Manager Medical Resume Sample

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Pearlie Effertz
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Work Experience

Manager, Medical Writing
05/2015 - PRESENT
Chicago, IL
  • Participates in the development of protocols, investigator’s brochures, and other study documents, as needed
  • Is able to prepare a wide variety of regulatory documents independently or with minimal supervision
  • Works with Biometrics on clinical data interpretation
  • Serves as a cross-functional resource and medical writing lead representative on cross-functional product teams
  • Provides strategic and operational input on the development of clinical regulatory submission documentation
  • Can facilitate issue resolution and lead multi-functional teams with clear direction through complex processes
  •  Provide technical and medical information to external customers (HCPs, third party vendors and internal staff (sales and marketing)
Senior Manager, Medical Information
11/2010 - 04/2015
Detroit, MI
  • In addition to managing the regional functions associated with the MediCal Improvement Unit, also assist the regional director with the roll out of pediatric care coordination in the NCAL region
  • Provide management and leadership to the Medical Writing organization in such areas as personnel, objectives, projects, best practices, and responsibilities
  • Monitors proposed and current global regulations and guidance and advises on impact of such regulations and guidance on the company
  • Manage evidence database capturing key evidence reports, publications, and external communications. Support dissemination of key evidence summaries to stakeholders
  • Provide work direction, training, and regulatory advice to direct reports, other members of the project teams and other corporate functional leaders
  • Collaborate with Regulatory Affairs and provide support/strategy to respond to questions from regulatory agencies
  • Manages project schedules, and for all documents, coordinates and manages the review process, leads discussions on document revision, revises documents per comments from external and internal reviewers, and ensures timely approvals from all reviewers
  • Candidates with pertinent industry-related experience and/or post-graduate specialty/residency are desirable
Senior Manager, Medical Writing
03/2007 - 07/2010
Los Angeles, CA
  • Possesses solid skills at critically evaluating literature and writing/summarizing clinical and scientific data
  • Demonstrates effective relationship management and customer orientation
  • Exhibits strong oral and written communication skills
  • Able to work in a fast-paced environment with competing priorities
  • Effectively deals with ambiguity and adapts quickly to change
  • Good collaboration and interpersonal skills with local, regional and global colleagues
  • Works independently on moderately complex projects


University of Delaware - Wilmington Campus
2001 - 2006
Bachelor's Degree in Business Administration

Professional Skills

  • Strong oral communication, presentation, project management and prioritization skills and excellent interpersonal relationships is also required
  • Demonstrated ability to apply excellent judgement and decision-making skills
  • Strong computer skills; intermediate level experience with MS Office products including Outlook, Excel, Word and PowerPoint
  • Excellent interpersonal skills and a demonstrated ability to manage conflict
  • Prior CSR and Summary Document generation experience. Prior experience with submissions in Common Technical Document (CTD) format
  • Demonstrated project management, problem solving, organizational, and negotiating skills
  • Strategic thinker with excellent problem solving and decision making skills

How to write Manager Medical Resume

Manager Medical role is responsible for interpersonal, computer, software, medical, leadership, mainframe, word, literature, communications, presentation.
To write great resume for manager medical job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Manager Medical Resume

The section contact information is important in your manager 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
  • Email
  • Telephone number

Work Experience in Your Manager Medical Resume

The section work experience is an essential part of your manager 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 manager 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 manager medical position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions. Representative Manager Medical resume experience can include:

  • Excellent project management skills to organize work and handle multiple projects at the same time. Ability to guide teams during document development
  • Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships
  • Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills
  • Excellent interpersonal, written, and verbal communications skills are essential
  • Solid understanding of the drug development process. Solid knowledge of relevant regulatory guidelines as well as medical and statistical concepts
  • Effectively facilitates communication with a variety of individuals, including team/functional leadership and members of senior management

Education on a Manager Medical Resume

Make sure to make education a priority on your manager medical 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 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 Resume

When listing skills on your manager 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 manager medical skills:

