MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH

MAPP 4655.3 Rev 3

POLICY AND PROCEDURES
OFFICE OF MANAGEMENT
Procedures for CDER Medical Officer Conversion to Career-Conditional

Table of Contents
PURPOSE ..............................................................................1
BACKGROUND ...................................................................1
POLICY .................................................................................2RESPONSIBILITIES ...........................................................2
PROCEDURES .....................................................................4
REFERENCES ......................................................................5
DEFINITIONS ......................................................................5
EFFECTIVE DATE ..............................................................6
CHANGE CONTROL TABLE ............................................6
ATTACHMENT A – Training Log .....................................7
ATTACHMENT B -- Sample Memorandum of
Recommendation for Conversion.......................................10
ATTACHMENT C -- Checklist for Submitting a Level
2 Conversion Package ........................................................11

PURPOSEThis MAPP describes the policies and procedures for qualification and application for
medical officers in the Center for Drug Evaluation and Research (CDER) to convert
from level 1, associate reviewer, to level 2, reviewer. This MAPP also includes thegeneral expectations for formal training and work assignments to be completed by the
medical officer during the first years of employment for successful conversion fromthe temporary appointment of level 1, associate reviewer, to the career conditional
appointment of level 2, reviewer.

BACKGROUND•

CDER hires medical officers on temporary appointments because distinct
differences exist between the work required by a CDER medical officer and thetraining and experience of many physicians before coming to CDER. Although a
medical officer’s clinical training, experience, and expertise are key components

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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to be a successful reviewer, due to the uniqueness of the clinical review process,most new reviewers require additional experience and training. Although theextent of this varies depending on the new reviewer’s previous training andexperience, in general the initial years of work at CDER are considered to be theequivalent of a fellowship in drug development and drug regulation.
•

A medical officer is considered a candidate for conversion to career conditional
appointment when he or she has successfully completed the formal training
requirements outlined in this MAPP and the work accomplishments as establishedby the team leader/supervisor.

POLICY•No time requirement is imposed for conversion from a Level 1 associate reviewer
to a level 2 reviewer. Conversion to level 2 is achieved by meeting the defined
criteria set forth in this MAPP. Generally, a reviewer should be able to movefrom level 1 to level 2 within 2-3 years. Work performance and work products
will be reviewed for accuracy, completeness, and overall quality and factored inwhen considering a candidate’s eligibility for conversion.

•

Supervisors remain responsible for the performance evaluation of reviewers.
Performance evaluations should rate individual reviewers at their existing level,
not at a level they are working to achieve.

RESPONSIBILITIESThe Candidate will:•

At the request of the team leader/supervisor, meet with their team leader,supervisor, and division director to discuss expected training and work
assignments.

•

If applicable, initiate discussions requesting course credit in lieu of courseworkwith the team leader and, if advised, prepare a memorandum of request for review
by the supervisor.

•

Meet with the team leader, supervisor, and division director to discuss
requirements and eligibility for conversion to level 2.

•

Prepare a written summary of accomplishments in support of conversion to level
2 for team leader/supervisor review.

•

Provide a complete conversion package (with cover sheet and checklist (Attachment C))
to the team leader and/or supervisor.

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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The Team Leader and/or Supervisor of the Candidate will:•

Meet with the candidate for frank and open discussions of the candidate’s training
and assignment scheduling.

•

Clearly communicate to the candidate his or her progress and map out required
work accomplishments to qualify for conversion.

•

If applicable, the team leader will make an initial assessment regarding credit inlieu of coursework, and following a discussion with the candidate make the final
approval or disapproval decision on the written request.

•

Maintain documentation of candidate’s work and assignments to be used insupport of conversion, including material that documents that the candidate
applies and follows appropriate policies, laws, and regulations in completion of
his or her work, follows appropriate guidances and MAPPs in completing
assignments (e.g., the safety review guidance, the Clinical Review Template), andthat the work product is generally accepted as complete and adequate by his or her
team leader/supervisor without need for extensive revisions or corrections.

•

Meet with the candidate and division director to review the candidate’s summaryof accomplishments and Training Log to assess the candidate’s eligibility forconversion.

•Communicate to the candidate whether to proceed with preparation of theconversion package.

•

Provide guidance in preparing and review of the candidate’s conversion package.

•

Forward recommendations for conversion to the division director.

