Manager, Medical Affairs Resume Sample
Sarah Shields
4737 Sydnee Villages,
Boston,
MA
+1 (555) 990 1103
Work Experience
Manager, Medical Affairs
05/2018
-
PRESENT
Houston, TX
- Contributes to the ongoing development of Genentech’s Project Team System; including sharing best practices, lessons learned, identifying cross-project opportunities, dependencies and efficiencies
- Medical Affairs partners in therapeutic area
- Clinical Research and Development
- Makes decisions independently Internal and external interaction mainly requires interpretation of complex information Adhere to timelines and deadlines Effective communicate with management, customers and colleagues Complete assigned job tasks and responsibilities in an efficient manner
- Serve as an acknowledged expert on company’s products and related competitive products in all areas relevant to internal and external customers: clinical, scientific, technical and health economics
- Respond to data inquiries from internal stakeholders
- Provide product training to internal stakeholders (e.g., sales, market access, medical) as needed
- Respond to escalated Medical Information inquiries as needed
Senior Manager, Medical Affairs
01/2014
-
01/2018
Detroit, MI
- Maintenance of AMCP dossier
- Track product publication plans including reviewing, editing, and authoring of scientific/medical publications as needed. Liaise with external authors and handle internal review process
- Researching, evaluating and becoming Subject Matter Expert (SME) in assigned processes
- Researching and implementing measures to streamline processes
- Establishing process protocol and related communication
- Training new hires on applicable processes and monitoring progress
- Re-training current staff on applicable processes when necessary
- The Associate MAF Manager’s mission is to support the quality use of our medicines through clinically relevant and scientifically robust interactions with leading specialists as a trusted scientific counterpart
- Oversees product development including clinical appropriateness reviews
Senior Manager, Medical Affairs Operations
06/2008
-
12/2013
San Francisco, CA
- Coordinating execution of the Nusinersen NPP. Evaluating possibilities to open EAPs in the Region
- Providing medical training and medical project support primarily to partner companies/ Biogen affiliates in the region including support to Market Access, PAG management, Marketing,
- Visiting SMA Leading Experts (at least 20% travel)
- Partners with Complaint Handling, Safety Vigilance, and Regulatory groups to support appropriate reporting of adverse events to FDA, competent authorities and regulators. Evaluate and investigate of the complaint process. Confirm awareness date for serious injuries
- Receive clinical input from QA clinicians and determine reportability of subject codes/product malfunctions, consequence codes, adverse events, probability & likelihood, and assist in the rationale in the Hazards List
- Ensure consistent medical evaluation of complaints to determine reportable events
- Coordinate complaints received through non-standard channels, such as verbal communications, clinical evaluations, literature and publications, etc
Education
Towson University
2002 - 2007
Bachelor's Degree in Clinical
Professional Skills
- Strong interpersonal skills; good listening skills
- Strong influencing skills and demonstrated ability to create and lead successful cross-functional teams in changing, competitive environments
- Self starter with strong problem solving skills and operational experience
- Demonstrated business planning ability and strong organizational skills
- Excellent scientific writing skills and experiences
- Strong meeting facilitation skills and experiences
- Excellent interpersonal skills and ability to communicate effectively with people in different functions
How to write Manager, Medical Affairs Resume
Manager, Medical Affairs role is responsible for interpersonal, regulatory, software, health, finance, training, integration, database, mac, oncology.