  • Leverages strong analytical, critical thinking and problem-solving skills; Skill in analyzing information, identifying trends and presenting solutions
  • Strong critical thinking skills to identify medical issues, suggest alternatives, and negotiate effective solutions
  • Excellent time management, scheduling, interpersonal and organizational skills
  • Excellent medical writing and oral communication skills
  • Strong project and operations management skills; inventory management, resource planning, developing and leveraging reports; developing policies and procedures
  • Excellent written and verbal communication skills. Mastery of the English language, with a comprehensive understanding of English grammar and punctuation

List of Typical Experience For a Manager Medical Resume


Experience For Manager, Medical Writing Resume

  • Able to effectively work and collaborate in a virtual work environment
  • Experience in the industry
  • In depth knowledge of departmental processes and ability to contribute to improving and developing processes
  • Explore customer’s needs using existing channel
  • Work with the outsourcing partner to ensure day to day deskside services are delivered to meet SLA’s and end user satisfaction

Experience For Senior Manager, Medical Information Resume

  • Responsible for providing input into the Global Therapeutic Area’s strategic direction and goals
  • Proficiency with computer and software applications (i.e., Microsoft office), experience with MI systems used for information requests and content management, and skilled at utilizing medical literature and drug information databases
  • Lead Medical Information initiatives and participate in cross-functional teams (such as Medical Scientific Review Committee (MSRC), Promotional Review (PMRC), etc). In addition, manage and mentor direct reports and provide oversight of their performance in MSRC, PMRC, etc.)
  • Leads key training and development activities for self and direct reports to ensure high-level scientific and medical knowledge, understanding of legal, compliance, and regulatory requirements, Codes of Practice, and corporate policies/procedures; provides mentorship to direct reports to support their professional and personal development
  • Provide scientifically balanced medical and drug information (in accordance with established department guidelines, resources, regulatory guidance’s) to unsolicited inquiries on Sunovion products received from multiple
  • Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects

Experience For Manager, Medical Information Resume

  • Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained
  • Writes and coordinates other documents for submission to regulatory agencies, including IND, NDA, and CTD items
  • Uses clinical knowledge to assist in the written interpretation of clinical data and to guide others in their presentation of clinical data
  • Oversee assignments, monitor staff workload, and provide guidance for completion of assignments
  • Create and modify project timelines, allocate resources, and forecast departmental workload
  • Excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data
  • Effective communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits
  • Develop, review, and modify proposals and budgets for presentation to clients
  • Participates in weekly Therapeutic Literature Alert meetings and completes associated deliverables

Experience For Senior Manager, Medical Writing Resume

  • Responsible to live and drive Stryker’s Values: Integrity, Accountability, People and Performance
  • Within Therapeutic area develops strategies and resources to address customer and department needs. Participates in strategic initiative planning and implementation and assists assigned manager with execution of therapeutic team strategies
  • Facilitate intake and triage of adverse events and product complaints as they relate to Seattle Genetics’ products
  • Assist Baxter’s regulatory and Quality groups by providing clinical input and support into the evaluation of product complaints and adverse events when requested
  • Research new solutions and engage external vendors to provide demos of tools / technologies that could enhance NAMA’s abilities to deliver on its key strategies
  • Create Digital Medical strategies to drive our critical medical customer’s strategies and objectives in support of external engagement with HCPs, providers, payers, and policy makers

Experience For Manager, Medical Systems Resume

  • Reviews statistical analysis plans and table/figure/listing specifications for grammar, format, and
  • Primary interface with national/regional OD KOL’s
  • Responsible for 1 or more of the following: therapeutic area project work, major or complex product, multiple diverse indications for one product, or small functional team
  • Within Therapeutic area, develops strategies and resources to address customer and department needs. Participates in strategic initiative planning and implementation and assists assigned manager with execution of therapeutic team strategies
  • Receives, documents, and responds to written medical information requests. Provides information upon request for medical and clinical inquiries from consumers, clinical sites and healthcare professionals regarding Otsuka products, including, but not limited to, product information and support
  • Updates and/or creates medical letters pertaining to Otsuka products
  • Provides process training to sales representatives as needed