•

Conduct regularly scheduled performance evaluations.

The Division Director will:•

Meet with the candidate, team leader, and/or supervisor to review the candidate’ssummary of accomplishments and Training Log, and make recommendation as towhether the candidate should proceed with the conversion package.

•

Review the conversion package for accuracy and completeness and ensure that it
fully demonstrates the candidate’s qualification for conversion.

•

If applicable, write a memorandum recommending conversion and forward withthe conversion package to the office director.

•

Meet with the office director to discuss the candidate’s eligibility and review theirconversion package.

•If applicable, initiate personnel action for conversion once the package is returned
with the office director’s concurrence.

•

Notify the candidate of the decision.

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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The Office Director will:•

Meet with the division director to discuss the candidate’s eligibility and review
the conversion package.

•

Check the conversion package for accuracy and completeness and ensure that itdemonstrates the candidate’s qualification for conversion.

•

If a waiver or credit in lieu of coursework is requested, the office director will be
the final approving official.

•

Sign the conversion recommendation memorandum as either approved or
disapproved and return to the division director. If disapproved, detail in writing
why the candidate is not qualified at this time and what steps are needed for the
candidate to qualify.

PROCEDURES

1. Once required training requirements and work assignments have been met, thecandidate, team leader, supervisor, and division director will discuss level 2
qualifications and reach verbal agreement that the candidate is eligible forconversion.
2. The candidate will maintain a summary of accomplishments and a Training Log(Attachment A) to be used in support of conversion and forward to the teamleader and/or supervisor for consideration.
3. If applicable, credit in lieu of coursework will be determined by the following:a. The candidate will initiate discussions with their team leader to evaluateprior experience, previous course work, or on-the-job training to beconsidered for credit in lieu of coursework. The candidate must be able todemonstrate both alternative training and mastery of the specific course
content.
b. The team leader will assess the verbal request for credit in lieu ofcoursework and advise the candidate to submit a memorandum of request
to the supervisor if applicable.
c. The candidate will prepare the memorandum providing a thoroughjustification requesting credit in lieu of coursework and route thememorandum through the team leader to the supervisor.
d. The supervisor will review the memorandum requesting credit in lieu ofcoursework and approve or disapprove as appropriate. If the request isdisapproved then the supervisor will meet with the team leader andcandidate to explain the decision.
e. Approved credit in lieu of coursework will be noted on the Training Log(Attachment A) by the candidate and the signed memorandum(s) will be
submitted as part of the final conversion package.
4. The team leader and/or supervisor will forward the recommendation forconversion, the Training Log, and the conversion package to the division director
for consideration.
Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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5. The division director will review all documentation, sign concurrence of therecommendation memorandum as appropriate, and forward to the office director.
6. The office director will meet with the division director, discuss the candidate’squalifications, and review the conversion package.
7. The office director will sign the recommendation memorandum as appropriate
either approved or disapproved. If disapproved, the office director will outline thereasons for disapproval in writing and the necessary steps to complete thequalification process. The office director will return the memorandum andconversion package to the division director.
8. If approved, the division director initiates the personnel action for conversion andnotifies the candidate.
REFERENCES

1. FDA, Staff Manual Guide 3120.1, FDA Training and Staff Development Policy.
2. CDER, Office of Executive Programs, Division of Learning and Organizational
Development (inside.FDA).
3. CDER, Office of Executive Programs, Division of Learning and Organizational
Development, Catalog & Programs (inside.FDA).
4. CDER, Office of Executive Programs, Division of Learning and Organizational
Development, CDER Competencies, Position- Specific Competencies, Office of
New Drugs, OND Clinical Reviewer (inside.FDA).
5. CDER, Office of Executive Programs, Division of Learning and Organizational
Development, Catalog & Programs, New Reviewers Blended Learning Program(inside.FDA).

