Susan M. Adamczyk, MS

Philadelphia, PA *****

adr7ac@r.postjobfree.com

267-***-****

SUMMARY

Senior/Principal Medical Writer: Global Medical Writing Manager Lead with over 30+ years of pharmaceutical experience and knowledge of ICH, FDA, IMPD, EMA (EU) guidelines.

Experience managing Medical Writers of various levels and on multiple projects (eg, CSRs, Protocols, PDSs, large SAE narrative projects) and from various countries (eg, US, India, and UK).

Published in multiple therapeutic areas working with various key opinion leaders.

Experienced in pharmacokinetic and pharmacodynamic clinical trials. Also have specialty in design of clinical trials for rare diseases.

Therapeutic areas of expertise include radionuclide oncology treatments, respiratory, type 2 diabetes/dyslipidemia, neurology/CNS, analgesia, cardiovascular, endocrinology, monoclonal antibodies, women’s studies, IBS, UC and dermatology: additional areas of knowledge include oncology/tumors, orthopedic, and orphan drugs.

Experience directing clinical documentation for pharmaceutical development, Phases 1 to 4, across many therapeutic areas for US and foreign submissions.

Author or QC reviewer of Phases 1 to 4 documents: CSRs, IMPDs, Regulatory responses, Safety narratives, ISSs, ISEs, protocols, IBs, FDA Fit-For-Purpose Responses, Briefing packages, CSSs, CSEs, IND updates, manuscripts, abstracts, posters, CME slide kits, and Guidance Documents.

Proficient in electronic template use, ie, StartingPoint and PleaseReview.

Developed and reviewed CRFs/eCRFs for study design and post-study evaluation.

Effective in participating in cross-functional global project teams.

Prior to working in drug development, worked for over 7 years as a Medical Case Manager, supervising treatment teams and presenting to neurosurgeons and other professionals regarding the treatment of patients with traumatic brain injury.

Developed CME initiatives (including extensive slide kits and monograph) with key opinion leaders, pharmaceutical companies, and prominent universities.

PHARMACEUTICAL INDUSTRY EXPERIENCE

Write On The Beach, LLC, Philadelphia, PA (additional information on page 2)

President/Company Owner, Contract Principal Medical Writer/Global Medical Lead Dec 2004 – Present [Primarily Remote]

Senior level regulatory writing projects including 2 Investigator Initiated Trials (IIT) Phase 2 protocol clinical trial study report (CSR) design and development, Section 14.3.3.1 SAE Narratives, 5 Phase 2 protocol CSR development, 3 Phase 3 CSR shells, Section 2.7.1 QC, Section 2.7.4 author, 3 Phase 3 protocols, 3 Phase 3 protocol amendments, Module 5 QC reviews, several Phase 2 and 3 protocol QC reviews, and FDA Briefing Books.

Medical communications projects including developing educational slide kits, writing annotations for primary review articles, and formulating questions for educational games used for Pharmaceutical Representative training: therapeutic areas included IBS, UC, and dermatology.

Examples of companies and projects worked for on a contractual basis:

Endocyte/Advanced Accelerator Applications (the radioligand business of Novartis) Principal Medical Writer/20-month contract [remote/with occasional onsite visits to IN] radioligand oncology therapy, specialty in prostate cancer.

Senior level regulatory writing projects including 2 Investigator Initiated Trials (IITs) Phase 2 including Section 14.3.3.1 SAE narratives for oncology clinical trial study reports (CSRs), design, development Phase 2 CSR shell, Phase 2 SAP shell, Phase 2 CSR for an IIT, QC review of Investigator Brochures (IBs), and summary documents.

Insmed Pharmaceuticals, Senior Medical Writer/6-month contract [Remote]

oWrote multinational Phase 2 protocol and Module 2.7.4 for rare diseases.

Cerami Worldwide Communications, Principal Medical Writer/9-month contract [Remote] IBS, UC.

oEducational slide kits for pharmaceutical representatives and medical doctors.

Symphogen Pharmaceuticals, Senior Medical Writer/6-month contract [Remote] oncology.

Allergan Pharmaceuticals, Principal Medical Writer/9-month contract [Remote] ophthalmology.

