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Become A Medical Writer

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Working As A Medical Writer

  • Interacting With Computers
  • Getting Information
  • Identifying Objects, Actions, and Events
  • Updating and Using Relevant Knowledge
  • Communicating with Supervisors, Peers, or Subordinates
  • Mostly Sitting

  • Repetitive

  • Stressful

  • $70,000

    Average Salary

What Does A Medical Writer Do At Sanofi Group

* In this role, the Medical Writer:
* Works with project teams to prepare clinical and regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development.
* Contributes scientific knowledge, analytical skills, and insight to Clinical Scientific Operations, Project Team, and Submission Task Force meetings and to cross-functional working groups as needed to facilitate the preparation of reports, and the production of registration dossiers.
* Ensures a consistent style of presentation of clinical document to maintain quality and ease of review, and adherence to company standards.
* Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
* Required Education/Experience
* Experience as a Medical writer (preferably >3 years), or equivalent, or presenting relevant specialist qualifications (eg, PhD, PharmD).
* Good understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
* Detail-oriented with excellent inter-personal and communication skills.
* Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
* Ability to work both independently and collaboratively with a team in a cross-cultural, and geographically dispersed environment.
* Specific knowledge of company-targeted therapeutic areas is strongly desirable

What Does A Medical Writer Do At Pfizer

* Communicate Medical Writing's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
* Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations.
* Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.
* Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
* Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
* If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team.
* Produce documents in conjunction with external vendors.
* Review documents produced by vendors and help evaluate vendor performance.
* Understand relationships and dependencies between documents and analyses produced for regulators.
* Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.
* Develop and sustain constructive relationships within other Pfizer lines including country organizations.
* If assigned by manager, serve as the Medical Writing 'point of contact' for all document issues for a given product or set of products.
* Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line

What Does A Medical Writer Do At Abbvie

* Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
* Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
* Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
* Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
* Provide medical writing support for multiple assets within a therapeutic area(s)
* Perform literature searches for drafting AMCP dossiers
* Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members.
* Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data
* Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines
* Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
* Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures.
* Must continually train/be compliant with all current industry and company requirements
* Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance

What Does A Medical Writer Do At Leidos

* The Medical Writer II is responsible for providing medical writing support to the NIAIDHIV Clinical Research in West Africa project, as well as other CMRP initiatives.
* Gathers, interprets, and integrates information, maintains proper version control, prepares and summarizes meeting proceedings
* Attends virtual and in-person meetings that may be located at the NIH campus in Bethesda; Prepares and distributes meeting minutes
* Coordinates team meetings and assists in the development of meeting agendas
* Drafts and edits monthly/quarterly/yearly project report deliverables and other documents or reports
* Prepares monthly in progress review (IPR) performance information in Leidos Biomed Project Management Office (PMO) SharePoint site
* Writes, revises, and provides editorial assistance for clinical research documents, including but not limited to clinical protocols, Investigator Brochures, clinical study reports, subject consent forms, and publications to medical journals through collaboration with the Principal Investigator (PI)
* Integrates various sources of information into a uniform style and language for regulatory compliance
* Ensures submitted documents are clear, complete, and accurate as to required content elements, specific language, and applicable regulatory requirements for human subjects research
* Drafts and edits Standard Procedures (SPs), Standard Operating Procedures (SOPs), and presentations
* Collaborates with various groups to assess whether specific project-related documents comply with regulatory requirements and Standard Operating Procedures (SOPs)
* Composes medical papers from outlines provided by clinicians for presentations
* Collaborates with high-level managers and various offices across CMRP and company wide
* Provides expertise in MS Word and Adobe Acrobat to create stable and effective fields, hyperlinks, and references
* Serves as a subject matter expert in advanced MS Word and Adobe Acrobat functions to ensure proper format, form, and style for documents
* Creates, maintains, and provides expertise for template documents and related instructions for documents
* Works collaboratively with other CMRP Medical Writers
* May travel internationally up to 10

What Does A Medical Writer Do At Quintilesims

* Act as Lead Medical Writer, with limited guidance from supervisory staff, and maintains consistent high quality and efficiency.
* Has confidence to use experience and initiative to tackle new/unusual document types and customer requirements.
* Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed.
* Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
* Identifies project needs, negotiates and tracks project timelines, and implements client requests with limited senior guidance.
* Offers proactive solutions and advice to customers as appropriate to experience.
* Reviews and monitors budget for assigned projects, including identification of out of scope activities, and ensures that revenue is recognized as appropriate.
* Provides senior review, mentoring, and guidance for documents prepared by junior staff.
* May act as Project Manager for stand-alone Medical Writing projects or as primary medical writing customer contact for one of our partnerships.
* May coordinate Medical Writing activities for a series of full-service projects, with focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking

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How To Become A Medical Writer

A college degree is usually required for a position as a technical writer. In addition, experience with a technical subject, such as computer science, Web design, or engineering, is important.

Education

Employers generally prefer candidates with a bachelor’s degree in journalism, English, or communications. Many technical writing jobs require both a degree and knowledge in a specialized field, such as engineering, computer science, or medicine. Web design experience also is helpful because of the growing use of online technical documentation.

Work Experience in a Related Occupation

Some technical writers begin their careers as specialists or research assistants in a technical field. They eventually develop technical communication skills and assume primary responsibilities for technical writing. In small firms, beginning technical writers may work on projects right away; in larger companies with more standard procedures, beginners may observe experienced technical writers and interact with specialists before being assigned projects.

