participate in Legal Medical Regulatory review committee and facilitation of Medical Affairs initiated projects when necessary
- Responsibilities, focused on the assigned program(s), include but are not limited to
- Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures
9
Experience For Associate Director Medical Contact Center Ops Resume
- Contributing to clinical development team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
- Lead process improvement initiatives and development strategies to optimize medical information policies and procedures towards global alignment
- Utilize expertise and functional knowledge of the literature to collaboratively and effectively work within cross-functional teams to provide scientific input into the development strategy of YESCARTA and Kite’s investigational therapies
- Represent Kite at major scientific meetings and conferences
- Performing document-specific tasks such as (a) serving as a key reviewer of statistical analysis plans and accompanying table and listing shells, (b) ensuring editorial review of documents (grammar, punctuation, and formatting), and (c) ensuring quality-checking of documents (including for submission-ready formatting)
- Ensuring compliance with templates and standard operating procedures (SOPs) and applying the principle of continuous improvement to all in-house and contracted medical writing procedures for safety and disclosure
- Contributing to cross-functional team meetings, with a focus on resolving issues related to regulatory document planning, development, and approval
- Provides medical expertise to both internal team and to clients in wide range of therapeutic areas for products and brands in atopic dermatitis and asthma
10
Experience For Associate Director Medical & Clinical Operations Resume
- Coordinates the tasks of medical information and health economics and outcomes research in producing a formulary submission dossier and maintains/updates as new information becomes available
- Develops and maintains high quality medical response documents to answer unsolicited product inquires from external healthcare professionals and patients/care givers
- Provides product medical communication expertise to internal colleagues
- Provides product support and necessary guidance to Medical Information Call Center colleagues
- Provides scientific and medical review of product promotional materials
- Provides product and literature updates to medical affairs product team and extended product team as necessary
List of Typical Skills For an Associate Director, Medical Resume
1
Skills For Associate Director, Medical Writing Resume
- Advanced computer skills necessary
- 7 – 10 years of experience in medical and regulatory writing and in managing CROs/consultants (contractors)
- Progressive experience in medical writing, including oversight/management of permanent and contract staff or CROs
- Regulatory writing and management experience
- Experience working in relevant therapeutic areas
2
Skills For Associate Director, Medical Information Resume
- Demonstrated collaborative and cross-functional approach to delivering functional results
- General understanding of medical affairs activities and the regulatory environment in which we operate
- Experience working across matrix organization / cross-functionally
- An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP)
- Industry experience as Medical Writer
- Demonstrated ability to manage a large number of complex projects simultaneously
- Managing, leading, and/or assisting more junior writers and other medical writing-related staff (including contract or CRO staff)
- Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the medical writing community)
- Eading medical writing vendor selection, contracting, and management
3
Skills For Associate Director, Medical Operations Resume
- Providing training and guidance on medical writing best practices
- Leading Disclosure and Drug Safety/PV medical writing vendor selection, contracting, and management
- Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems
- Serving as the Medical Writing Lead
- Ensuring that documents are appropriate for their target audience while also meeting all regulatory requirements
- Developing a comprehensive understanding of study designs, objectives, analyses plans, and results
4
Skills For Associate Director Medical Information Resume
- Participating in departmental oversight, including projection of annual budget and resource needs
- Serving as the Disclosure and Drug Safety/PV Medical Writing Lead
- Planning and conducting cross-functional meetings
- Working with Regulatory Clinical Lead, prepares Regulatory Development Strategy for regulatory development projects
- Collaborating with subject matter experts across other Amicus functions
- Participating in projection of annual budget and resource needs for Disclosure and Drug Safety/PV medical writing
- Serving as the Disclosureand Drug Safety/PV Medical Writing Lead
- Ensuring that documents prepared are appropriate for their target audience while also meeting all regulatory requirements
5
Skills For Associate Director Medical Clinical Operations Resume
- Writing Clinical study reports
- Keeping informed of new regulations and/or guidance from regulatory authorities
- Plan and manage core Medical Affairs team activities including team meetings, strategic planning, off-sites, and team building
- Program forecasting, budgeting, and provides support to MWD management in resource planning
- Conduct on-going training to Pacira personnel and speakers as needed
- Successful track record of leading complex clinical / regulatory writing projects
- Contributes to establishing and building the medical organization in Nordic region
6
Skills For Associate Director, Medical Devices Resume
- Management of Kite Pharma’s centralized medical information database including document access, tracking, storage and retrieval
- Serve as expert in therapeutic areas covered by Ferring products and attend medical/scientific meetings/conventions as a Ferring Medical Affairs representative
- Knowledgeable of applicable regulations regarding dissemination of medical information, drug promotion, and adverse event/product complaint reporting
- Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents
- Flexible and willing to take on a variety of responsibilities as the needs of the Medical Affairs team grow and evolve
7
Skills For Associate Director Medical Resume
- Familiarity with research tools and approaches, such as reference management/publication planning databases