DEFINITIONS•Conversion Package. The conversion package is the description andexamples of a candidate’s knowledge, skills, and abilities that demonstratesatisfactory completion of the qualification guidelines for a level 2 reviewer.
The package includes:
1) Written summary of the candidate’s accomplishments
2) Candidate’s completed Training Log (Attachment A)3) Approved memorandums for credit in lieu of coursework (if applicable)
4) Conversion memorandum from the division director to the officedirector recommending the candidate for conversion (Attachment B is asample)•Level 1 Associate Reviewer. A new reviewer, generally on his or her first
appointment with CDER. Associate reviewers work with their team leadersand mentors (if applicable) to learn the review process and actively pursue thescientific/regulatory knowledge necessary to work at the full performance

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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MAPP 4655.3 Rev 3level. Typically, an associate reviewer’s position is at the general schedule(GS) grade 14 level.
•

Level 2 Reviewer. A reviewer who has acquired general knowledge of thereview process and successfully completed the individual development plan inaccordance with this MAPP to meet the core competency level for his or her
discipline. A level 2 reviewer understands the basic tools of regulatory drug
review and is capable of producing good reviews with some supervisory
guidance. He or she functions as a team player and cooperates with others
involved in the drug review process. Typically, a level 2 reviewer’s positionis at the general schedule (GS) grade 14 level.

•

Training Log. A checklist of all required coursework to be filled in by thecandidate, including dates when the courses are successfully completed(Attachment A).

EFFECTIVE DATEThis MAPP is effective upon date of publication.

CHANGE CONTROL TABLE

Effective
Date
11/24/10

Revision
NumberN/A

Revisions

5/14/151

7/11/162

9/6/17

3

Attachment A (Training Log) was revised to show recent changes incourses. Formatting changes were made to the document.
Attachment A (Training Log) was revised to show recent changes incourses. Reference and formatting changes were made to the
document.
Attachment A (Training Log) was revised to show recent changes incourses. Reference and formatting changes were made to the
document.

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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MAPP 4655.3 Rev 2

Training Log – Internal Courses
Medical Officer, Level 1, Associate Reviewer
All listed training is conducted through the CDER and CDER Offices. Every effort should be madeto complete the individual courses in the time frames indicated, which are based on your start date.
Variance in scheduling should be done only with advance approval from your team leader and/or
supervisor. Coursework can be completed in person (preferred) or through online resources
as appropriate, with prior concurrence from the medical officer’s team leader or supervisor.
The completed log should be submitted as part of the conversion package to level 2, reviewer.
Upon completion of each course, the course dates should be entered in the space before thecourse name.
The following courses and timeframes, in general, should be completed within the first 2 years.
In some cases, credit in lieu of coursework may be approved by the Division Director whena candidate can demonstrate both prior training or experience and mastery of the specificcourse material. The policies and procedures for requesting credit in lieu of coursework areprovided in this MAPP.
*In addition, some courses listed below are more appropriate for the activities of specificorganizations and are designated to be taken “as appropriate”.
Software courses are recommended for the development of data analysis and computer skills andcompetencies. Courses are available through OIM, OBI, OCS, OTS and OND as noted. Someare available through the FDA OIM Training Center for a fee ($150) paid by the participant’s
division.

Links to Training Registration pages:
CDER Training Calendar & Schedule (Fall, Winter and Spring semesters)
OND Learning Calendar (Year-round, live and recorded)
OTS Training Page (Fall and Spring semesters)
OCS Training Page (Year-round, live and recorded)
OBI Training (Year-round)
FDA Library (Year-round)
OIMT Training Page (Year-round)Updated April 2018

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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D
ATE
COMP
LETED

MAPP 4655.3 Rev 2

Required CDER Medical Officer Updated Course List
(with proposed scheduling)
0-6 Months
CDER New Employee Orientation (Day One)
CDER Equal Voice Training
http://inside.fda.gov:9003/cder/officeofthecenterdirector/ucm261351.htm
CDER New Reviewer Learning Program (online)
CDER IND Learning Program (online)
OND Introduction to Clinical Review
OND Clinical Reviewer Handbook (print resource)
http://inside.fda.gov:9003/downloads/CDER/OfficeofNewDrugs/ImmediateOffice/ONDLearn
ingandCareerDevelopment/UCM554121.pdf
CDER Introduction to Design and Conduct of Clinical Trials
CDER Technical Writing -OR- OND Technical Writing for Reviewers
OBI DARRTS Training (multiple modules)
OBI eCTD Viewer (GlobalSubmit Review) Training
FDA Library BMIS, Bioresearch Monitoring Information System

Optional/As
NeededOptional/As
NeededOptional/As
NeededOIMT MS Outlook Introduction
OIMT MS Word Introduction
OIMT MS PowerPoint Introduction