To write great resume for manager, medical affairs job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Manager, Medical Affairs Resume
The section contact information is important in your manager, medical affairs 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 Manager, Medical Affairs Resume
The section work experience is an essential part of your manager, medical affairs 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 manager, medical affairs responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular manager, medical affairs position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Manager, Medical Affairs resume experience can include:
- Strong organizational skills with ability to multi-task and manage multiple projects in parallel
- Demonstrated interpersonal skills to successfully partner with individuals to build relationships with business contacts, customers, and regulatory entities
- Experience in clinical research, clinical coordinator, clinical nurse role or an equivalent combination of education and experience
- Able to demonstrate innovation, Teamwork and accountability in prior roles
- Understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders
- Tracking implementation and quality of skill upgradation programs, and other scientific initiatives
Education on a Manager, Medical Affairs Resume
Make sure to make education a priority on your manager, medical affairs resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your manager, medical affairs 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 Manager, Medical Affairs Resume
When listing skills on your manager, medical affairs 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 manager, medical affairs skills:
- Good listening skills and a strong willingness/desire to help resolve issues faced by others around them
- Strong analytical, problem-solving, and scientific writing skills
- Strong strategic, problem-solving skills
- Excellent interpersonal coordination and communication skills
- Possesses a collaborative, results-driven style with strong interpersonal and communication skills
- Advanced skills in working with PowerPoint, Word, Excel, and other communication mediums
List of Typical Experience For a Manager, Medical Affairs Resume
1
Experience For Senior Manager, Medical Affairs Resume
- Develop people talent and professional skills
- Recent or ongoing work in a clinical position is desirable, as is experience in teaching/in-servicing other health care professionals
- Develop clinical plans and protocols for new and existing products through strong cross-organizational collaboration & understanding of business needs
- Pursues integration of clinical teams into an effective departmental collaboration and strives to avoid communication deficiencies and related “silo” formation
- Independently review raw and summary data and conduct periodic validations of database for accuracy
- Lead effort to develop internal and external surveys to evaluate team effectiveness
- Experience in Medical Affairs role
2
Experience For Associate Manager, Medical Affairs Resume
- Creating Business Solutions
- Ensure application of key learning’s across assigned brands, ensuring alignment of development and commercial objectives
- Provide clinical expertise for the creation and development of training programs that support sales and marketing efforts
- Provide a broad range of support for new launching countries as required eg training, advisory board support, Market access activity
- Acts as a medical resource for the company working with, marketing, medical and clinical research departments
- Liaison with external investigators and study groups in managing study collaborations
- With limited supervision, recommend appropriate actions for proposed advertising and promotion sometimes with little or no precedent
- Act as a designee (of the Medical Director) in medical safety processes
- Establishes and maintains good and effective working relationships with the Company’s Medical Director, clinicians, scientists, core-labs, clinical consultants, and internal clients
3
Experience For Senior Manager, Medical Affairs Operations Resume
- Key role in compliance & ethics, maintains good relationships with internal and external compliance partners. Ensures a professional clinical approach which is in compliance with highest ethical and scientific standards in which patient safety and data accuracy are put first and considered as the highest goods
- Participates in the development and review of clinical reports, for example clinical evaluation reports, periodical clinical updates, clinical justifications for regulatory filings, and slide presentations pertaining to Company’s clinical material
- Gives continuous input into and participates in the development and maintenance of processes and SOPs. Pro-actively identifies process and/or SOP-related obstacles to effective study conduct
- Write clinical protocols for a dynamic portfolio of selected studies across TMTT
- Partner with TMTT R&D, Clinical Affairs, Safety, Regulatory Affairs, QA, Biometrics, GHER and other subject matter experts to create documents and that effectively and clearly describe research results, product use and other medical information
- Ensure documents comply with regulatory guidelines
- Correctly analyze data/results and interpret outcomes to propose appropriate follow-up
- Provide support for review of IIS (investigator initiated studies)
4
Experience For Project Execution Manager, Medical Affairs Resume
- Up to 15% travel to conferences/physician meetings