- Thorough knowledge of drug development, registration and marketing process
- Sets specific goals for the Medical Information Manager, meeting the overall goals of the organization in the Nordic region
- Participate in new systems implementations and ongoing maintenance of current systems to improve efficiency
- Learn on the fly/ quickly identifies what’s important and what’s not
- Is highly involved in the development and management of IIT’s
- Responsible for establishing strategies for document authoring, contributing strategically and scientifically at the project and/or study team level, managing vendors and external writers with regard to document quality, and developing regulatory writing timelines, processes, and working standards
- Can independently serve as the lead writer for regulatory submission documents such as eCTD module 2, 3, and 4 summaries, meeting briefing documents, and other documents as needed
8
Skills For Associate Director Medical Devices Combination Product Capa Resume
- Working with Regulatory Clinical or CMC Lead, determines document authoring resource needs, proactively identifies issues and solutions, and sets timelines and processes
- Writes regulatory documents in compliance with company standard operating procedures (SOPs) and applicable health authority guidance and regulations
- Ensures key messages are clear and consistent within and across documents
- Contributes strategically and scientifically at the project team level
- Contributes to formation of key messages in consultation with functional area experts
- Manages vendors and external writers with regard to document quality; provides guidance to external writers on company standards and style and industry best practices for regulatory writing
- Develops regulatory writing timelines, processes, and working standards; ensures company SOPs, templates, style guides, etc, are aligned with industry best practices
- Contributes interdepartmentally to Clinical/Medical, Drug Safety, and R&D departments as needed
9
Skills For Associate Director Medical Contact Center Ops Resume
- Provide management support for activities with outside vendors and business partners, as required
- Critically review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency
- Act as liaison between internal and external reviewers and the external writer
- Organize and lead cross-functional meetings
- Participate in appropriate development teams and internal strategy and operations meetings
- Develops, updates and reviews relevant, unbiased medical information response documents and product profiles that are provided to customers and ensures content represents the most current, complete, medically accurate, evidence-based and scientifically balanced information
- Utilizes the appropriate information resources to identify published literature and respond to medical information inquiries from healthcare professionals, consumers, and internal business partners verbally and/or in writing; prepares customized responses as needed
- Proactively develop and/or create medical response documents as well as revise and/or update existing documents in the database
- Conduct literature searches and critically evaluate results to respond to escalated external inquiries as well as internal business partner inquiries. Respond to field personnel or other internal and external customers on medical information requests in a timely manner
10
Skills For Associate Director Medical & Clinical Operations Resume
- Critically evaluate published medical and scientific literature on Pacira products and competitive products; review internal/external literature to stay abreast of med/market trends and provide the appropriate training to Pacira colleagues
- Perform multiple tasks and prioritise work effectively
- Experience as a medical writer in the sponsor/CRO setting
- Experience developing responses to scientific inquiries from healthcare professionals and/or consumers is required
- Health plan or clinical care management with progressive operational experience
- Experienced in the use of Documentum
List of Typical Responsibilities For an Associate Director, Medical Resume
1
Responsibilities For Associate Director, Medical Writing Resume
- Provide direction to medical writing team and monitor outputs, ensuring quality, compliance, appropriateness and profitability
- Regulatory marketing application of NDA & MAA
- Agile learner with ability to work both collaboratively or independently, seeking advice as required
- Ensure that Medical Affairs remains an integrated, coordinated, and high-functioning team as we grow
- Knowledge of medical communications business objectives, services and operating procedures
- Maintains core product reference literature, as well as, necessary key competitor and disease literature references
- Maintains Product Scientific Q&A
2
Responsibilities For Associate Director, Medical Information Resume
- Stays current with competitor products and with advances in medical therapies in assigned therapeutic area
- Strict adherence to departmental, corporate, and regulatory compliance standards
- As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management
- Leads the medical writing activities for marketing application submission documents (eg, NDA, MAA)
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines is essential
- Well-developed sense of ethics, responsibility and respect for others
- Results-driven and sets standard of excellence for self and others
- Compose, revise in response to team feedback, and deliver submission-ready documents (eg, key clinical study protocols, briefing documents, overall summary documents)
- Manage, lead, and/or assist more junior writers and other medical writing-related staff (including contract or CRO staff)
3
Responsibilities For Associate Director, Medical Operations Resume
- Provide detailed, accurate, and timely reviews of documents prepared by others (eg, Statistical Analysis Plans, Clinical Study Reports, Investigator Brochure Updates, Developmental or Periodic Safety Update Reports)
- Ensuring compliance in regard to use of document templates and following standard operating procedures (SOPs), including applying the principle of continuous improvement to all in-house and contracted medical writing procedures
- Building and maintaining collaborative relationships with medical writing partners (contract and FTE employees, CROs, and the overall medical writing community)
- Contributing to medical writing vendor selection, contracting, and management