6-9 Months

CDER NDA/BLA Regs and Policies (classroom or online)
CDER Review of Clinical Trials
OND Ready, Set, Review
OND 2017 Clinical Review Template Introduction
OND The Road to Assessing Benefit and Risk
CDER MaPP 6010.3 Clinical Review Template Attachment B (Safety Review, p. 36 – print
resource)
http://inside.fda.gov:9003/downloads/aboutfda/centersoffices/officeofmedicalproductsandt
obacco/cder/manualofpoliciesprocedures/ucm080121.pdf
CDER Learn the Safety DanceOTS MedDRA Training – I & II
OCS Data standards training
OCS JMP and JMP Clinical Training (multiple modules)
FDA Library Electronic Resources
FDA Library Training: Introduction to PubMed/EBSCO Host/Research Tool
Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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MAPP 4655.3 Rev 2

Required CDER Medical Officer Updated Course List
(with proposed scheduling)
9-12 Months

CDER Topics in Clinical Trials

CDER Basic Statistical Methods
CDER Negotiating with Confidence
CDER Epidemiology in Drug Safety (classroom or online)
CDER Presentations Skills: Speaking to Inform and Persuade
CDER or OND Career Development and Individual Development Planning
Communication or Interpersonal Skills courses (8-12 hours suggested)
Optional/As Needed

OIMT MS Outlook Intermediate

Optional/As Needed

OIMT MS Word Intermediate

Optional/As Needed

OIMT MS PowerPoint Intermediate

Optional/As Needed

OIMT MS Excel Introduction

12-24 months

CDER Basic Drug Law

CDER Principles of Generic Drug Regulation and Review (in development)
CDER Chemistry for the Non-chemist (classroom or online)
CDER Toxicology for Non-toxicologists (online)
Optional

OCS MAED Training (multiple modules – Live and Online)

Optional

OCS JReview Training (multiple modules – Live and Online)

Optional/As Needed

OIMT MS Excel Intermediate

Optional/As Needed

OIMT MS Word Advanced

Complete a broad portfolio of review assignments appropriate to the medical officer’s role andOffice. As an example, the list should include most, if not all of the following for typical review
assignments:_______Review of new commercial and research INDs_______Review of phase 2/3 protocols_______Review of a SPA for a clinical protocol_______Review of IND annual reports_______Review of an original NDA/BLA and/or a major efficacy supplement_______Review of NDA/BLA annual reports, involvement in assessment of postmarketing
safety issues_______Participation in an advisory committee meeting related to review
of a NDA/BLA application_______Representation of his or her discipline at appropriate meetings with sponsor

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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ATTACHMENT B -- Sample Memorandum of Recommendation for Conversion
Center for Drug Evaluation and Research

To:

Food and Drug Administration_, M.D.
Director, Office ofFrom:, M.D.
Director, Division of

Date:
Subject:

Recommendation for Conversion to Level 2, Reviewer.

This memorandum is to recommend and to justify the conversion of Dr.
from the medical officer temporary appointment of level 1, associatereviewer, to the career conditional appointment of level 2, reviewer.
The initial recommendation for conversion was made by his or her supervisor (or teamleader if director is the only supervisor)on(date).
Dr.

joined the division on.

Dr.
has successfully completed all criteria necessary to beconsidered for this conversion as evidenced by the documentation in the conversion package
which includes: summary of activities, training log, review examples, and most recent PMAP ofrecord reflecting a rating of at least “Fully Successful” dated.
It is my pleasure to recommend Dr.
converted to the career conditional, level 2, reviewer.

to you for consideration to be_, M.D.
Director, Division ofCC:
Supervisor
Team Leader
Management Officer
Program Specialist
Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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file

Originating Office: Office of Management
Effective Date:, 7/11/16, 9/6/17, 4/25/18

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ATTACHMENT C -- Checklist for Submitting a Level 2 Conversion Package

COMPONENTS OF THE CONVERSION PACKAGE:
Summary of accomplishments
Training log (Attachment A)
Approved memorandum(s) for credit of in lieu of coursework (if applicable)
Conversion memorandum providing recommendation for conversion from thedivision director to the office director (Attachment B is a sample)

Originating Office: Office of Management
Effective Date: 11/24/10; 05/12/15, 7/11/16, 9/6/17

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