Experience For Senior Manager, Medical Review Resume

  • Provide assistance and/or training to other medical information personnel (i.e. consultants)
  • Serves as an educational resource to both internal and external customers
  • Recognizes and gathers, according to FDA guidelines and company policies, initial information regarding any product complaint or adverse event of which made aware during the handling of medical information and medical device inquiries
  • Acts as a subject matter expert for one or more therapeutic areas (TAs) and all products related to that business unit
  • 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 by obtaining key benchmarking metrics, ensuring resource availability and training, and developing a library of standard response documents pre-approved in time for product launch
  • Maintains up-to-date repository of organized/tagged materials for assigned TA(s) to ensure easy retrieval upon request

Experience For Manager Medical Center Resume

  • Provides back-up support for US Medical Information staff as needed
  • Education Level and Languages Required
  • Directly and independently handle unsolicited medical inquiries escalated to the level of Senior Manager
  • Support review and approval of promotional and non-promotional materials
  • Manages strategic clinical regulatory document planning efforts to fulfill objectives. Accountable for meeting the main objectives of clinical writing projects in therapeutic area(s) within established timelines, budgets, and with an appropriate quality level
  • Provides oversight and project management for writing projects for multiple compounds and/or indications within assigned therapeutic area, ensuring accuracy and adherence to timelines and processes
  • Provides managerial oversight of staff member(s) that support multiple compounds and/or indications of a major or complex product within assigned therapeutic area, including oversight of work products and activities

Experience For Associate Manager Medical Information Resume

  • Works with development team and functional area to execute project objectives and strategies. Establishes, maintains, and expands business relationships with all functional areas collaborating on projects
  • Communicates effectively across functional areas and within department to accomplish project objectives. Presents project and professional information to appropriate individuals in a concise, clear, and objective manner, and with grammatical accuracy. Represents functional area on routine issues and facilitates multidisciplinary communications
  • Proficiently learns and applies therapeutic area and product knowledge to scientific projects. Develops expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of clinical documents and ensures staff understands, complies, and applies them to work products
  • Actively supports clinical project team(s), alone or in collaboration with other MWs, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary
  • Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams
  • Develops effective collaborations with other functional lines in Alexion
  • Researches and analyzes scientific information to answer escalated MI inquiries taking into consideration labeling differences between countries

Experience For Manager, Medical Bill Review Resume

  • Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory, and pharmacovigilance colleagues
  • Ensures consistent support and implementation of MW standards
  • Provide verbal and written clinical and technical responses to internal customers
  • Serves as the subject matter expert for MI on responsible product(s) and associated therapeutic area(s)
  • Creates, maintains and optimizes local, regional and global MI document collections by ensuring that responses are medically and scientifically accurate, timely, fair balanced, and meet customers’ needs

Experience For Manager Medical & Scientific Affairs Resume

  • Ensures the availability, accuracy, and maintenance of medical content via digital channels such as the MI country websites, Apps (PfizerMeds App), and Medication Pages, as well as performing website search optimization for ease of content identification by customers
  • Collaborates with Global colleagues to ensure an open exchange of product information, business intelligence and best practices Analyzes inquiry data to identify trends and communicates relevant information to the Product/Therapeutic Area cross-functional team(s)
  • Actively participates and interacts with medical colleagues and cross-functional team members to ensure sharing of insights and data and assists in the management of product issues/crisis
  • Commitment and ability to producing high quality documents that comply with internal and external standards
  • Collaborates with internal stakeholders where applicable to ensure MI work is aligned within the scope of Pfizer Medical and Pfizer business as a whole

List of Typical Skills For a Manager Medical Resume


Skills For Manager, Medical Writing Resume

  • Possesses strong team work attributes. Strong ability to provide informal leadership, including mentoring, peer coaching and providing feedback
  • Experience in medical writing, medical information/drug information, and/or relevant clinical experience
  • Strong knowledge and / or experience with Baxter or competitive products is helpful
  • Medical writing experience or other relevant pharmaceutical industry experience
  • Demonstrated success building and lead high performing teams
  • Strong ability to provide informal leadership, including peer coaching and feedback
  • A proven project management background is essential with a history of leading large to mid-size projects correlating technology with business requirements.
  • Adaptable and thrives in a fast-paced dynamic environment with changing priorities
  • Demonstrated accountability for delivering on-time, high quality work