Training

Many technical writers need short-term on-the-job training to adapt to a different style of writing.

Licenses, Certifications, and Registrations

Some associations, including the Society for Technical Communication, offer certification for technical writers. In addition, the American Medical Writers Association offers extensive continuing education programs and certificates in medical writing. These certificates are available to professionals in the medical and allied scientific communication fields.

Although not mandatory, certification can demonstrate competence and professionalism, making candidates more attractive to employers. It can also increase a technical writer’s opportunities for advancement.

Advancement

Prospects for advancement generally include working on more complex projects and leading or training junior staff. Some technical writers become self-employed and produce work on a freelance basis.

Important Qualities

Communication skills. Technical writers must be able to take complex, technical information and translate it for colleagues and consumers who have nontechnical backgrounds.

Detail oriented. Technical writers create detailed instructions for others to follow. As a result, they must be detailed and precise at every step so that the instructions can be useful.

Imagination. Technical writers must be able to think about a procedure or product in the way a person without technical experience would think about it.

Teamwork. Technical writers must be able to work well with others. They are almost always part of a team: with other writers; with designers, editors, and illustrators; and with the technical people whose information they are explaining.

Technical skills. Technical writers must be able to understand highly complex information. Many technical writers need a background in engineering or computer science in order to do this.

Writing skills. Technical communicators must have excellent writing skills to be able to explain technical information clearly.

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Medical Writer jobs

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Real Medical Writer Salaries

Job Title Company Location Start Date Salary
Associate Director, Medical Writer Ariad Pharmaceuticals, Inc. Cambridge, MA Aug 26, 2011 $173,367
Medical Writer Integrated Resources, Inc. Cambridge, MA Sep 15, 2016 $131,481
Medical Writer Integrated Resources, Inc. Cambridge, MA Feb 03, 2016 $131,481
Medical Writer Havas Health, Inc. New York, NY May 01, 2016 $120,000
Medical Writer Planet Pharma, LLC Woodcliff Lake, NJ Sep 26, 2016 $118,959
Medical Writer Planet Pharma, LLC Woodcliff Lake, NJ Sep 19, 2016 $118,959
Medical Writer Millennium Pharmaceuticals, Inc. Cambridge, MA Oct 03, 2011 $115,000
Medical Writer II-Clinical Green Key Temp LLC Parkersburg, IL Jan 09, 2016 $107,765
Medical Writer Ockham Development Group, Inc. Skillman, NJ Jan 11, 2010 $106,437
Medical Writer Bristol-Myers Squibb Company Hopewell, NJ Jan 01, 2013 $102,000
Medical Writer Havas Health, Inc. New York, NY Dec 30, 2013 $95,000
Medical Writer Health Interactions, Inc. San Francisco, CA Sep 15, 2016 $92,500
Medical Writer Novavax, Inc. Gaithersburg, MD Sep 18, 2015 $88,000
Medical Writer Envision Pharma, Inc. Philadelphia, PA Nov 25, 2009 $78,790
Medical Writer Envision Pharma, Inc. Southport, CT Mar 19, 2014 $78,750
Medical Writer Ogilvy Commonhealth Worldwide LLC Parsippany-Troy Hills, NJ Sep 27, 2011 $75,000
Medical Writer Ogilvy Commonhealth Worldwide LLC Parsippany-Troy Hills, NJ Sep 24, 2011 $75,000
Medical Writer UBC-Envision Group Southport, CT Mar 12, 2012 $75,000
Medical Writer Ogilvy Commonhealth Worldwide LLC Parsippany-Troy Hills, NJ Sep 10, 2011 $75,000
Medical Writer UBC-Envision Group Southport, CT Mar 19, 2012 $75,000
Medical Writer PPD Development, LP Morrisville, NC Sep 19, 2010 $69,930
Medical Writer The Emmes Corporation Rockville, MD Apr 01, 2013 $69,622
Medical Writer The Emmes Corporation Rockville, MD Jan 04, 2013 $68,289
Medical Writer Comprehensive Healthcare Systems, Inc. Edison, NJ Jan 09, 2016 $67,780
Oncology Scientist/Medical Writer National Comprehensive Cancer Network, Inc. Fort Washington, PA Sep 20, 2011 $66,456 -
$76,686
Medical Writer, Feasibility Services PPD Development, LLC Morrisville, NC Sep 18, 2013 $66,123 -
$68,296
Consultant, Technical Writing/Medical Writer Cardinal Health, Inc. Dallas, TX Sep 01, 2013 $65,624 -
$108,750

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Top Skills for A Medical Writer

SafetyNarrativesOncologyFDACsrsNDAClinicalTrialsExecutiveSummariesClinicalResearchTherapeuticAreasINDInvestigatorBrochuresQCEfficacyPowerpointPhaseIIIMedicalEducationSlideDecksProjectManagementPatientNarrativesICH

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Top Medical Writer Skills

  1. Safety Narratives
  2. Oncology
  3. FDA
You can check out examples of real life uses of top skills on resumes here:
  • Support the overall the Safety Narratives Process within Hematology/Oncology by authoring and reviewing narratives for assigned studies.
  • Led the writing and managed investigator and reviewer input for a grant for a complex oncology clinical trial.
  • Develop documents following guidelines for internal PRC submission and following FDA regulations.
  • Drafted and wrote clinical study reports (CSRs) for drugs and medical.
  • Attended advisory board meetings and wrote of the executive summaries for National and International agendas about rolapitant (Schering-Plough).

Top Medical Writer Employers

Medical Writer Videos

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