SUMMARY OF QUALIFICATIONS
PhD medical writer with over 14 years of experience in drug development, including 4 years of direct medical writing experience.
- Experienced in writing regulatory documents, with a specialty in strategic documents such as briefing books, health authority responses, and designation requests.
- Drive completion of submissions with multifunctional international project teams by setting timelines, leading meetings, tracking all the necessary details, and addressing document needs.
- Lead writer for health authority question responses, briefing books, investigator brochures, clinical study reports (CSRs), clinical study protocols, breakthrough designation requests, clinical summary documents (eCTD modules 2.5 and 2.7), and more.
- Knowledgeable in multiple therapeutic areas, especially oncology, immunology, and gastroenterology.
Medical Writer and Consultant
- Lead authoring and review of documents to support regulatory submissions in collaboration with global client teams from multiple high-profile pharmaceutical clients.
- Provide internal training on biologics, statistics, and health authority responses.
- Develop plain language web content for health education.
- Led internal task force to create shareable content on topics of interest to the industry, tripling our LinkedIn following.
- Developed an Excel-based tool for project tracking.
- Responsible for analytical development of clinical drug substance and orally administered clinical supplies.
- Authored analytical specifications, stability protocols and reports, validation protocols and reports, method transfer protocols and reports, and CMC sections of IND/IMPD and IB.
- Co-developed global analytical training academy to roll out best practices and QbD principles across Novartis.
- Acted as change agent for global reorganization and retraining effort.
- Managed a team of 3 scientists.
- Performed analytical analysis to support clinical supply development of oral protein therapies.
- Developed scalable streamlined process for antibody-drug conjugation reaction and purification, developed “plug and play” lyophilized formulation for antibody platform.
- Authored GMP documents, including SOP, CoA, MSS, and batch records.
- Led project as co-PI for SBIR Phase I grant, supervised BS scientist.
Industrial pre-doctoral internship
- Screened inhibitor compounds against enzyme mutants to evaluate factors that influence drug potency.
Ph.D., Chemistry, University of Michigan, Ann Arbor
National Institutes of Health Chemical Biology Interface Training Grant Fellow
- Examined catalytic mechanism of metalloenzyme farnesyltransferase through transient kinetics and spectroscopy, investigating transition state and role of active site residues in the laboratory of Carol Fierke.
- Assisted with a grant proposal, writing research portions, and received funding from National Institutes of Health.
Graduate Student Instructor
- Taught Introduction to Biochemistry to 20 undergraduate students, leading discussion classes, writing quizzes, and grading assignments.
B.S., Chemistry with Honors, University of North Carolina, Chapel Hill
- Analyzed oxidative cleavage of 2′-substituted DNA by ruthenium compounds in the laboratory of H. Holden Thorp.
PROFESSIONAL AFFILIATIONS AND CERTIFICATES
American Medical Writers Association (AMWA) Essential Skills Certificate
AMWA Carolinas Chapter
- President-elect 2023-present
- Chapter conference committee 2020-present
- Interim webmaster Oct 2022-Mar 2023
- Social media coordinator 2019-2023
Pickett J. Augmenting medical writing with artificial intelligence and natural language generation. AMWA Journal. 2020;Spring:30-32. [Conference Report]
Pickett JS, Vakil R, Kuemmell A, McGill R, LoBrutto R. Circular dichroism: Applications to formulation development. PDU Journal (internal publication) 2011;1(1):1-7.