Skills For Senior Manager, Medical Information Resume

  • Experience in Medical Industry in Marketing or Sales role an asset
  • Regulatory medical writing experience required
  • Experience in management of complex medical writing projects
  • Experience managing budgets and grants/contracts required
  • Experience in medical setting operations is required
  • Clinically skilled, licensed health care professional in Nursing, Pharmacy, or other allied health profession
  • Relevant experience in medical writing, preferably within the pharmaceutical industry
  • Understand and interpret statistical results of clinical studies and understanding good data management practices is required

Skills For Manager, Medical Information Resume

  • Upervisory/management experience
  • Knowledge of clinical evaluation report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is required
  • Able to quickly develop therapeutic expertise across medical device portfolios, business objectives, clinical data/evidence is required
  • Clinically skilled, licensed healthcare professional, Pharmacist, Register Nurse, or other allied health professional
  • Experience in a leadership/management capacity required
  • Motivated to function proactively, operate with a sense of urgency and bring tasks to completion
  • Exhibits comprehensive knowledge of MI work and processes as well as good understanding of other internal stakeholders
  • Participate in the interviewing and hiring of new employees within Medical Writing

Skills For Senior Manager, Medical Writing Resume

  • Help monitor and manage Medical Writing Group resourcing
  • Represent Medical Writing on project teams ensuring proper document preparation and documents are finalized within timelines
  • Safety monitoring committee/data safety monitoring committee charters
  • Regulatory meeting briefing packages
  • Mentor Medical Information team members; ensure training to enhance and maintain clinical competencies and help to support development of the team

Skills For Manager, Medical Systems Resume

  • Identify market trends, customer needs, and changing clinical practice and communicate back to therapeutic areas and cross functional stakeholders
  • Manage Medical Writing staff
  • Ensures that the frontline personnel have the necessary training and resources to appropriately meet customer needs and expectations
  • Position reports directly to Scientific Communications Director
  • Read, interpret, and convey complex scientific information
  • Work collaboratively towards a common goal

Skills For Senior Manager, Medical Review Resume

  • Broad and comprehensive knowledge and understanding of medical documentation requirements and an understanding CMS, Medicaid and/or Commercial insurance programs, particularly the coverage and payment/reimbursement rules
  • Thorough working knowledge of CPT/HCPCs/ICD-9/ICD-10/MS-DRG coding and demonstrated capability in developing and implementing effective coding audit strategies
  • Excellent verbal and written communication and interpersonal skills; ability to effectively communicate at all levels within the organization both internal and external
  • Co-ordinate priorities in conjunction with Medical Information team member’s activities as they relate to US Medical Information objectives
  • Excellent verbal and written communications focused on scientific or technical communications
  • Strong leadership, project management, and ability to work with cross functional groups and geographies
  • Manage Medical Information (MI) inquiries. Research, respond, and document inquiries received, in accordance with FDA guidelines for the dissemination of MI
  • Create, maintain, and approve standard response documents, and other correspondences that are necessary to respond to the requests of internal and external customers, within the Medical Information Content Management system

Skills For Manager Medical Center Resume

  • Participate and lead initiatives that improve and streamline current processes within Medical Information to improve medical communication services to internal and external customers
  • Maintain current familiarity of published medical literature relating to product lines so that information can be provided to the business unit relating to clinical trends and their potential impact on product lines
  • Participate in initiatives that improve and streamline current processes within Medical Information to improve medical communication services to internal and external customers
  • Manage effectively one’s projects, and to meet deadlines while maintaining high quality standards
  • Direct experience with KOL engagement activities (either field or office-based)
  • Develop and consider innovative alternatives when addressing problems and opportunities
  • Thrive in a fast-paced team environment, and also work independently on projects. History of timely tactical execution
  • Familiar with technologies like SharePoint and CRM systems desired
  • BS/MS within scientific discipline required