- Partner with U.S. Medical Affairs leadership, R&D legal and compliance to identify operational and compliance risks, determine areas of support requied, and develop a comprehensive training and monitoring plan
- Leads projects to assess organizational needs, capacity management practices, identifies gaps, and proposes new processes and tools to improve planning and organizational effectiveness
- Lead trainings and educational activities to ensure U.S. Medical Affairs team understand and are compliant with all relevant policies and procedures (e.g. U.S. Operating Model, Global Medical Affairs policies and SOPs) as well as federal and local regulations
- Provide operational support to key medical activities related to HCP engagement such as advisory boards, medical roundtables, and scientific exchange visits, as well as patient support activities such as patient programs and patient insight reporting
- Collaborate with U.S. Medical Affairs leadership team to design and implement team building activities such as national and regional team meetings as needed
5
Experience For Senior Manager Medical Affairs Resume
- Collaborate with IT (ALEX 2.0 and other necessary system) to ensure compliant documentation of relevant medical activities
- Support U.S. Medical Affairs team to facilitate audits and inspections
- Work with U.S. Medical Affairs leadership team to design and lead key reports and/or dashboards
- Acting in concert with medical directors, and other internal stakeholders, serve as a liaison between the company and clinical investigators; develop credible relationships with internal functional leaders
- Manage review and oversight of IITs, support budget negotiations and contract development with clinical institutions and third party vendors
- Support the maintenance and update of the standard operating processes (SOPs) and WPs, under the direction of the MA Management, and promote adherence to the current processes
- In collaboration with therapeutic area responsible leads and Senior Director Global Medical Affairs Strategic Planning, facilitate development strategic IIT guidance documents/practices. Manage organizational logistics of IIT proposal intake, review, and tracking of decisions by franchise leads and the Internal Review Committee
- Support Senior Director Global Medical Affairs Strategic Planning and therapeutic area leaders with franchise clinical initiatives (program quality, tracking against financial targets, metrics/ timelines)
6
Experience For Manager, Medical Affairs Operations Resume
- Participate in process development activities for IITs and post-marketing clinical studies and participate in Lessons Learned session to improve existing practices
- Immunology therapeutic area experience is required
- Investigator Initiated trial experience is required
- BS/BA in a health-related science or RN
- Knowledge of drug development process, FDA, ICH, and GCP guidelines and HCC practice
7
Experience For Senior Manager, Medical Affairs, Immuno Resume
- Manage the operations of the US Investigator Sponsored Trials program for some of Jazz Pharmaceuticals therapeutic areas (currently Oncology, Sleep, and Pain). This includes but is not limited to
- Represents the company as member or (co)chair in external committees such as translational research committees for medical affairs trials
- Relevant country regulation, policy and Code of Practice
- CSL’s Code of Responsible Business Practice
- Interactions with Healthcare Professionals and Healthcare Organizations (POL-0013)
- Anti-Bribery and Anti-Corruption (POL-0400)
- Records Management Policy (POL-0133)
- The MSL Manager report directly to the Medical Affairs Director who is responsibility for one Therapeutic Franchise
8
Experience For Senior Business Manager, Medical Affairs Resume
- Under the responsibility of the Medical Affairs Director the MSL Manager manages the MSLs based and deployed in his/her region for one Therapeutic area to which he/her belongs
- In his/her region for his/her product/franchise he/she has the responsibility to
- Develop the scientific leadership in his /her Region
- Coordinate the execution of the Medical Affair plan with regional medical bodies ( Medical and Scientific Leaders - Health Care Professional) and with MSD regional stakeholders (Sales and Marketing)
- Align the activities with the franchise medical communication strategy
- Deliver the Medical Affairs Plan in a timely and efficient manner
- Propose to adapt the regional MAP and MSLs regional activities on the regional specificities and needs
- He/she is responsible of his/her team scientific leadership in the region
- He/she is responsible of the team's performance and qualitative impact
9
Experience For Manager, Medical Affairs & Credentialing Resume
- Be the scientific and medical expert about the disease and the product
- Give input in the franchise strategies and tactics
- Coordination of Medical memos/mailings/slide decks
- Medical Review of promotional and scientific material
- Competitive intelligence follow- up
- Present and defend local requests for grants towards the regional medical grant review committee
- Build a network with the international medical teams
- Coordination and follow-up of Medical need and compassionate use programs
10
Experience For Senior Manager, Medical Affairs SMA Resume
- Develop and maintain peer-to-peer collaborations and relationships with key medical experts in a relevant therapeutic area (Metabolics)
- Ensure compliance with Alexion policies
- Travel throughout Brazil and other countries for up 60-70 % of the time