Pan C, Valente JJ, LoBrutto R, Pickett JS, Motto M. Combined application of high resolution and tandem mass spectrometers to characterize methionine oxidation in a parathyroid hormone formulation. J. Pharm. Sci. 2010;99(3):1169-1179. doi: 10.1002/jps.21901
Sapra P, Stein R, Pickett J, Qu Z, Govindan SV, Cardillo TM, Hansen HJ, Horak ID, Griffiths GL, Goldenberg DM. Anti-CD74 antibody-doxorubicin conjugate, IMMU-110, in a human myeloma xenograft and in monkeys. Clin. Cancer Res. 2005;11(14):5257-5264. doi: 10.1158/1078-0432.CCR-05-0204
Pickett JS, Bowers KE, Fierke CA. Mutagenesis studies of protein farnesyltransferase implicate aspartate beta 352 as a magnesium ligand. J. Biol. Chem. 2003;278(51):51243-51250. doi: 10.1074/jbc.M309226200
Pickett JS, Bowers KE, Hartman HL, Fu HW, Embry AC, Casey PJ, Fierke CA. Kinetic studies of protein farnesyltransferase mutants establish active substrate conformation. Biochemistry 2003;42(32):9741-9748. doi: 10.1021/bi0346852
Tobin DA, Pickett JS, Hartman HL, Fierke CA, Penner-Hahn JE. Structural characterization of the zinc site in protein farnesyltransferase. J. Am. Chem. Soc. 2003;125(33):9962-9969. doi: 10.1021/ja035927o
Chehade KA, Kiegiel K, Isaacs RJ, Pickett JS, Bowers KE, Fierke CA, Andres DA, Spielmann HP. Photoaffinity analogs of farnesyl pyrophosphate transferable by protein farnesyl transferase. J. Am. Chem. Soc. 2002;124(28):8206-8219. PMID: 12105898
Farrer BT, Pickett JS, Thorp HH. Hydride transfer in oxidation of nucleic acid sugars: electronic effects of 2′-substituents on activation of the 1′-C-H bond by oxoruthenium(IV). J. Am. Chem. Soc. 2000;122(4):549-553. doi: 10.1021/ja991967+
Pickett J. Power up your LinkedIn profile. AMWA Carolinas Chapter March 2023 Event, Virtual, Mar 21, 2023
Pickett J. Statistically speaking: How to avoid confusing or misleading your audience. Conference roundtable, AMWA Carolinas Chapter Conference, Virtual, May 6, 2022
Pickett J, Ellis Bogden M. Time to clock in: Applying manufacturing best practices to consistently and efficiently produce high-quality documents. Educational session, AMWA Medical Writing and Communication Conference, Virtual, Oct 29, 2021
Pickett J. Breaking into medical writing. Conference roundtable, AMWA Carolinas Chapter Conference, Virtual, May 7, 2021
Pickett J. The times they are a changin’: Managing change in every role. Conference roundtable, AMWA Medical Writing and Communication Conference, Virtual, Oct 20-22, 2020
Medical Writing and Regulatory Conferences
Pickett J, Bates K, DeSilver D. Cardiac safety studies from bench to bedside. AMWA Medical Writing and Communication Conference, Denver, CO, Nov 2, 2022
Bates K, DeSilver D, Pickett J. Demystifying clinical laboratory evaluations for effective presentation in clinical study reports. AMWA Medical Writing and Communication Conference, Virtual, Oct 27, 2021
Pickett J, Roy C, Whitsell R. Resources to guide drug and device development during the COVID-19 pandemic. RAPS Euro Convergence, Virtual, May 11, 2021
Sapra P, Griffiths G, Hayes M, Stein R, Pickett J, Govindan S, Sheerin A, Hansen H, Horak I, Goldenberg D. In vitro evaluation of a doxorubicin-antibody conjugate, on non-Hodgkin’s lymphoma and multiple myeloma cell lines. European Journal of Cancer Supplements, Volume 2, Issue 8, 2004, Page 93. · Nov 16, 2004
Sapra P, Stein R, Pickett J, Govindan SV, Cardillo TM, Damoci C, Sheerin A, Hansen HJ, Horak ID, Griffiths GL, Goldenberg DM. In vitro and in vivo targeting and therapy of an antibody-drug conjugate (IMMU-110) in B-cell malignancies. Blood 2004; 104 (11): 3287. · Nov 16, 2004
Sapra P, Griffiths G, Govindan S, Damoci C, Pickett J, Sheerin A, Cardillo T, Hansen H, Horak I, Goldenberg D. Pharmacokinetics and tissue biodistribution of a doxorubicin-antibody conjugate in mice. European Journal of Cancer Supplements, Volume 2, Issue 8, 2004, Page 89. · Nov 16, 2004