Wyeth Publications and External Communications Group Sr Medical Writer/18-month contract [Remote and weekly visits onsite in PA.]

oPrimary duties as lead or contributing writer for publication plans. Wrote abstracts, posters, and manuscripts from source documents/data for drugs in Phases 3 and 4: also, OTC products.

GlaxoSmithKline Clinical Pharmacology and Discovery Medicine Clinical Operations

Clinical Research Scientist/6-month contract [Remote and Onsite]

Primary duties focused on QC/reviewing data listings of study data for a challenging study requiring data reconciliation and site queries.

Wrote protocols, reviewed TLFs, and assisted in eCRF design/review.

Schering-Plough Global Medical Affairs Organization [Remote and Onsite]

Contract Senior Medical Writer/6-month contract

Wrote protocols and CTRs for the FDA and other international regulatory agencies.

Wrote IMPDs for the European Union.

Kinapse, New York, NY/United Kingdom July 2013 – Dec 2015 [Remote]

Global Medical Writing Lead/Manager March 2015 – Dec 2015 [Remote]

Managed a $2.6 million project and 5-10 Medical Writers: responsible for content consistency for a global pharmaceutical client’s multi-CSR, Phase 3 NDA initiative for a type 2 diabetes, monoclonal antibody, PCSK9 inhibitor. Lead content supervisor and responsible for the management of junior writers’ content.

--before promotion:

Principal Medical Writer (Regulatory emphasis) July 2013 – March 2015 [Remote]

Supervised a large number of Public Disclosure Synopses for a global pharmaceutical client that encompassed Phases 1 – 4 and OTC studies, in multiple therapeutic areas (eg, Womens’ studies, anti-infectives, rheumatoid arthritis [monoclonal antibodies], vaccines [pediatric and adult]).

Performed QC/QA slide kit reviews with reference annotations and primary author for CSRs for Phases 2 and 3 trials.

ReSearch Pharmaceutical Services, Inc, Fort Washington, PA [Primarily Remote]

Senior Medical Writer (Regulatory emphasis/some Medical Communications) July 2007 – May 2013

Served as lead or contributing writer for domestic and international regulatory documents for Phases 1 to 4, including: CSRs, protocols, IBs, ISSs, and ISEs: using ICH/AMA and clientspecific writing guidelines and templates.

Primary duties as lead or contributing writer for publication plans. Wrote abstracts, posters, and manuscripts from source documents/data for drugs in Phases 3 and 4: also, OTC products.

Served as lead QC reviewer for regulatory submission documents and training slide kits for global pharmaceutical clients.

Medical Education Systems, Inc, Philadelphia, PA [Remote and Onsite]

Senior Medical Editor 2001 – 2004

Lead writer for pharmaceutical programs with CME or promotional objectives.

Managed a $7.0 CME initiative with key opinion leaders in cardiology that focused on the writing and development of a comprehensive core curriculum resource kit (with over 250 slides with detailed speaker notes) for CME credits with emphasis in the areas of cardiology, endocrinology, dyslipidemia, and primary care: also included a 50-page AAFP-approved monograph on CV risk, with emphasis on dyslipidemia in special at-risk populations.

Developed promotional resource kits for endocrinologists and primary care physicians focusing on type 2 diabetes and the use of thiazolidinediones.

GlaxoSmithKline Pharmaceuticals, Philadelphia, PA [Onsite]

Clinical Research Scientist 1997 – 2001

Prepared final CTRs using company guidelines (including data interpretation and analyses, resolution of data queries, and clarification of issues pertaining to Quality Control).

Supervised conduct of clinical trials, Phases 1 to 4 (including various site and in-house training responsibilities, clinical monitoring, and auditing functions).

Participated in the development, initiation, and management of clinical pharmacology studies spanning Phases 1 to 4.

Covance Periapproval Services, Inc. Radnor, PA [Onsite]

Medical Writer and Senior CRA 1994 – 1997

Duties commensurate with positions as described above.

EDUCATION/PROFESSIONAL AFFILIATIONS

University of Scranton, MS Health Administration

University of the Sciences in Philadelphia Graduate level courses in Biomedical Writing

East Stroudsburg University, BS Biology concentration Laboratory Medicine

Member of the American Medical Writers’ Association since 1995

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