CMC Project Manager Pharmica is looking for a CMC Project Manager for 6-month contract position. The CMC Project Manager will be responsible for providing project management support to teams responsible for management of pharmaceutical products and outsourcing partners. Primary responsibilities will include management of API (Active Pharmaceutical Ingredient) commercial teams supporting...

Position Summary Client’s Global Product Development organization is seeking an experienced organic chemist to drive preclinical / early-phase clinical development of small molecule drug substance processes. The Manager, Small Molecule Drug Substance will leverage deep expertise in organic chemistry to design safe, scalable synthetic routes suitable for delivery of gram to kilogram quantities...

Duties: Participate in study team meeting, align with study details and collaborate in meeting study objective, Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs. Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient...

Technical Writer Pharmica is seeking a driven and detailed Technical Writer for a 6 month contract. This position will be responsible for collaborating with other team members and support the project team. The Technical Writer position will be fully remote. Responsibilities will include, but not be limited to, the following: Write and update Module 3 (drug substance and drug product...

Project Manager Consultant – MES Delivers project management support and oversight for Manufacturing Execution System (MES) Projects, which involves the implementation of the MES system for electronic logbooks and all other projects as needed by the business.This includes the all work associated with the RFI and RFP processes, requirements definition, configuration, validation, cutover to...

Responsibilities -Serve as point person and system owner for ArcGIS -Work directly with clinical study teams, taking in their requests for mining and mapping patient data in order to help with protocol development, site selection, etc. -Create both standard geospatial patient mapping reports and handle ad hoc requests from study teams -Develop a long-term strategy for simplifying and...

CMC Project Manager Within the Process Development Group we are building a Global Business Operations Group. This group will have the following capabilities: Project Management, Portfolio Management, Change Management, and Risk Management. This position will focus on Project Management. At the moment we have several projects that are in flight and many more to come and only have one project...

Support Active management of the shared inbox Checking inbox 3-4 times per day Responding in a timely manner to all emails received from users in the mailbox Updating email subject to reflect true issue and status Proactively moving emails to the correct folder Forwarding emails containing technical issues to the IT Help email box Proactive management of support services with IT ...

HCP Service Provider Coordinator The consultant will be utilizing the HIP (Healthcare Interaction Portal) to support interactions with Healthcare Providers (HCP’s). HIP related activities include: HCP onboarding, approval, contracting, payment, training and special projects as required. This position reports into the HIP Operations Manager.This role will ensure compliance with applicable...

Summary Responsible for ensuring continuous product supply while minimizing EEO. Work with commercial/clinical teams and clinical supply managers to ensure alignment of drug substance and drug product demand and supply plans across Global Supply Chain for the Asset. Ensure metrics are in place to drive achievement of team objectives. Work with Asset Team to ensure processes are in place to...

Position Summary Manages the efficient flow of goods, services, and information throughout the clinical supply chain, including product order management and global distribution. Builds relationships with and acts as a key resource and escalation point for internal customers, distributors, and suppliers. Contributes to the creation of strategy for clinical drug supply; translates strategic...

Project Management responsibilities will include; Project coordination and management of strategy work-streams and business development opportunities, activities include but are not limited to: 1. Interact with external parties to arrange for introductory demo’s, capabilities, presentations, and Q&A 2. Develop and execute project plans for complex strategy and business development projects 3...

JOB SUMMARY This position will drive enhancement of the Global Quality function by working closely with the Global Project team on various initiatives and workstreams. A dynamic role, the ideal candidate will be flexible and adept at multitasking. As priorities shift, the candidate should be comfortable performing a wide variety of tasks daily, quickly able to adjust their strategies to match...

In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Coaches members of a work team and ensures adherence to established guidelines. Provide input to program budget and timelines to ensure successful management of all aspects of international clinical...

Duties: - Receive and process requests within the company eDMS for controlled document creation, changes, or withdrawal (Document Control, Change Requests). - Maintain tracking and processing of controlled documents relating to company Periodic Review process. - Maintain the system for records and retention using a standard categorization system in accordance with internal and regulatory...

PV Project Manager The PV Project Manager will work on the Pharmacovigilance team and support the team on projects. The successful candidate will be comfortable facilitating meetings, taking minutes, and following up on action items. Job requirements: · Provide leadership support for Global PV Leadership Teams · Finance and budgeting for PV · Other Global PV Initiatives as needed ·...

Technical Writer Quality Record Management - AGILE System   Demonstrates strong knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks. Can work under tight deadlines while delivering a high-quality output. Demonstrates analytical problem-solving skills. Demonstrates ability to explain complex...

Assists the development and implementations of robust global sourcing strategies for marketing and sales goods and services that link to core business deliverables while leveraging knowledge of the marketplace and supplier community. Takes a holistic view of spend and identifies category level demand management, leverage, and LCC opportunities. Contributes to defining and modifying the...

Job Description The Drug Development Project Manager acts as a central contact for information on a particular program and manages activities to develop programs. Ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. Works with management staff and teams to create the development strategy, establish objectives,...

IT Project Manager Duties: Develop and manage detailed project plans inclusive of key milestones, critical path tasks, deliverables, and resource allocation Continually identify, prioritize, and mitigate risks of the program based on a balanced approach of best practice for Identity Access Management (IAM) solutioning, criticality of the requirements, and the impact to the key outcomes ...

Experience Partner with the business to understand SharePoint sites and what needs to be migrated Work with business to move custom sites to out-of-the-box sites in SharePoint. Develop solutions to satisfy requirements and articulate to the business Lead junior SharePoint Migration consultants on what to do pre-migration and review sites post migration Develop SharePoint sites as needed ...

Experience Work with business to move custom sites to out-of-the-box sites in SharePoint. Develop solutions to satisfy requirements for the business Collaborate with senior SharePoint Migration consultants on what to do pre-migration and review sites post migration Develop SharePoint sites Provide training as needed Qualifications Migration experience is very helpful at least 2 years...

Job Description The Drug Development Project Manager acts as a central contact for information on a particular program and manages activities to develop programs. Ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. Works with management staff and teams to create the development strategy, establish objectives,...