Training and Educational Opportunities for Medical Writers

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• Plan, organize and supervise Data Management activities for studies allocated to local staff. Ensure global clinical data management best practices and knowledge thereof in a standardized, transparent, and efficient manner. Assume responsibility as a partner for the planning, resourcing, and execution of relevant internal and external data management activities.
  
• Act as a study data manager in assigned studies, i.e. manage Study Data Management Teams and assume operational responsibility.
• Ensure adequate application of global clinical data management best practice for all assigned studies.
• Ensure the adequate support of clinicians in medical.
• Contribute to the preparation of data monitoring plans (coordinate amongst Study Teams, Global Medical Surveillance, Drug Safety Monitoring Boards, Authorities and Ethics Committees) for all assigned studies .
• Ensure the availability of protocol deviation documents for all assigned studies.
• Support maintenance of project and therapeutic area standards (CRFs, eCRFs, data structure, listings, edit checks, derivations, code lists, instructions for handling) and consistency in co-operation data management counterparts. Negotiate and communicate above standards with counterparts in neighboring functions such as the Statistics function.
• Ensure appropriate medical coding within studies and application of global and project standard coding rules and conventions for all assigned studies.
• Ensure adequate documentation of all activities within the sub-function for all assigned studies.

• Bachelor's Degree in a health science or Informatics, and 8+years experience, of which  2+ years were as a Study Data Manager; or equivalent. Alternatively, incumbent must have a Masters degree and 6+ years of experience.
• Experience in either case includes an understanding of medical terminology, disease states, encoding systems (i.e. MedDRA, WHO-DD, microorganism classification, etc.) and of regulations and guidelines (i.e. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPPA]).
• A solid understanding of database theory and experience in using data management methodologies and technologies (e.g., data computerization, storage and retrieval methods, electronic data capture) in the setup, conduct and closeout of clinical studies is required.
• Working knowledge of at least one industry-relevant relational database application/CDMS (e.g., ClinTrial, Oracle Clinical, etc.) and/or EDC application is required.
• Demonstrated use of at least one data review tool/programming language (e.g., SAS, PL/SQL, SQLPlus, iReview/jReview) for development and generation of data listings, ad hoc queries, data tabulations and status or system reports is desired.
• Incumbent must understand information flows in clinical development.
• Effective oral and written communication skills are essential.
• Incumbent must possess excellent interpersonal relationship skills and be able to interact with individuals across all levels of Global Clinical Organization, Medical, Statistics, and the global community in order to successfully complete assignments.
• Incumbent must possess proven self-management skills and the ability to coordinate local resources.

• Serve as Lead Statistician for a project and serve as an advisor to Clinical Project Team on statistical, scientific, and regulatory issues.
• Review clinical study protocols and medical research reports to ensure all support the project's global goals.
• Work closely with Statistical Programmers on all project related tasks to ensure consistency in analysis data sets, statistical summary tables, listings, and figures throughout the project.
• Work closely with the function Global Integrated Analysis on generation of integrated summaries and analysis for inclusion in Global Regulatory submissions.
• Create and maintain Project Biostatistical Plan.
• Oversee Study Statisticians in producing statistical methodology sections and statistical analysis plans according to global and regional standards, procedures and regulatory guidelines.
• Respond to inquiries from health authorities, investigators, and/or internal partners and communicate with health authorities on challenging statistical issues arising in study design and analysis.
• Ensure accurate and timely deliverables of statistical work outsourced to a CRO for the project.
• Serve as a Study Statistician for complex key clinical studies.

• MS or PhD in Statistics or Mathematics with a specialization in Statistics.
• MS with a minimum of 4 years or PhD with a minimum of 3 years experiences as a statistician in several (comparable) projects in pharmaceuticals, biotechnology, CRO, or another relevant field of experience.