Skills For Associate Manager Medical Information Resume

  • Work in a matrix environment on cross-functional teams
  • Identify, develop, and implement division/department projects which are focused on quality, utilization, process and/or outcome improvements
  • Develops and executes audit plans in accordance with client statement of work, compliance and company requirements
  • Provide audit guidance to medical review coders; identify trends, develop and implement solutions that optimize performance of the department
  • Applies in-depth expertise in both inpatient and outpatient medical coding to the development of policies, procedures, guidelines, coding issues/refining coding parameters, workflow and tools

Skills For Manager, Medical Bill Review Resume

  • Monitor and manage individual, team and overall inventory to ensure timelines are met. Use reports and experience to proactively identify potential backlogs and align resources to meet business needs
  • Hires, trains and develops staff; Proactively manages team production and quality performance, and: resolves conflict in a tactful and effective manner
  • Monitors and analyzes audit productivity and quality; identifies trends, determines root causes of inconsistencies or issues, and; develops and implements tools, training and solutions for resolving issues and continuous improvement
  • Effectively collaborates and builds credibility internally and externally; Leverages strong professional communication skills to effectively engage with and influence a wide range of internal and external audiences
  • Leverages strong industry and business knowledge to support strategy by conducting needs assessments, capacity planning, cost/benefit analysis, preparing staffing models, and establishing productivity and quality standards

Skills For Manager Medical & Scientific Affairs Resume

  • Maintains professional and technical knowledge by keep up to date of changes and emerging trends that affect our industry as it pertains to regulations, legislation and business trends
  • Experience working with business partners and internal clients and building effective, collaborative relationships
  • Prior experience with clinical regulatory writing document types
  • Two years of prior people management experience
  • At least five years’ experience in a medical staff services office, preferably within an academic medical center
  • Experience in HEOR and "Real World Data" desired
  • Experience developing and delivering presentations to senior management
  • Regulatory writing and submission experience
  • 5 – 10 years of experience in business intelligence and reporting in an industry environment

List of Typical Responsibilities For a Manager Medical Resume


Responsibilities For Manager, Medical Writing Resume

  • Experience developing coding issues and refining coding parameters for audit
  • Experience in allocating and managing resources
  • Significant auditing experience in a provider setting, or as a payor for a health insurance company
  • Medical writing experience in protocols and CSRs
  • Apply relevant knowledge and experience to solve complex problems, using flexibility and persistence as appropriate
  • Medical writing experience

Responsibilities For Senior Manager, Medical Information Resume

  • Experience managing external providers
  • Experience in collaborating with complex scientific concepts and people
  • Participate in process improvement work streams with Global Labeling Management and tracking and driving progress for each CCDS to ensure timelines are met
  • Assist with the Call Center Vendor training and Sales Representative training as needed
  • Author clinical submission documents and manuscripts including
  • Summary documents (including integrated summary of safety [ISS], integrated summary of efficacy [ISE], clinical overview, clinical summary CTD sections)
  • Provide process, content, and submission/document planning expertise. Advise team on resource utilization, efficiencies, timelines and interdependencies
  • Prepare and represent Medical Writing for internal (QA) and external audits (MHRA, FDA)
  • Summarise clinical trial data and analyse and interpret clinical data, discussing results with internal teams and KOLs

Responsibilities For Manager, Medical Information Resume

  • Mentor, coach, and/or otherwise assist in the training and development of other Medical Writers
  • Assist in managing Call Center vendor activities
  • Responsible for managing the medical information contact center
  • Leads the medical information processes for responding to unsolicited medical inquiries
  • Oversees the staffing of the Medical Information booth at medical congresses

Responsibilities For Senior Manager, Medical Writing Resume

  • 2) Is the incumbent in charge of leading other sanofi-aventis employees? No
  • Develop and perform training for outsourced providers
  • No positions reporting
  • Proactively seeks and takes appropriate risks to advance new solutions to improve MI processes and responses and to resolve problems
  • Facilitates the development and maintenance of formulary-related documents in support of improving access to state Medicaid and managed care formularies in the US
  • Maintain a thorough knowledge of Horizon’s products pertaining to pharmacology and toxicology as well as thorough knowledge of the clinical environment and medical procedures in which Horizon’s products are used

