Position with pharmaceutical company is 3-month contract to possible perm.

Responsibilities

1. Responsible for supporting CRAs and MDs in clinical protocol development, clinical study reports, Investigator's Brochures, informed consents and INDs/IMPDs. Responsible for researching, writing and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation.
2. Will also contribute to the development of medical writing infrastructure. Remains informed of the latest professional, technological, and regulatory developments in medical writing, as well as therapeutic areas. Manages medical writing project timelines and manages all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents and offers guidance in the preparation of regulatory and publication documents.
3. Organizes, conducts, and leads document production meetings and other meetings as necessary.
4. Responsible for developing and managing, Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, IND sections. Proposes applications
5. Responsible for supporting the development of departmental infrastructure such as contributing to research, acquiring a document management system, establishing style guides, and generation of templates and processes.

1. An ability to create effective presentations from raw data is essential.
2. An ability to interpret statistical and clinical data is essential. Must have an ability to work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required.
3. Strong written and verbal communication skills are required.
4. An understanding of clinical research, biostatistics, and regulatory affairs is required.
5. Must have experience writing clinical protocols, clinical study reports, and IND sections. Good computer skills are required. Working knowledge of MS word, Excel, Power point, Lotus notes is a plus.

1. A Bachelors/Masters degree in a scientific discipline with a strong journalism background is required.
2. Equivalent experience may be accepted.
3. A minimum of 8 years in a pharmaceutical, biotech, or CRO medical writing position is required.
4. A minimum of 6 years writing management experience is also required.
5. A minimum of 5 years previous supervisory experience is required.  

If interested, contact: 

Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing
T: 215-536-6979
F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com  

Position is 11-month contract.

Description

1. Uses project management skills to track, review and ensure timely completion of high quality documents.
2. 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.).
3. Independently compiles complete drafts of report appendices for clinical phase 1 /2a studies.
4. Act as a central resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines.  Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.
5. Work with key interface partners to facilitate the completion of clinical study reports and their appendices.  Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards.  Checks that study file components (eg, Investigator CV's, protocol and amendments, sample case report form) needed for the writing of CSRs are checked into the electronic archive (eg, eDMS) 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).
6. Proofreads, reformats and edits document text, as required, to ensure that all report appendices meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing.  Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents. 
7. Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.
8. Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary.

Minimum Requirements

1. Bachelor's degree or equivalent with at least 2-3 years of experience the pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles.
2. The incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing world wide (eg ICH, FDA, EMEA).
3. The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards. 
4. The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas.
5. The incumbent must be a skilled user of word processing applications.

Contact

If interested, contact: 

Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing
T: 215-536-6979
F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com  

Position is 6-month contract.

Description

1. Bachelor's degree in relevant scientific discipline with a minimum of 3-5 years in pharmaceutical industry experience.
2. Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.
3. Good understanding of the global pharmaceutical drug development process and regulatory requirements for safety risk related documents. Additional knowledge of regulatory guidelines preferred (eg. Good Pharmacovigilance Practice and Good Clinical Practice Guidelines).
4. Demonstrated ability to perform detail-oriented review of complex data from a broad range of therapeutic areas and scientific disciplines. Have excellent attention to detail.
5. Demonstrated strong, effective organizational, facilitation, and interpersonal skills in communicating with cross-functional teams. Communicates with clarity and consistency while impacting alignment of stakeholder activities regarding safety risk related document reporting requirements. Successful and creative negotiation of difficult compliance issues. Strong ability to resolve and communicate quality issues, and perform root cause analysis.
6. Working knowledge of a document management system and basic knowledge of the document publishing process. Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and new learnings.

Responsibilities

1. Coordinate and verify the compliance of complex regulatory strategic safety risk related documents and submissions, with guidelines, local regulations, procedures and/or company requirements. Proactively gather information to improve training methodologies. Identify process improvement opportunities and champion their implementation, as assigned.
2. Perform detail-oriented review of complex safety risk related documents while leveraging several pieces of source documents (eg. meeting minutes, signal log, commitment database, SharePoint, document management system). Responsible for in process reviewing and QC/proof-reading of documents prepared by staff (for e.g. cross checking sections, data points, tables, regulatory templates). Prioritize to ensure that timelines are met. Participate in the development of quality-related processes and tools. Provide support for management of quality issues. Facilitate and advise on corrections, corrective and preventive actions related to designated quality issues. Identify trending and consistency of all safety risk related documents in the department. From trended data by maintaining quality tracking, offer process improvement innovation ideas.
3. Provide advice for maintaining and performing qualitative and quantitative review and checking safety risk related documents. Maintain a familiarity with company systems and related processes. Provide quality consultancy to other personnel.
4. Ensure compliance with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with the medical writer to ensure timely completion and high quality of assigned documents. Share information in an open, balanced and objective manner with other quality management and other professionals to positive, results-orientated team environment.
5. Report findings of quality control reviews clearly and within required timeframes. Review documents and provide documentation of requirements to the lead author. Attend (or where required, lead) internal quality focused meetings. Provides training and guidance to all functional area staff members on a variety of quality topics.  

