RUFUS ROBERTSON

** *. ******* ~ Hillside, IL ****2

Phone: 904-***-**** ~ Email: abiryo@r.postjobfree.com

CLINICAL RESEARCH & DEVELOPMENT

VISION STRATEGY PLANNING IMPLEMENTATION LEADERSHIP

As a medical writer I have a proven track record of drafting and revising

clinical development documents, including but not limited to clinical study

reports (Phase 1-4), clinical protocols, investigator brochures, patient

narratives in accordance with all applicable guidelines (eg, ICH/GCP) and

client SOPs. I have successfully interacted with investigators and

personnel in multiple departments to keep projects moving forward, ie,

preclinical research, clinical pharmacology, clinical and medical affairs,

biostatistics, regulatory affairs and data management.

Therapeutic Areas

. Oncology

. Pain Management

. Medical Devices

. Infectious Diseases

. Hematology

. Ophthalmology

. Diabetes

Skills:

. Excellent written English, able to accurately interpret data and

express findings in a clear and concise written manner.

. Excellent project/time management and organizational skills and

ability to work on own initiative.

. Flexibility in meeting challenging deadlines and changing

requirements.

. Comprehensive Microsoft Office, especially WORD but also PowerPoint

and Excel, skills and internet skills.

. Knowledge and experience in internet research.

. Ability to communicate with professionals from a variety of

backgrounds.

. Attention to detail-style, consistency, grammar, syntax, scientific

accuracy.

. Good interpersonal skills with confidence in managing

clients/authors

PROFESSIONAL EXPERIENCE

Research Pharmaceutical Services Jacksonville, FL

4/2012 - 12/2014

SR. MEDICAL WRITER

Led the evaluation, summarizing and writing of clinical study report data,

protocols, investigator brochures, summary documents, and other scientific

documentation for the optometry sector of research and development, while

consulting on research plans and ensuring their successful implementation.

. Drove all aspects of the document preparation process; received and

reviewed primary statistical output, drafted and distributed completed

documents for review, and compiled comments and edits as necessary for

Vistakon's contact lenses division for Phase I-IV (Medical Device)

studies

. Responsible for coordinating and capturing records for CAPA Review

Board and other such reviews pertaining to the CAPA system.

. Responsible for preparing & presenting data/reports regarding CAPA

metrics for submission to Site, Divisional and Corporate Management

Review.

. Understanding of clinical research, study design, biostatistics, the

regulatory environment, and medical terminology

. Provide accurate documents through an intensive internal review and

quality control process.

. Preparing and overseeing (6 Medical Writers based out of India) the

preparation of clinical regulatory submission documents and

manuscripts.

. As sole individual in-house medical writer, in charge of all

documentation editing and quality control prior to final submittal.

. Ensured adherence to department guidelines, templates, SOPs, and

regulatory guidelines for all Medical Writing documents provided for

their therapeutic area.

. Participated in document timeline/resource planning within the

submission team.

. Ensured all documents met compliance with regulations, and that key

team messages were clearly represented.

. Reviewed study concepts and edited protocols for consistency,

progression, structure and grammar.

. Evaluated, interpreted and incorporated statistical analysis plans

into clinical study reports.

. Evaluated comments from reviewers of draft reports for appropriateness

and responded accordingly.

. Constantly (re)prioritized work to manage projects often requiring

multitasking skills.

. Participated in team and client meetings, project and time management

processes, marketing, and patient recruitment.

. Maintained time and events schedules in relation to protocol review

and development.

. Achieved project objectives while operating within challenging

timelines.

. Worked with medical writing management for strategic planning,

production & review of assigned summary documents.

. Coordinate with various technical professionals to gather, organize

and compile information on new products or processes.

. Created Ecollabora, a template documentation system based on ICH

guidelines to ensure proper format in all documentation.

World Wide Clinical Trials Austin, TX

7/2011 - 4/2012

MEDICAL WRITER (CONTRACT)

Managed the gathering and preparation of ICF, ISS/ISE clinical study

reports, for infectious disease, medical devices and oncology for PK

studies. Partnered in the preparation and review of study protocols, study

protocol synopses and amendments.

. Led the production of high quality documents in compliance with ICH

requirements and WCT SOPs; ensured consistency across documents and

improved overall document quality.

. Assisted with the preparation of study feasibility questionnaires and

related reports under the purview of Medical & Scientific Affairs.

. Good working knowledge of clinical study designs, common analysis

methods, descriptive and common inferential statistics, and data

presentation practices.

. Worked on multiple clinical studies simultaneously.

. Participate in team meetings and group discussions.

. Collect all regulatory documents for each study site.

. Practice and knowledge of GCP principles.

. Daily interactions with regulatory team and management.

