Careers

LIFE AT GENPRO

Genpro is an organisation co-founded by a set of very experienced pharmaceutical professionals and funded with a vision to technologically augment the way clinical trials are conducted. We have offices in USA, UK and India and provide niche consulting services for the clinical research industry. We are just beginning our pursuits and have very fast and ambitious scale up plans. At Genpro, you will be compensated per the industry standards and will be provided with an excellent work life balance. You will also have the opportunity to work with some of the brightest minds of the world at Genpro.

Job Opportunities

Job summary:

Author and review regulatory & other medical writing deliverables independently as per high-quality standards (internal & external) and within expected timelines. Perform people and project management activities as assigned in support to business goals for the team and the organization. Support in building technical & functional expertise within the group by designing & executing robust training programs. Contribute/support other writers for manuscripts, slide sets, abstracts, posters, other techno-commercial documents as needed.

Key activities:

Authoring & reviewer of CSRs, Protocol, IB, Briefing books & other regulatory submission documents (including CTD modules) for US FDA, EMEA and rest of the world. Additionally, contribute to manuscripts, abstracts, posters, other techno-commercial documents as needed.
Author deliverables with scientific accuracy, based on facts from available sources, and meeting quality standards (including grammar and editorial requirements).
Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices.
Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
Conduct robust training programs for the team & support thought leadership activities in the domain.
Responsible for audit readiness of the department overall. Guide development of the SOPs, work instructions, and other documentation.
Support proactively in business expansion & department operation activities as needed.

Qualifications:

Education: PhD, PharmD, MPharm or MD

Experience:

At least 7-10 years of experience in Medical &/or Scientific writing. A mix of publication and regulatory writing will be a plus. Thorough understanding of industry standards and global trends. Highly proficient in MS Office products.

Work Location: Base Branch: Baroda, Gujarat. Remote / Work from home possible after initial induction for a deserving candidate with a proven track record.

Any questions? Reach out to MW.info@genproresearch.com

Job Summary:

To author and complete Medical Communications deliverables independently as per high quality standards (internal & external) and within expected timelines. Deliverables include manuscripts, slide sets, abstracts, posters, medical education materials, systematic reviews and other techno-commercial documents. Support regulatory medical writing deliverables like CSR, Protocols, IB etc.

Key activities:

Author original content for publications activities like primary/review manuscripts, abstracts, posters; slide decks etc based on specific inputs and sources supplied by customers.
Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
Follow all internal and/or client processes and adhere to GPP3 and other industry best practices.
Undertake quality control (QC, scientific reviews and/or proof reading of the above-mentioned deliverables.
Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
Conduct client/KOL interactions, kickoff meetings and teleconferences as needed covering various time zones in an effective manner.
Conduct thorough literature search and interpretations to support scientific advisory services.
Design and conduct robust training programs for the team.
Support in SOP, work-instructions and other documentation development and/or maintenance and keep the department audit ready at all the instances.
Support proactively in business expansion & department operation activities as needed.
Undertake additional tasks as assigned.

Required Skills / Experience

The candidate should be a Science graduate/equivalent
PhD, PharmD, MPharm or MD (desirable)
At least 5 years’ of experience in Scientific writing and communications either in Global pharma and/or service industry.
Mix of publication and regulatory writing will be a plus.
Thorough understanding of industry standards and global trends.
Highly proficient in MS Office products.

Work Location: Baroda, Gujarat. Remote work possible after one year for deserving candidate with proven track record.

Job Summary

The Quality Assurance (QA) Manager will be responsible for supporting and maintaining all aspects of the Quality System in accordance with the company’s quality manual, SOPs, and customer requirements. He / She will take on a management role in process definition or re-engineering for continuous improvement of operating procedures and processes. He / She will provide value-added, day-to-day support, guidance, and direction to the operational teams on matters of regulatory and process compliance in service of clinical trials. He / She will also be responsible for organizing, performing and supporting regular audits at assigned locations.

Key Activities:

Serves as key escalation and QA contact globally with focus on assigned/regional office locations.
Provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice.
Shared ownership in the development, implementation, and maintenance of Genpro’s Quality System, including facilitating process improvement activities for continuous improvement.
Ensures progress of related resources towards individual and departmental goals and initiatives and ensures the team’s qualifications remain current to defined standards.
Assists in definition, execution, and reporting of department objectives and assigned initiatives.
Proactive monitoring of compliance with Quality System reviews, Corrective and Preventive Actions, training, internal auditing, and supplier management.
Conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPS, GCP, 21 CFR Part 11, validation, and process improvement/problem solving.
Host customer audits as needed. Participate/support whenever required.
Perform internal audits to ensure that Quality Standards are being adhered to.
Assist in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
Participates in the evaluation of quality events, incidents and possible complaints or compliments and the follow-up events.
Keep up to date with all related quality legislation and compliance issues.
Represent the company during external inspections as required.
Perform Vendor Evaluation / Vendor audits as required.
Liaise with customers and suppliers where necessary (where impacting/affected by quality issues).
Empowered to make decisions without direct supervision.

Required Skills/ Experience:

Bachelor’s Degree in scientific field or equivalent with experience in any clinical research organisation.
1-2-year experience working within a regulated environment within depth familiarity with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc.
Excellent verbal and spoken communication skills
Prior regulatory inspection history strongly desired.
3 to 7 years’ experience in Quality Assurance role in a regulated environment or ISO 9000 certified company.
Prior management experience
Excellent knowledge of Risk Management, Risk Identification and Risked Based Testing. Identifying KPIs, KRIs and recording this on a proper basis
Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures.
Demonstrated expertise with computerized systems validation methodologies and related industry expectations.
Good working knowledge of industry regulations and their applicability to the work performed by Genpro.
Established client facing communication skills – ability to manage situations, negotiate conflicts, and influence others to achieve objectives.
Significant experience in hosting and/or conducting audits of computerized systems with clinical trial relevance.
Intermediate familiarity with computerized systems validation methodologies.
Strong problem solving/process improvement skills with ability to be part of and own solutions.
Ability to promote quality culture throughout Genpro’s business.