Responsibilities For Manager, Medical Systems Resume

  • Act as information liaison with other Horizon departments and maintain current and accurate reference materials for Medical Affairs staff. These references include but are not limited to
  • Plan, write, edit, format, and finalize clinical/regulatory documents, including, but are not limited to, clinical study protocols, clinical study reports, investigator brochures, annual safety updates, clinical summary documents, and other regulatory submissions
  • Effectively lead data interpretation and comment resolution meetings, and manage timelines for medical writing projects
  • Collaborate with Clinical Development, Clinical Operations, Clinical Pharmacology, Biostatistics, and other departments to draft and finalize documents
  • Interpret and present scientific and clinical trial data, as well as understand statistical analyses. Ability to strategically present data/results
  • Lead subject matter expert in depression in all matters related to medical information
  • Contribute to departmental/organization efforts to support new product launch preparation and activities
  • Provide accurate, balanced and timely medical and scientific information to internal and external customers such as health care professionals, consumers and other customers
  • Guide/mentor/supervise the medical information call center pharmacists and nurses for escalated cases

Responsibilities For Senior Manager, Medical Review Resume

  • Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Alkermes colleagues
  • Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints and are triaged accordingly to PV and QA
  • Proactively monitor the literature for new scientific information; identify relevant publications, analyze and communicate information of interest internally in an accurate, balanced and timely manner
  • Create and/or review for accuracy, communications containing medical and scientific content intended for internal and external customers (e.g., communications Q&A material, dear health care provider letters, documents for public comment, ect…)
  • Develop and/or identify content for the development of disease and product training material for sales associates and others as needed; provide live training upon request
  • Collaborate closely with members of other internal groups (e.g., Regulatory, Marketing, Sales, Legal, Clinical R&D) as needed

Responsibilities For Manager Medical Center Resume

  • Work with internal and external legal counsel to ensure compliance with company policies and procedures
  • Provide medical and scientific input and contribute to assigned product and project teams
  • Contribute to the review of internal promotional and medical materials as needed
  • Provide information and support for business activities such as relevant insights, knowledge of product data, etc
  • Attend scientific conferences to provide medical support and to staff medical information booth as assigned

Responsibilities For Associate Manager Medical Information Resume

  • Lead pre-conference Medical Affairs/Medical Information activities
  • Develop post-conference reviews and reports for internal stakeholders
  • Develop and maintain document timelines in line with business objectives. Manage writing activities to complete documents within agreed-upon timelines. Identify, communicate, and resolve issues impacting document timelines
  • Drive document preparation process within teams. Engage teams in document planning activities, including review of document shells, safety narrative plans, and mock/draft tables, figures, and listings. Plan and lead document review meetings to achieve consensus on document strategy, content, and format
  • Coordinate documents prepared by other writers as needed

Responsibilities For Manager, Medical Bill Review Resume

  • Support implementation of reviewer guidelines, process initiatives, and technologic innovations to improve document development process. Suggest changes to document processes or templates to improve quality and/or efficiency. Participate in process initiatives
  • BS/BA +7 years, MS/MA +5 years, PhD +3 years of medical writing experience in the pharmaceutical or biotech industry required
  • Work independently. Ability to work well under pressure and adapt to change as needed
  • Clinical study reports (CSRs)
  • Summary of Product Characteristics and US package circulars
  • Clinical sections of integrated product reviews
  • Manuscripts and abstracts for publication
  • Clinical sections of grant and contract proposals to NGO and government partners
  • IND and EU Annual Safety Updates

Responsibilities For Manager Medical & Scientific Affairs Resume

  • Responses to agency questions
  • Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging and style
  • Manages and prioritizes multiple projects and provides input to intricate problems and delivers solutions in a timely manner
  • Strong knowledge of searching the medical literature and drug information databases
  • Strong ability to evaluate and communicate scientific data to a variety of audiences in various settings
  • Reviewing protocols, statistical analysis plans and tables figures and listings

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