- Provides strategic direction in developing/maintaining a current and comprehensive medical response database
- Provides guidance to other medical information personnel on appropriate searching, review and interpretation of scientific data
- Participates in the approval process for custom and standard inquiry responses to assure that all responses for a given brand are accurate, relevant and timely
- Remains current on all published and ongoing data for a given brand and subsequently performs a critical analysis to determine relevance of that data for inclusion into standard medical responses
4
Responsibilities For Associate Director Medical Information Resume
- Provides product training to the contact center and collaborates with the contact center as needed for a specific brand
- Assists in the development/enhancement and implementation of policies, procedures, and processes for the department
- Develop/maintain metrics on Otsuka products to monitor Medical Information inquiries
- Assist in the management of medical information vendors/consultants
- Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
- Receives, documents, and responds to written medical information requests
- Evaluates, analyzes, and responds to issues in an accurate, balanced, and timely manner according to Product Information and Corporate Standard Operating Procedures (SOP)
5
Responsibilities For Associate Director Medical Clinical Operations Resume
- Recognizes and gathers, according to FDA guidelines and company policies, initial information regarding any adverse events or product complaint reports of which made aware during the handling of medical information and medical device inquiries
- Attends external medical conferences to represent Otsuka Pharmaceutical Development & Commercialization, Inc and staffs the Medical Information Booth as needed
- Actively supports clinical project team(s), representing MW, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary
- Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues
- Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects
- Experience desired in MW for rare diseases and capability to develop and implement innovative solutions for optimizing MW for rare disease studiesDemonstrated writing capability for clinical study documents, (eg, clinical study protocols and clinical study reports, Investigator’s Brochures)
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines
6
Responsibilities For Associate Director, Medical Devices Resume
- Team player who thrives in a team-based environment
- Well-developed sense of ethics, responsibility, and respect for others
- Results- and compliance-driven; sets standard of excellence for self and others
- Coordinate with various functional areas in Clinical Development and Medical Affairs, Regulatory, and Project
- Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
- Mentor junior Medical Writers
- Manage budgets and contracting for a variety of Medical Affairs activities, including medical education, grants, sponsored research, advisory boards, medical congresses, and publications
- Work with AMAG Program Management, Administrative, IT, Facilities, HR, etc. as needed to ensure smooth operations across Medical Affairs
7
Responsibilities For Associate Director Medical Resume
- Facilitate key Medical Affairs activities around publications (author disclosures, reference library management, abstract submissions), medical congresses (medical booth planning, sponsorships, planning and logistics), sponsored research (Scientific Review Committee and contracting), and advisory boards
- Identify technical needs and work with IT to evaluate and implement software solutions as group needs evolve
- Ensure that Medical Affairs team members are trained on all relevant SOPs and that Medical Affairs activities are conducted in a compliant manner
- Collaboration and strategic partnership with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives
- Building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship (defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables)
8
Responsibilities For Associate Director Medical Devices Combination Product Capa Resume
- Exceptional English language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
- Min 6 years’ experience (in larger affiliates 6+ years) within a medical affairs role in
- Demonstrated ability to conduct literature analysis is required
- Experience with ultra-rare disease and Orphan Drug clinical research is highly desirable
- Experience in a pharmaceutical, medical device, or biotech company
- Experience in project management or operational management
- Able to demonstrate exceptional follow-through on tasks and projects
- 8-10 yrs of experience in similar role or function
- Experience in pharmaceutical industry and within a Medical Information and Communications function required
9
Responsibilities For Associate Director Medical Contact Center Ops Resume
- Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
- Shown strength in Microsoft Office programs (Word, Excel, and PowerPoint) is required
- Expert knowledge of standard clinical regulatory document types
- Master’s (Scientific), PhD, or PharmD
- Thorough knowledge of Good Publications Practices (GPP2) and Guidelines for Authorship of the International Congress of Medical Journal Editors (ICMJE 1997 Vancouver Criteria)
- Familiar with style rules from the American Association Manual of Style
- Mastery of medical terminology and medical literature
10
Responsibilities For Associate Director Medical & Clinical Operations Resume
- Thorough understanding of regulatory authorities, legal, and industry guidelines and requirements related to the practice of medical and drug information in the pharmaceutical/biotech industry
- Experience across most types of regulatory medical writing deliverables
- Demonstrated ability to independently make and execute strategic decisions, based on quickly digesting and assimilating pertinent information, and including leading cross-functional teams through execution
- Demonstrated ability totranslate technical information from mixed sources into written information suitable for an audience of clinicians and regulatory authorities while summarizing data that enables reaching conclusions and exercising judgment to move projects forward
- Training in the biomedical sciences, as well as experience in technical written communication and working cross-functionally, including with partner companies and vendors
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