- Review, edit, and manage renewals and amendments for agreements, contracts and protocols for medical affairs studies, working in close collaboration with the US and International Legal and Finance teams and external investigators
- Manage the US and International Medical Affairs Studies Teams (MAST) and processes for reviewing new study proposals and tracking operational progress, budgets, and milestones for ongoing studies
- Based on feedback from MAST review, work with GHI Medical Directors and external investigators to refine study protocol and budget to align with GHI resources and goals
- Experience in basic science and/or clinical research methodology desirable
- Manage the Medical Affairs Clinical Research Program meetings with a focus on possible issues related to compliance, finance, and the commercial portfolio
List of Typical Skills For a Manager, Medical Affairs Resume
1
Skills For Senior Manager, Medical Affairs Resume
- Demonstrates and models excellent performance in the Scientific Communications role
- Demonstrated customer focus and demonstrated ability to facilitate appropriate team decisions
- Proficiency in Microsoft PowerPoint, Excel, and Word software applications and over advance computer skills with knowledge of literature search techniques
- Experience in a medical role in industry. Ideally, medical/scientific experience in rare diseases
- Operational processes, health care compliance, regulatory requirements, as well as project management skills is required
- Organizational skills and enthusiasm for creativity
- Pharmaceutical industry experience in Medical Affairs or Clinical Development (+ 4 years’ experience) for renal products would also be considered
- Demonstrated ability to work independently, ability to prioritize and manage multiple tasks simultaneously
2
Skills For Associate Manager, Medical Affairs Resume
- An independent self-starter with the ability to work effectively both alone and with cross-functional teams
- Prior Pharmaceutical or Biotech industry experience (medical, clinical or specialty products expertise)
- Excellent in implementing assigned projects and acting as a role model (leading by example, leadership)
- Experience in the planning, conducting, and managing studies in a clinical program from study start-up to regulatory submission
- Support U.S. Medical Affairs leadership team in annual budget planning, forecasting, tracking, and resource prioritization
3
Skills For Senior Manager, Medical Affairs Operations Resume
- Positive experience in collaborating with sales and marketing people
- Team player, “can-do” attitude Ability and desire to develop good working relationships internally and externally
- Good Business needs understanding, customer focus and result oriented mindset
- Experienced with literature reviews and various publication databases including PubMed
- Experience and knowledge of clinical research programs including methodologies, processes, and timelines
- Experience working with clinical trials and/or within pharmaceutical environment required
- Experience as a clinical trial manager with accountability for managing study budgets, timelines and quality
4
Skills For Project Execution Manager, Medical Affairs Resume
- Proven ability to design and implement post-marketing trials
- Experience managing complex projects with team members in multiple locations
- Experience in Medico Marketing essential
- Serve as a Subject Matter Expert (SME) for developing valid clinical test protocols
- Previous experience working in Medical Affairs
- Strong work ethic and commitment to serve internal and external clients
- Demonstrated high level of personal integrity, emotional intelligence, flexibility
5
Skills For Senior Manager Medical Affairs Resume
- Clinical background, or extensive clinical research experience in the device or pharmaceutical industry
- Demonstrated ability to influence and persuade others
- MD, PhD, or PharmD with 5 years’ experience in Medical Affairs/Information field
- Strong scientific background in rheumatology with in depth knowledge of Rheumatoid Arthritis
- Cross-functional team experience in the pharmaceutical or diagnostics industries
- Proven track record of team work and project management
- Practice experience as a licensed registered nurse
- Clinical background, or extensive clinical research experience in in the device- or pharmaceutical industry
- Previous related experience in medical affairs
6
Skills For Manager, Medical Affairs Operations Resume
- Capability and good Ability to negotiate
- Experience in related field
- Clinical experience with medical devices and knowledge of clinical trial design,
- Strong cross-organizational collaboration with internal teams and external investigators or project partners
- Experience in therapy area is desirable
- Demonstrated ability to manage relationships with external experts
- Strong ability to interpret scientific data
7
Skills For Senior Manager, Medical Affairs, Immuno Resume
- Acts independently with good judgment, when needed
- Min 5 years’ experience in pharmaceutical Company
- Developing and performing quality controls on internal databases and documentation repositories under the direction of the MA Management
- Networking with key customers to identify opportunities for extending key initiatives
- Acting as an internal expert on FDA regulations governing the promotion of assigned products
- Understanding of biomarkers and clinical and molecular diagnostics
- Understanding of patient care and cardiovascular procedures
8
Skills For Senior Business Manager, Medical Affairs Resume
- Managing projects within budget
- Training of commercial/medical colleagues on diseases and treatments
