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James B. Lewin, PharmD

(617) 823-4152 lewinjim1@gmail.com 30 Parkside PL #215, Malden, MA 02148
RELEVANT PROFESSIONAL WORK EXPERIENCE
Jan 2014 Present

Biogen, Inc., Cambridge, MA

Manager, Medical Publications, Global Medical
(Global Publications Lead TECFIDERA)
Leading cross-functional publications committees to implement the medical
publication strategy in alignment with medical, commercial, and regional needs
Driving the execution of the publication plan; managing medical communications
vendors; managing the budget and developing semi-annual resourcing plans to
ensure optimal efficiency and balance between the internal scientific writers and
external agencies/writers
Identifying and engaging external Neurologists and MS experts as authors for
publications
Contributing to the overall Medical Strategy and post-approval data generation
plans, as well as co-leading data mining efforts in conjunction with Global
Biostatistics lead and Global Medical Directors
Providing ad hoc support as needed in reviewing relevant internal and external
documents for medical accuracy (eg, internal training documents, press releases)
Ensuring compliance with corporate and departmental policies and procedures,
regulatory bodies (eg, FDA and EMA), and external guidelines (eg, ICMJE, GPP2)

Jul 2012 Nov 2013

ARIAD Pharmaceuticals, Inc., Cambridge, MA

Medical Writer, Global Medical Communications
Worked with cross-functional, multidisciplinary teams to develop and implement
global publication plans
Coordinated the development of medical publications, along with managing the
review and submission process; also assisted in writing and reviewing clinical
sections of regulatory documents
Built and maintained relationships with internal and external stakeholders (key
opinion leaders, authors, investigators) and managed medical communications
vendors
Assisted in the development of a standard response letter repository for the global
medical information team, which helped to ensure the readiness of the medical
information call center upon approval of ARIADs first proprietary compound
Provided general support for other medical affairs activities including but not
limited to developing slide decks for advisory boards and investigator meetings;
conducting literature surveillance; training the field-based medical affairs team; and
competitive intelligence at scientific meetings

Jul 2011 Jun 2012

ISTA Pharmaceuticals, Inc., Irvine, CA

Postdoctoral Fellow, Medical Communications
Served as a medical reviewer on the Compliance Review Committee, which
included reviews of both medical and promotional materials
Provided timely and accurate medical information in response to unsolicited
requests from clinicians, payers, and consumers while maintaining fair balance and
high ethical standards, such as those outlined by the PhRMA code and the FDA

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Jul 2011 Jun 2012

Developed standard response letters and maintained the standard response letter
repository for all of the companys assets
Developed and reviewed abstracts, posters, and manuscripts; created slide decks for
advisory board committee meetings and for use by the field-based medical affairs
team
Assisted in developing and executing the publication plan for 2 of the company's
marketed products

West Virginia University School of Pharmacy, Morgantown, WV

Postdoctoral Fellow, Medical Communications
Provided adjunct faculty support to the Department of Pharmacy and the
Department of Pharmaceutical Systems and Policy
Conducted an independent research study related to Pharma-based Medical
Information and presented the results at a national conference

EDUCATION
Sep 2005 May 2011 Massachusetts College of Pharmacy and Health Sciences, Boston, MA
Doctor of Pharmacy, PharmD
PUBLICATIONS AND LECTURES
Nayak AS, Williams JI, Gow JA, Lewin JB, McNamara T.R. Bepotastine besilate ophthalmic solution 1.5%
significantly improves nasal itch in a randomized, double-masked, placebo-controlled, natural exposure clinical
trial of subjects with seasonal allergic rhinoconjunctivitis. Allergy and Asthma Proceedings. 2012;33(4):374.
Lewin JB, Muoz M, Madhavan SS. Assessment of pharmaceutical industry-based medical information
websites. Poster session presented at: the Drug Information Association (DIA) 23rd Annual Medical
Communications Workshop; 2012 March 5-7; Orlando, FL.
Lewin JB. Career opportunities for PharmDs in the pharmaceutical industry. Lecture presented to the Doctor of
Pharmacy class of 2013 at: West Virginia University School of Pharmacy; 2012 February 1; Morgantown, WV.
ADVANCED PHARMACY PRACTICE EXPERIENCE (APPE)
Feb 2011 Mar 2011

St. Elizabeths Medical Center, Brighton, MA

Preceptor: Salwa Elarabi, RPh

Jan 2011 Feb 2011

VA Boston Healthcare System, Brockton, MA

Preceptor: Dhiren K. Patel, PharmD

Sep 2010 Nov 2010

UMass Medical School - Commonwealth Medicine Clinical Pharmacy

Services, Shrewsbury, MA
Preceptors: Karen Lee, PharmD, BCPS and Pavel Lavitas, PharmD

Aug 2010 Sep 2010

K-Mart Pharmacy, Holyoke, MA

Preceptor: Thomas Wilusz, RPh

Jul 2010 Aug 2010

Brigham and Women's Hospital, Boston, MA

Preceptor: Andrea Resseguie, PharmD

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May 2010 Jul 2010

Rotated through the Multiple Sclerosis clinic, under the direction of Dr. Brandon
Brown; my primary responsibilities included counseling patients and managing their
therapy

VA Boston Healthcare System, Brockton, MA

Preceptor: Joe McNamara, RPh

PROFESSIONAL CERTIFICATIONS
Oct 2014 Present

Certified Medical Publications Professional (CMPP)

Certification Authority: International Society for Medical Publication Professionals
(ISMPP)
Certification number: 1875
Expiration: Dec 31, 2019

Aug 2011 Nov 2011 American Medical Writers Association (AMWA) Essential Skills Certificate
PROFESSIONAL MEMBERSHIPS
Dec 2012 Present
Sep 2012 Present
Mar 2012 Present
Nov 2011 Present
Aug 2011 Sep 2013
Sep 2010 Present
Nov 2009 Present

Industry Pharmacists Organization (IPhO)

International Society for Medical Publication Professionals (ISMPP)
*Member of the ISMPP Standards Committee since Apr 2013
The International Publication Professionals Association (TIPPA)
Drug Information Association (DIA)
American Medical Writers Association (AMWA)
American Society of Heath-System Pharmacists (ASHP)
American Pharmacists Association (APhA)

AWARDS AND HONORS

Medical Affairs Product Lead at ISTA Pharmaceuticals, Inc. (2011-2012)

Chosen as a motivational speaker for the Massachusetts Department of Children and Family Services
high school graduation banquet (2009-2010)
MCPHS scholarship and academic achievement award (2005-2011); Foster Care to Success Academic
Scholarship (2005-2011); MassMutual Foundation Academic Scholarship (2005-2009) and the Kiwanis
Club Scholarship (2005)
WRITING SAMPLES AND REFERENCES AVAILABLE UPON REQUEST