Work Location: Trivandrum / Cochin

About Genpro Research

Genpro is a biometric CRO headquartered in Waltham, MA with offshore offices in India. We help our clients to accelerate clinical research by applying AI, Machine Learning, NLP, Biostatistics, Medical Writing and Statistical Programming. Genpro brings together an experienced team of statisticians, statistical programmers, data managers, medical writers and clinical data scientists. Our team of experts drives innovation and foresight to deliver simple solutions to your most complex problems. We have expertise in Innovative designs including Adaptive and Bayesian designs. In addition, we drive time to market with cutting-edge software and data management solutions. We work with you as a strategic partner. Our team includes some of the most experienced and innovative professionals in the clinical research segment. We are excited to tell you about the value that we have collectively created. We are even more excited to drive success for you.

Job Summary:

The Senior Statistical Programmer will be responsible for providing statistical programming support for the Biostatistics and Data Management functions for all clinical trials and regulatory submissions. The incumbent will work closely with Biostatisticians and Data Managers to create SAS programs for independently validating selected tables, listings, and figures produced by programming vendors, for adhoc analyses, and to assist with data cleaning and query generation. This position will also serve as a contact for programming activities being performed at CROs.

Key Activities:

Perform data manipulation techniques and advanced techniques (arrays, transpositions, complex merges, SQL, SDTM etc.) and generic macro use and development to enable listing, table and graph generation.
Analyze information and develop innovative solutions to programming and data analysis challenges
Efficiently produce quality results under time constraints
Successfully coordinate multiple priorities
Complete assigned tasks within known budget constraints
Serve as the statistical programming lead on internal project teams and coordinate programming, verification, and documentation of statistical programs for use in creating analysis datasets, tables, listings, and figures
Assist internal project team in identifying project priorities and communicating such activities and associated timelines to departmental management
Work independently to carry out assignments with occasional support from senior management
Ensure the efficiency, quality, and integrity of data reporting and project activities executed
Represent the department in client meetings/presentation and maintain a positive working relationship with sponsors, collaborating associate and vendor personnel
Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
Contribute to on-going improvement of programming processes and methodology
Perform other related duties as required by the Department.

Required Skills / Experience:

Undergraduate degree or higher in Biostatistics, Computer Science, or related field
3-5 years of experience, or an equivalent combination of education or experience to successfully perform the key responsibilities of the job
Experience leading statistical programming activities in clinical research
Previous experience in a pharmaceutical research or CRO setting
Knowledge of one or more statistical software packages (SAS® preferred) used to conduct statistical analyses
Good verbal and written communication
Positive attitude and willingness to learn and contribute in a team setting
Demonstrates ability to successfully lead a single project

About Genpro Research

Job Summary:

The Business Development Manager (BDM) is responsible for the development and expansion of new business opportunities within established and prospective clients by providing leadership in overall business planning. BDM will manage the entire sales cycle from lead sourcing through contract closure. BDM will be responsible for making presentations to clients about our core product and service capabilities and will also respond to RFP’s, tenders, and identify opportunities in new geographies.

The Business Development Manager will liaise between clients and Genpro on all business development activities and requirements; will expand Genpro’s visibility, brand recognition, and professional credibility in the market and will assist with the development of marketing collaterals to promote Genpro.

Internally, the Business Development Manager works closely with Genpro executive team to establish key strategic partnerships with new and existing clients as well as with all functional teams within the company to enhance Genpro’s performance and client relations.

Key Activities:

Establish and maintain contact with pharmaceutical, biotechnology, CRO’s and Healthcare companies in order to gain knowledge of drug development programs, promote the Genpro’s products and services.
Generate and qualify new sales opportunities
Cultivate strong relationships with clients, from initial contact throughout the sales process. You will also ensure proper after-sales service including maintaining the business relationship.
Establish strong, long-term relationships with key decision-makers within accounts and develop deep knowledge of the client organization. Maintain high visibility within client organization. Monitor client satisfaction by communicating regularly with customer.
Analyze market opportunities; develop business plans and sales strategies for each account in liaison with subject matter experts. Monitor actions and results against plans.
Identify client needs in order to define sales opportunities. Ensure adequate solutions are proposed to client and lead opportunity management;
Creation of competitive study bid proposals and liaise with clients throughout the bidding process.
Liaise and attend meetings with client functions necessary to perform duties and aid business and organizational development.
Maintain high levels of repeat business through nurturing relationships with existing clients and ensuring service delivery satisfaction.
Promote Genpro with the specific purpose of expanding its market and increasing its client base.
Prepare and present Genpro’s core services and capabilities to customers
Attend and participate in professional meetings to promote the Genpro’s products and services.

Required Skills / Experience:

Bachelor’s Degree in a business, science, or related field.
Minimum of 2-5 years of experience selling services in CRO / pharmaceutical / biotechnology / life sciences industry.
Strong presentation skills (to prepare and deliver high-quality capabilities and sales presentations). Strong communication and interpersonal skills.
Experience with proposal development, contract negotiation and closing a contract. Ability to learn quickly and assimilate the detail of project requirements. Ability to be flexible and easily multitask. Good computer skills, including use of Microsoft Office suite (i.e., Word, Excel, Power point)
Work Location: Ahmedabad. Remote work from Bangalore/ Hyderabad

About Genpro Research

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