- Understanding of commercialization process and clinical development. Knowledge of molecular biology, immunology and pharmacology
- Understanding the customer need
- Perform clinical research which includes data mining, compiling, analyzing and summarizing data from all applicable sources
- Proficiency in working with spreadsheets, Salesforce, data mining tools and project management software
- Lead planning, execution and reporting of key medical projects (e.g, Advisory Boards, communication events, Satellite Symposia, etc)
9
Skills For Manager, Medical Affairs & Credentialing Resume
- Compliance to promotional guidelines, product safety medical information flow and marketing team training
- Passion for science and teaching
- Attends key scientific conventions to obtain the most up to date medical scientific data (including competitive information)
- Reviews/approves advertising and promotional, as well as scientific and educational, materials within the therapeutic area
- Assess clinical results summarize into reports, assist in authoring reports and justifications
- Flexible, independent and fast working
- Advanced working knowledge with the use of MS PowerPoint, MS Word, MS Excel, EndNote and Adobe Acrobat
- Work independently & be self-motivating
- Exercises foresight and judgment in making complex decisions
10
Skills For Senior Manager, Medical Affairs SMA Resume
- Maintain current, in-depth product knowledge including current developments, clinical literature review, as well as therapeutic and product operation knowledge
- Support Medical Directors team operationally on annual strategic planning
- Ensure implementation and execution of BM strategies in global medical affairs studies and projects (including input and authorship for study protocols)
- Global Process to Handle Questions from External Healthcare Professionals “Global Q&A Process” Working Instructions Document
- Pharmacovigilance, including benefit-risk communication - manage appropriate project related PV activity implementation –
- Develop and maintain a network of leading medical clinicians (Key Opinion Leaders; KOLs)
- Co-ordinating with key customers both external and internal for execution
- Knowledge of medico marketing, conduct of phase IV clinical trials, GCP-ICH guidelines, regulatory processes
List of Typical Responsibilities For a Manager, Medical Affairs Resume
1
Responsibilities For Senior Manager, Medical Affairs Resume
- Manage Medical Affairs departmental budget for studies with the provision of monthly updates to Finance department in addition to maintaining routine communication regarding pending/new contracts and rates of study enrollment as they apply to milestone payments
- Facilitate communication between Accessioning, Pathology, Data Management, Genomic Sciences and Customer Service to streamline the initiation of studies, facilitate tracking of study milestones, troubleshooting issues with study orders and anticipating assay volume
- Demonstrates proficiency in developing scientific slide decks
- Preference given to persons with experience in the Dermatology and/or Rheumatology field
- Demonstrated ability to implement projects of strategic importance from conception to high quality deliverable
- Project management experience within the biopharma industry
2
Responsibilities For Associate Manager, Medical Affairs Resume
- Pharma or biotech experience
- Excellent relation with important KOLs in multiple therapy segments and different geographical locations
- Demonstrated ability in data analysis and scientific writing is required
- Solid knowledge of FDA regulations for medical communications
- Experience in the pharmaceutical environment required, ideally in Medical affairs
3
Responsibilities For Senior Manager, Medical Affairs Operations Resume
- Experience in clinical trials such as management or investigator is highly desirable
- Consultative support to MA project teams for issues/strategies relating to continuity between development plans and commercial objectives
- Advise on the development of US labeling to ensure support for anticipated promotional messages and claims
- Identify KOLs, establish and maintain contact, manage cooperation including conference presentations and publications
- Maintain close interactions with Scientific Communication Leads, Medical Directors, Training Leads, MSLs, Compliance, and other internal stakeholders
4
Responsibilities For Project Execution Manager, Medical Affairs Resume
- Knowledge of pharmaceutical industry regulations, guidelines, standards and practices, including GPP3, ICMJE guidelines
- Maintain a repository of study contracts, protocols, budgets, and key correspondences essential to the management of individual studies and study proposals
- Collaborate with the Clinical Operations and Development teams on an alignment of study processes and coordination of laboratory resources for study execution
- Provide and present periodic summary updates for the portfolio of medical affairs studies
- Operational support for Franchise Teams and Clinical Sub-Teams as needed
5
Responsibilities For Senior Manager Medical Affairs Resume
- Experience in project/program management in a scientific research setting. Specific experience in managing operations of clinical studies in an academic setting or within the pharmaceutical, medical device, or diagnostic industries strongly desirable
- Clinical work experience desirable
- Establish long-term medical-scientific/strategic relationships with key thought leaders and with related medical associations and academic centers of excellence