Griffiths GL, Sapra P, Pickett J, Cardillo T, Stein R, Govindan SV, Sheerin A, Damoci C, Horak ID, Goldenberg DM. Preclinical in vivo evaluation of a doxorubicin-antibody conjugate for treating multiple myeloma. European Journal of Cancer Supplements, Volume 2, Issue 8, 2004, Pages 91-92. · Nov 16, 2004
Novartis Internal Conferences
Pickett JS, Vakil R, Kuemmell A, Use of circular dichroism to investigate food effect for PTK796. (Analytical poster winner) Novartis 10th Annual Science and Technology Day (internal conference), East Hanover, NJ, May 19, 2011
Pickett J, LoBrutto R. Analytical QbD Academy. Novartis 10th Annual Science and Technology Day (internal conference), East Hanover, NJ, May 19, 2011
Pickett JS, Interdonato M, Muentener R, Marcella F, Agyilirah G, Teelucksingh J, Vrettos J, Jain P, Desai R. Quality culture in TRD: PHAD US, QA US, and Reg-CMC US. Novartis 10th Annual Science and Technology Day (internal conference), East Hanover, NJ, May 19, 2011
Pickett JS, Ghosh A, Valente J, Mulligan D, Singh R, LoBrutto R. Use of L-methionine to prevent solution-mediated oxidation of PTH134. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
Allenspach C, Valente J, Pickett JS. Incompatibility of ionic superdisintegrants and evaluation of a new excipient grade for PTH134. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
Allenspach C, Valente J, Pickett JS. LEAN formulation screening of PTH134 using the compaction simulator. (Formulation poster winner) Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
Valente J, Pan C, Allenspach C, Pickett, JS. Chemical reactivity between therapeutic peptides and an oral delivery agent. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
McGill R, LoBrutto R, Pickett JS, Valente J, Taneja V. APP018/APL018: Unraveling the mystery of analysis for non-covalent vs. covalent aggregates for proteins/peptides. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
Pan C, Valente J, LoBrutto R, Pickett JS, Motto, M. Combined application of high resolution and tandem mass spectrometers to characterize methionine oxidation in a parathyroid hormone formulation. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
Protano C, Valente J, Singh R, D’Altrui E, Erz K, Pickett JS. HPLC separation of low dose peptides from an excess of functional excipient. Novartis 8th Annual Science and Technology Day (internal conference), East Hanover, NJ, Feb. 24, 2009
External Scientific Conferences
Pickett JS, Bowers KE, Hartman HL, Fierke CA. Alternate binding modes important for catalysis in protein farnesyltransferase. Protein Lipidation, Signaling, and Binding Domains, FASEB SRC, Tucson, AZ, Jul 20-25, 2002
Pickett JS, Bowers KE, Scholten J, Fierke CA. Determinants of farnesyltransferase inhibitor potency. Midwest Enzyme Chemistry Conference (MECC); Chicago, IL, Sept 23, 2000
- Volunteered 3-5 times a week with 4th to 6th-grade robotics students at Triangle Math and Science Academy
- Introduced them to Lego Ev3 hardware components and programming
- Mentored them in their science project for FLL season
- 2017 season: taught the team about the impact of nutrient pollution on the water supply
- 2018 season: explored deep space travel, grew sprouts in Martian regolith
- 2019 season: interfaced with NC State Department of Geospatial Analytics to explore drones
- Organized and supervise field trips
- Provided support for First Lego League, line-follower, and sumo-bot tournaments
- Created a simple annual Thanksgiving drop-off food drive for my neighborhood.
- Collect and deliver food donations for the drive for Western Wake Crisis Ministry.
- As of 2022, the food drive has collected over 1815 pounds of food for those in need.
Coupon Book Sale Co-Chair
Salem Elementary School
- Coordinated distribution of 700 coupon books for fundraising.
- Designed and distributed paper and electronic marketing materials for the sale.
- Collected and recorded funds for deposit according to PTA guidelines.
- Organized recovery of unsold books.
- Raised over $8000 for PTA in 3 months.