• Develops publication strategy and supervises Medical writing for clinical and research topics related to existing and developmental products.
• Ensures that scientific manuscripts, abstracts, posters, symposium presentations and proceedings are optimized regarding timing and their content in line with brand strategy on an international scale.
• Provides clinical data about the brand's efficacy, safety and advanced product claims.
• Develops documents for registration of new indications, reviews marketing and public relations materials.
• Supports Post Registration Clinical Trial strategy in the global Med. & Scient. Aff. group.
• Provides guidance for development and review of scientific manuscripts, abstracts, posters and symposia proceedings, and decides about in house writing or producing these items by medical communication agencies.
• Chairs Global Scientific Publications Committee that  prioritizes objectives and communication strategies by interpreting scientific data relevant to hematology products and presenting these data in a timely fashion in appropriate publications, scientific meetings, international and local congresses, and continuing education programs.
• Supports and motivates R&D department, including Clinical Development to increase the number of manuscripts and accelerate their publication, as well as the number of presentations and posters at medical congresses to maximize the exposure of (client) research.
• Provides scientific background for "medical/marketing" messages jointly with cross-functional partners within Brand Team and Regions, and is involved in writing relevant parts of the Brand Plan.
• Contributes to post registration trial strategies, and is part of the PRT team.
• Supervises current study and publication data base, updates of product monograph, content of scientific messages on congress booth panels. 
• Ensures compliance with (client) SOPs on manuscript authorship and Legal/Medical/Regulatory sign-off process.
• Updates global hematology websites regarding scientific content.
• Develops and reviews documents for registration, provides clinical data about the brand's efficacy, safety and advanced product claims for scientific material, public relations, and marketing documents. Provides answers to countries concerning specific scientific questions about products and disease states.
• Proposes key speakers and contributes to content of KOL presentations at satellite symposia, together with Scientific Affairs.
• Provides monthly Literature Alerts to countries, regional, global and research colleagues. Reviews medical training programs for regions/countries.
• Ensures that project costs and schedules are properly estimated and controlled, develops medical and publication planning budgets in agreement with the Dir. Med. & Scient. Aff.  and tracks budgets.

• PhD, MD, or PharmD degree in a scientific/medical discipline, plus a minimum of 5 years experience in medical writing.
• Knowledge about the area of hemophilia would be beneficial.
• Excellent ability to interpret and present scientific and clinical trial data, and understand statistical analyses.
• Must possess strong writing ability and outstanding interpersonal skills.
• Must be able to work in a positive manner to motivate individuals, including key opinion leaders, over whom the incumbent has no power, in order to influence their current and future dealings with (client) Hematology.
• Must be able to direct, guide the Scientific Communications Manager, serve as a resource for the global and regional brand teams and deal effectively with people at all levels, both within (client) and in the academic health care sectors. 
• The incumbent must keep current on competitive environments in major markets, including NA, EU, Asia Pacific and Latin America.
• He/she must also be able to work simultaneously on several different projects with a variety of objectives, and being able to determine the right priorities to ensure that deadlines are met and projects are successfully completed.
• Must be a team player, and have sensitivity to diverse cultures.

• Responsible for providing support to the Clinicap Pharmacology (CP) Study Managers by maintaining critical Clinical Pharmacology Clinical Trial Study Files and Documents as per Regulatory SOPs and also managing the study related databases such as MDD.
• Uses project management skills to compile, track, review and ensure timely completion of high quality MRRs (CSRs) prepared in the department or external writers, clinical trial protocols , amendments to protocols and integrated study protocols according to SOPs.
• Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.)
• Checks that study file components (eg, Investigator CV's, protocol and amendments, sample case report form) needed for the writing of medical research reports (MRRs) are checked in electronic archive (eg, Documentum) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (eg, heading styles, language, accuracy).
• Manages the preparation of documents needed for obtaining clinical trial insurance and the processing of these documents to Regulatory group.
• Proofreads, reformats and edits document text, as required, to ensure that all documents for a writing project meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing.  Reviews all documents and appendices to ensure consistency between and within documents. 
• Manages the review and approval of documents in the document management system using standard procedures; publishes documents prior to review and approval using electronic publishing tools.
• Supports, with guidance, the preparation and management of key Regulatory documents such as CTDs and INDs.