- Engage with thought leaders in scientific forums in relevant professional areas (i.e. society meetings, symposia, study groups, advisory boards, research conferences, etc)
- Conduct advisory boards and clinical study steering committees
6
Responsibilities For Manager, Medical Affairs Operations Resume
- Maintain company relationships with KOLs, academic centers, scientific societies, policy makers, and other organizations responsible for practice guideline recommendations
- Communicate relevant information from key thought leaders to key cross-functional partners
- Fluent written and spoken German, English, French
- Develop and maintain peer-to-peer collaborations and relationships with key medical experts in a relevant therapeutic area (Shua)
- Maintains advisory board / medical meeting documentation as necessary in project files (including but not limited to overall budget management, compliance approvals, and legal contracts); manages vendors working on meetings and advisory boards from vendor selection through final deliverable
- Supports the preparation of metrics and status reports, and present information to organizational leadership, program teams and other groups
7
Responsibilities For Senior Manager, Medical Affairs, Immuno Resume
- Maintains ongoing relationship with compliance, legal and finance to ensure the current processes for the US are followed and properly conducted; this includes working with Compliance to address any gaps in the process
- Assists with the monitoring, quality, and compliance of Medical programs and reporting of medical deliverables and presents those findings to key business stakeholders and internal Medical leadership
- Sensitize business to the nature of operating segment-Doctors / Patients
- Leadership– through visible and robust leadership ensure that Medical Affairs Operations is a valuable and critical partner in enabling the Business
- Customer Excellence - Embed a customer-focused culture by aligning processes with customer needs
- Conceive, plan and implement the academic/ scientific initiatives
- Flexibility to modify initiatives based on quality and feedback
- Indepth medical expertise and knowledge of multiple therapy segments
8
Responsibilities For Senior Business Manager, Medical Affairs Resume
- Knowledge of IFPMA / other ethical guidelines related to pharmaceutical industry
- Knowledge of SOPs for various internal job processes
- Develop ethical and scientific interface between company & customer both internal and external
- Actively promote patient care initiatives
- People Management - Manage and coach team members to ensure a high level of performance, and provide support and guidance on career and development plans
- Stakeholder Collaboration - Work with internal and external stakeholders to ensure optimal customer experience that meets needs and maintains high standards of compliance and is a valuable and enabling partner for the Janssen business
9
Responsibilities For Manager, Medical Affairs & Credentialing Resume
- Performance & Compliance – Ensure the capability of all medical operations functions is robust, accountable and performing at a high level to meet internal and external customer needs, as well as local, regional and global compliance requirements
- Quality Performance– work closely with the regional Business Quality team and the cross-sector QMS team to ensure that Janssen complies with all company and regulatory requirements and is audit ready
- Credo Role Model - Serve as a role model for making CREDO based decisions, creating a trusting, collaborative and ethical work environment while maintaining high levels of quality, compliance and accountability to ensure appropriate business growth
- External– Consumers, patients, health care professionals, academics, TGA, Medsafe
- Internal– personnel from various departments/functions (ie. Sales, Marketing, Medical Affairs, Health Care Compliance, Healthcare Solutions, Finance), Regional Business Quality, Cross-sector Quality
- Provision of competitively positioned promotional materials that comply with applicable FDA and corporate regulations, policies and guidance
- Analyze whether clinical and non-clinical promotional claims are supported
- Provide insight, judgment and sound decisions on promotional programs and tactics for assigned products
10
Responsibilities For Senior Manager, Medical Affairs SMA Resume
- Maintain a deep and current awareness of evolving FDA regulations and interpretations, FDA advisory comments, enforcement letters and policy issues affecting the pharmaceutical/biologics industry and communicate relevant information appropriately to stakeholders
- Provide input on promotional implications of proposed clinical study designs, and serve as a MA liaison with Sanofi Genzyme Rare Clinical Development
- Develop/maintain an in-depth understanding of labeling for assigned company and competitor products and the subsequent translation of that knowledge into the development of promotional materials
- Authors clinical evaluation plans (CEP), clinical evaluation reports (CERs), clinical trial protocols (pre- and post-market) and other scientific documents (as appropriate)
- Provide scientific support by interpreting safety and effectiveness results data, including data mining, compiling, analyzing and summarizing data from all applicable sources
- Collaborate with cross functional teams on the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review and accurate data reporting
- Summarize key clinical evidence from published literature and provide updates to internal stakeholders (as appropriate)
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