Contact

If interested, contact: 

Benjamin Tull, Sr. Recruiter inVentiv Health Clinical Strategic Resourcing
T: 215-536-6979
F: 973-673-9887 Email: Benjamin.Tull@inventivhealth.com Web: http://www.inVentivHealthclinical.com  

Position is permanent.

Description

1. Demonstrated ability to prepare a wide range of regulatory documents, such as clinical study reports and Investigator Brochures, as well as CTD summaries, pediatric investigational plans (PIPs), and regulatory responses, in-line with regulatory requirements and internal document standards
2. Contributes to other non-regulatory medical writing activities as required
3. Participates in submission teams and provides advice/guidance for optimal presentation of data for achievement of document objectives
4. Leads document timeline/resource planning for assigned projects within the submission team
5. Works collaboratively with functional contributors (clinical, biometrics, virology etc), ensuring all source information / data are appropriately reported in terms of accuracy, completeness and scientific interpretation, and in accordance with project timelines
6. Performance management may be required
7. Leads the compilation of final documents and appendices coordinating clinical, biometrics and regulatory contributions
8. Leads/contributes to development work in relation to document standards, continuing MS template development, and other aspects of document management. Proactively identifies areas for process improvement initiatives within Medical Writing
9. Provides scientific/regulatory writing services to support clinical trial reporting as well as a wide variety of regulatory submissions
10. Works with project teams across sites to produce complex clinical documents for global regulatory submissions
11. Is able to prepare a wide variety of regulatory documents independently or with minimal supervision
12. Writes multi-study summary documents for pivotal studies
13. Writes sections of product approval applications and other submissions
14. Works with Biometrics on clinical data interpretation
15. Reviews and prepares FDA briefing packages
16. Serves as a cross-functional resource.

Responsibilities

1. Requires a BS degree and 10+ years of relevant experience within clinical R&D or regulatory affairs such as pharmaceuticals/biotechnology
2. Candidates with advanced degrees and less than 10 years of experience may be considered
3. 5+ years experience in a medical writing/clinical submissions environment, directing/preparing documents for regulatory submissions
4. Can facilitate issue resolution and lead multi-functional teams with clear direction through complex processes
5. Demonstrated success in the independent preparation of regulatory documents, particularly at the individual study report level
6. Strong knowledge of regulatory document requirements/guidelines

Contact

If interested, contact: 

Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482.   

Position is permanent.

Description

1. Develop/write/edit documents for clinical development as well as technical/scientific publications
2. Will work closely with internal clinical development team members as well as external collaborators, such as KOLs and external vendors
3. Scope of documents range from pre IND through NDA
4. Provides broad medical writing and project management support for programs and efforts of the Clinical Development group
5. Able to develop documents from scratch
6. Documents include but are not limited to briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, Investigator's Brochure, clinical protocols and protocol amendments, model informed consents, interim and final clinical study reports, INDs, patient narratives, and other documents that support Clinical Development
7. Authors/co-authors/edits publications (manuscripts, review articles, abstracts, poster and presentations, etc.)
8. Performs literature searches/reviews as necessary to obtain background information and training for document development
9. Work with document templates and support eCTD document submissions
10. Facilitates review of materials/documents to enable timely finalization of documents
11. Builds agreement cross-functionally on timelines and document management to ensure efficient document finalization

12. Assists with development and implementation of SOPs

Requirements

1. Bachelor degree REQUIRED, PhD preferred
2. Pharmaceutical clinical/regulatory writing experience a MUST

Contact

Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482.  

Position is contract.

Our client is looking for a medical writer who has experience writing protocols, Investigator Brochures, and Clinical Study Reports. Infectious Disease experience is required. The candidate must be on site at least 50% of the time.

Contact

Please send your resume direct to Lindsey Summers at lsummers@pharmascent.com or call at 303-694-5482.