• Responsible for providing support to the Clinicap Pharmacology (CP) Study Managers by maintaining critical Clinical Pharmacology Clinical Trial Study Files and Documents as per Regulatory SOPs and also managing the study related databases such as MDD.
• Uses project management skills to compile, track, review and ensure timely completion of high quality MRRs (CSRs) prepared in the department or external writers, clinical trial protocols , amendments to protocols and integrated study protocols according to SOPs.
• Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).
  
• Checks that study file components (e.g., Investigator CVs, protocols and amendments, sample case report forms) needed for the writing of medical research reports (MRRs) are checked in electronic archive (e.g., Documentum) on a timely basis (i.e., based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (e.g., heading styles, language, accuracy).
• Manages the preparation of documents needed for obtaining clinical trial insurance and the processing of these documents to Regulatory group.
• Proofreads, reformats and edits document text, as required, to ensure that all documents for a writing project meet all requirements for formatting (e.g., styles, fonts, etc.) prior to final QC, compilation and publishing.  Reviews all documents and appendices to ensure consistency between and within documents.       
• Manages the review and approval of documents in the document management system using standard procedures; publishes documents prior to review and approval using electronic publishing tools. 
• Supports, with guidance, the preparation and management of key Regulatory documents, such as CTDs and INDs.

• Steer and manage all key departmental operational processes, including departmental databases, IT support and archiving according to Regulatory guidelines.  This includes (but is not limited to): ensuring that information from Clinical Pharmacology is up to date on several databases (e.g. WH-serious adverse event, SAR, HR database etc); interacting with IT to ensure timely and adequate IT support for the department, arranging for license for special software, etc.; organizing archival of study documents according to SOPs.    
• Manage all cross-departmental and global operational interactions that are essential for achievement of Clinical Pharmacology departmental goals.  This includes: interacting with many departments e.g. global regulatory submissions, global biometry, etc.; being a department liaison with administrative departments (e.g., HR for HR direct, SAP for ordering/payment, accounting/purchasing, etc.)
• Steer the implementation, within the department, of global SOPs (including Clinical Pharmacology SOPs) and Regulatory guidelines related to processes and medical writing.  This includes interpreting and implementing, within the department, key global SOPs related to processes and medical writing, steering the implementation in the department of key regulatory guidelines, reviewing and commenting on new global clinical pharmacology SOP's. 
• Steer the Medical Writing group within the department.  This includes supervising and managing medical writing coordinators, planning and tracking internal resources and contract external resources in order to meet the timelines for key documents. 
• Steer and manage the preparation of clinical pharmacology sections of major Regulatory submission documents.  This includes supervising the technical preparation of clinical pharmacology sections of majr regulatory submission documents such as CTDs, NDAs, INDs and IMPDs; attending CTD, NDA, IND, IMPD tracking meetings as a representative from the department; working with other therapeutic areas on shared regulatory submissions.
• Develop standards and guarantee the timely execution of the preparation, review and approval of Medical Research Reports (MRRs) for all studies performed by specified CRO.
• Guarantee timely development of clinical study protocols and protocol amendments  and provide other necessary support for implementation of CP studies.
• Functionally, interact directly with the Global Head of Clinical Pharmacology Process & Resource Management (for process issues) and the Global Head of Clinical Pharmacology Operations (for medical writing issues) to ensure smooth and coordinated Global Clinical Pharmacology processes and medical writing.

• Coordinate and monitor internal budget spending for supplies, meetings and general contracts.  Assist cost center head with departmental budget forecasting, reconcile charges against purchases assuring that billing and payments are coded and charged accurately.  Routinely meet with members of RP&D Controlling to monitor expenses and update expenditures.  Minimize spending while providing the necessary materials for departmental operation. Process payments/grants via SAP and maintain appropriate documentation.  
• Interact directly with counterparts (Heads) in Process Management and Medical Writing in Wuppertal and Berlin.

The Scientific Writer is the medical writing expert responsible for the research, writing and editing of regulatory documents. The incumbent will provide full lifecycle support from clinical study protocols through regulatory dossier preparation and submission. Responsibilities will include assuring quality and timely preparation of clinical documents across all therapeutic areas, including clinical study reports, clinical study protocols, investigator's brochures, and clinical summaries and overviews.