Megan Mitchell Withrow
Malvern,PA
Summary
Collaborative, detail-oriented, organized and driven Legal Professional with extensive legal and contracts experience in the pharmaceuticals, biotech, healthcare, and medical device industries. Deeply passionate about patient care, community, and advocacy.
Overview
9
9
years of professional experience
Work History
Manager, Legal Operations
Harmony Biosciences, LLC
Plymouth Meeting, PA
01.2025 - Current
- Lead legal reviewer for clinical trial agreements for two ongoing Phase III trials. Support Clinical Operations team with all other legal related queries or document reviews regarding ongoing trials and site activations and/or ICFs.
- Experience with GDPR and other related data privacy/data processing agreements.
- Support for all company contracts and training on company-wide contract policies and procedures, in addition to Conga contract software. Contracts are inclusive of non-disclosure agreements, statements of work, master services agreements, consulting agreements, work orders, amendments, termination letters, and change orders.
- Provide ad-hoc support to Promotional Review Committee and complete legal reviews/approvals in Veeva as required. Fully support and manage all Commercial contracts across Marketing, Market Access, Market Research, Sales Operations, and Commercial Operations teams.
- Maintain close-collaboration with other key departments such as Finance and Compliance.
- Assist with Board of Directors and intellectual property related filings and other matters.
- Complete contract lifecycle process end-to-end within the Conga system.
- Lead signature process via DocuSign and/or other signing method as required.
- Provide support to Business Development team with all data room document management.
- Work closely with C-Suite on escalated contract, budget, or data room matters.
Paralegal II & Contracts Manager
Marinus Pharmaceuticals, Inc.
Radnor, PA
03.2021 - 01.2025
- Support for three attorneys with a heavy workload in a fast-paced environment
- Responsibilities include support for the Board of Directors & committees, D&O questionnaire and Board Evaluation processes, Annual Shareholder meeting, Annual Proxy Statement
- Close collaboration with C-Suite, Finance, Compliance, Regulatory, Business Development, and Commercial teams
- Assigned quarter-close activities relative to SEC filings, contract reporting obligations, vendor and budget reconciliations
- Provide support for start-up of clinical trials, commercial product launch, and NDA regulatory filings
- Managed Marinus’ Irish subsidiary – Board of Directors meetings, annual return, all other corporate requirements
- Experience with state licensing renewals, drafting legal documents and/or memoranda, maintaining intellectual property portfolio
- Responsible for reviewing and updating company training materials and policies
- Managed and implemented Marinus’ contract management system software, Agiloft
- Reviewing, redlining, and negotiating various agreements (MSA’s, SOW’s, NDA’s, CDA’s, Clinical Trial Agreements, SaaS Agreements, Employment Agreements, HCP Agreements)
- Reviewing and updating Marinus contract templates, managing attorney review of contracts
- Promoted December 2021 and March 2023, received award for role played in supporting the company’s NDA regulatory filing for ZTALMY
- Member of Marinus’ Culture Committee (2021- present), Emerging Leaders Program (April 2023-November 2023)
Contracts Administrator
Globus Medical North America, Inc.
Audubon, PA
04.2019 - 03.2021
- Managed contract lifecycle for pricing, sale, purchase, hospital and GPO agreements for Mid-Atlantic region, Western Europe, and Australia
- Experience with RFI/RFP process, drafting contract templates, reviewing and redlining agreements, and managing attorney review for any escalations
- Coordinated signature process and filing in contract database
- Provided detailed summary reports to C-Suite as needed
- Served as main support and liaison for Finance, Sales, Pricing, and Legal teams
- Updated Globus contract templates as needed
Grants Coordinator
Globus Medical North America, Inc.
Audubon, PA
08.2017 - 01.2019
- Responsible for coordinating bi-weekly review of all charitable and educational grant requests
- Managed and organized tracker of all grant requests and scheduled review meetings with Grants Committee
- Worked closely with Compliance team on transparency reporting obligations
- Monitored budget and worked alongside Meetings & Event team for congress exhibits and other educational luncheon symposiums or sponsorships
- Coordinated bioskills labs with Sales team to support surgeons and residents on new training
- Experience with coordinating mission trips to Jamaica, Africa, and Nepal for medical missions
Education
Healthcare Law Specialization Certificate -
University of Pennsylvania
04.2020
Bachelor of Arts - English
Fordham University
Bronx, NY05.2017
Paralegal Certificate - undefined
Villanova University
Villanova, PA05.2019
Skills
- Microsoft Office Suite
- DocuSign, AdobeSign
- Contract Management Software (Agiloft, Contract Logix, Conga)
- Meetings & Events
- Board of Directors Management Software (Nasdaq, Diligent)
- Data room software (FirmEx)
- AI software: Microsoft CoPilot and Harvey
Timeline
Manager, Legal Operations
Harmony Biosciences, LLC
01.2025 - Current
Paralegal II & Contracts Manager
Marinus Pharmaceuticals, Inc.
03.2021 - 01.2025
Contracts Administrator
Globus Medical North America, Inc.
04.2019 - 03.2021
Grants Coordinator
Globus Medical North America, Inc.
08.2017 - 01.2019
Paralegal Certificate - undefined
Villanova University
Healthcare Law Specialization Certificate -
University of Pennsylvania
Bachelor of Arts - English
Fordham University