. Good working knowledge of data management processes, including EDC

processes, documents and data flow in clinical trials

. Liaison with colleagues as appropriate to guide report content in

planning.

. Performed quality control and accuracy reviews and applied company's

editorial style.

. Data interpretation of statistical analysis.

. Advised and mentored colleagues and clients on medical writing-related

issues and procedures.

US Oncology The Woodlands, TX

5/2010 - 7/2011

REGULATORY/MEDICAL WRITER

Managed the collection of study-specific regulatory forms from clinical

phases I through IV from participating research sites. Partnered in

sponsor/CRO and FDA audits; provided training to sponsors/CRO on policies

and procedures.

. Prepared study-specific informed consents from an IRB approved

template; delivered protocols, amendments, ICF, advertising materials,

continuous reviews, and protocol deviations/exceptions to the IRB for

PK studies.

. Created and edited protocols and ICH/Summary reports.

. Protocol and SOP revisions.

. NDA Submissions (Modules 2&5)

. Manage completion and submissions of all documents.

. Participated in both group and moderately complex companywide process

improvement and development initiatives.

. Quality control and medical editing reviews on regulatory documents.

. Audit findings reporting.

. Coordinated with ethics committee in the rights, safety and wellbeing

of all trial subjects; ensured all unused trial supplies were

accounted for and closed down study centers at trial completion.

. Managed regulatory authority applications and approvals regarding the

research/marketing of new/existing drugs.

. Led the planning, coordination and ordering of clinical trial

materials.

. Set-up and monitored systems used by clinical research assistants to

ship CT materials to investigators, and maintained procedures to

account for and verify the expiration of CT materials.

. Organized investigator start-up and study-site initiation meetings.

Christus St. John Hospital Nassau Bay, TX

5/2007 - 5/2010

PATIENT ACCESS MANAGER

Managed complete financial outcome responsibility for all patient services,

while overseeing the facility operations of patient access functions.

Provided support, direction, and focus for the staff involved in all areas

of patient access.

. Led the staffing and management of daily activities to produce

successful outcomes.

. Conducted all aspects of EMR auditing and records management.

. Team motivation and implementation of new strategies.

. Utilized all statistical and financial reports as tools to analyze and

direct departmental operations.

. Obtained, recorded and ensured that all entered data was accurate and

included demographic, financial and compliance coding for each account

billed.

. Manage productivity and act as a liaison between physicians, families

and hospital staff.

. Utilized all statistical and financial reports as tools to analyze and

direct departmental operations.

. Maintain quality control programs, including reviews of denial

information as appropriate in the Patient Access Department.

. Project management, training of accurate registration processes and

team motivation.

. Orienting and providing in services and training, continuing

education, and development to all persons in the Patient Access

Department.

. Recommending space and other services needed by the Patient Access

Department

. Determines the qualifications and competence of the Patient Access

Department

. Verified insurance eligibility status and performed pre-

cert/authorizations.

. Calculated and collected co-payments at time of service; maintained

compliance with all hospital standards, directives, and regulatory

requirements.

. Adhere to policy and procedures and to make sure they are understood

by staff.

St. Joseph Hospital Houston, TX

1/2007 - 5/2008

PATIENT ACCESS REGISTRAR (PRN)

Interviewed, scheduled, registered, admitted and pre-admitted patients.

Assigned room/bed patient placements and in-house transfers, while

obtaining all applicable demographic and financial information.

. Verified insurance eligibility, performed pre-cert/authorizations, and

collects patient co-pays.

. Handled all aspects of psychiatric intake processing; performed EMR

auditing and records management functions.

. Clear and effective communication between the customer and the

registrar for accurate registration.

. Excellent verbal and written communication skills.

Gre-Mart New Orleans, LA 2/2006

- 1/2007

OFFICE COORDINATOR

Led the coordination of all office functions, to include the development of

HR manuals, forms and reports, administrative support efforts, and internal

communications.

. Partnered with payroll and HR to ensure efficient data communications

and the transfer of data between departments.

Primary Home Healthcare New Orleans, LA

3/2004 - 2/2006

STAFF RECRUITER

Conducted screening interviews with qualified, primarily exempt

professional candidates from the internal job posting system and from

external applicants. Created job postings and screened out non-qualifying

candidates.

EDUCATION

MASTER OF SCIENCE ~ HEALTH SERVICES ADMINISTRATION (2014)

Strayer University, Houston, TX

BACHELOR OF ARTS ~ LIBERAL ARTS (2009)

Texas Southern University, Houston, TX

Software Skills: Ecollabora (Personally created), Starting Point, Star,

Epic, CTMS, Medi-Tech, McKesson, PeopleSoft, ImageNow, Intralinks,

Microsoft Office Suite (Word, Works, Excel, PowerPoint, and Outlook)

PROFESSIONAL AFFILIATIONS

American Medical Writer's Association

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