Manuel Gilberto Cabrera Lima

***** ****** ***. ****** ******, Tampa Fl., 33543

Tel: +1-813-***-****

e-mail: ad30i3@r.postjobfree.com

EMPLOYMENT HISTORY (Resume at Pharmaceutical Industry)

Mancet Corporación (Representative of Cum Laude for Venezuela)

Medical Advisor

Caracas Venezuela

February 2022 March 2023

Interact directly with client to coordinate all facets of projects.

Review and edit clinical development documents, including clinical study reports safety and efficacy summaries.

Review the papers and other documents to be used in the regulatory submission process of the products in the country.

Evaluation Analyze and interpretation of medical literature in order to select all those papers that can support Its use being the results statistically significant with absence of bias.

Review, correction and final approval of texts to be used in primary and secondary packaging. Review of texts of inserts of the product including composition, mechanism of action adverse effects, contraindications and other items required by the local health authorities.

Preparation of educational materials for training of the Sales Force, as well as elaboration, review of promotional materials of products of sale with medical prescription and advertisements for OTC products.

Bayer Venezuela

Caracas Venezuela

August 2006 / August 2016

Country Medical Director Bayer SA Venezuela

Organize the Medical Department Structure in Bayer SA Venezuela, previously all the support was done by Colombian Structure.

Planning the necessary structure of the department and presentation of needs to headquarters for approval, after the merger of both organizations(Bayer and Shering AG)

(medical advisors for each of the divisions and product groups, Pharmacovigilance Country Head, Clinical Trial Manager, Training manager and Field Trainers)

CV evaluation, interviews, selection, hiring and develop, the personnel of the Medical Department on the country organization: Medical Advisors (7), Medical Scientific Liaisons (4), Clinical Trials (1), Patients Support Program (1), Training Management (6), achieving the goal in 5 years according to business needs

To Leading the organizational process necessary for the medical structure in the country; implementing all of the activities that had been performed in the Medical Direction of Schering, and overseeing the correct execution on the part of the staff that were hired to fill the new position of the new organization.

I accomplished all the training scheduled by the Company (global, regional and/or local level), both face-to-face and/or remotely, including updates; since I started in the company including those which were assigned to be performed until the day of my departure from Bayer.

Created new relationships and reinforcing existing ones in all the new business structure, as a representative of the laboratory with the Associations and Societies, Medical-Scientific, Hospitals and Universities both national and international.

Code Compliance Officer: Ensuring medical governance and compliance with International Pharmaceutical Standards, BHC Standard Operating Procedures (SOPs), IFPMA Code of Pharmaceutical Marketing Practice, Local Code of Pharmaceutical Marketing, Local Laws and Regulations, local BHC SOP’s and other as applicable.

Official Medical spokesman of the Company. Reviewer and correction of press releases, key messages, voice in crisis; working together with Corporate Communications as facilitator in trainings; preparing spokespeople for medical, marketing and /or other issues related with the business- internal and external collaborators.

Develop and direct the Training Function in the organization, supervising the work of the persons responsible of the direct training (Training Manager, Training Coordinators and Field Trainers), ensuring the correct implementation of the coordination of activities to expand knowledge and promotional skill and competencies in the sales representatives, and marketing personnel to achieve the goals of the business units.

Develop and monitor the patient support program by hiring, training and supervision of the person hired within the company payroll as outsourced call center staff (call center and patients programs support) satisfy customer concerns, within ethical standards about Bayer s products either prescribed by the health care professionals or OTC products.

Manager with overall accountability for medical responsibility and Pharmacovigilance in Venezuela, encompassing all Bayer Pharma, and Consumer Care business.

Manager with Functional responsibility for Regulatory Affairs BHC in Venezuela (Functional supervisor of regulatory manager).

Supervisor of Ecuador and Peru Medical Departments by 2 years (R & F supervisor of Country Medical Directors 2014/2015)

Schering de Venezuela

Caracas

March 2002 August 2007 .

Medical Director at Schering de Venezuela

Evaluate the structure and processes of the Medical Department of Schering de Venezuela, on the basis of the standard operating Procedures of Schering AG, the legal regulations and the requirements of the company in Venezuela. I designed, developed, and implemented, the rules for the work of the MEDICAL DIRECTION, with the aim of orienting and monitoring (scientist knowledge), the ethical execution of the strategies of promotion and marketing of the products of the Laboratory.

Created new relationships and reinforcing existing ones, as a representative of the laboratory with the Associations and Societies, Medical-Scientific, Hospitals and Universities both national and international.

Design, executed and evaluated training programs and updating of knowledge, medical scientists, to the staff of the company and opinion leaders at the national level including check and approve training manuals with knowledge about normal function, disease, and products of the company for the employees.

Created local regulations for Schering de Venezuela S.A. (SVSA) about evaluation and approval of promotional material to be used and distributed by the laboratory, establishing the approval times, by shortening the period and achieving a higher scientist quality and support to all promotional material.

Act as Medical Advisor of Women Health Care Medical, and supervise of 2 medical advisor in other 2 areas(Dermatology and Oncology -Nexavar-)

Approver for all the medical information of marketing, before distribuion to thirth parts.

Act as Pharmacovigilance Country Head according to the global guidelines global and local regulations, including training all marketing and costumer service in the report of adverse events .Receive and reports the suspected adverse reactions of drugs, as well as response back to the physicians and/or patients involved.

Check periodically medical literature to identify articles related to the company's products and/or competitors, submitting it to the Products Managers performing necessary summaries to send to the sales in order to update them.

Implement with the product managers, training courses for opinion leaders, in areas related to speakers activity as: Effective presentations and public speaking, media handling, among others.

Design and develop the content of the scientific lectures, used by external key opinion leaders (not medical advisors) about the products of the company, achieving the uniformity in content and quality of the scientific and ethic message to the external customers.

I established close contact with the different national and international scientific societies, as well as universities and hospital departments, granting prizes to be delivered according to the criteria of these which have allowed us to create a strong image of the laboratory concerned by the education provider scientific.

Support directly and above Medical Advisors the Product Managers in the organization of medical scientific events both national and international, demonstrating the ethics and professionalism of the company in each of the events.

I designed and executed in collaboration with the Management of Human Resources the training program of the Sales representatives and Product Managers and First Line Managers in order to reach a better knowledge and professionalism.

Professional Activities previously to Pharmaceutical Industry

Ministerio de Sanidad y Asistencia Social

Barquisimeto

1999– 2001

Médico Jefe de Consulta de Planificación Familiar Hospital AMP

Descripción

.

Care activity in the areas of Gynecology and Planning of patients with special needs. Teaching activity for Pre and Post-Graduate students of Obstetrics and Gynecology in the areas of Family Planning in General, Laparoscopic Planning and Vasectomy.

Establishment of a cervical pathology service for patients of family planning clinics in Edo. Lara.

Development of management guidelines for patients with suspected cervical pathologies and altered cytology, detected in family planning consultations, avoiding an excess of patients in regular consultations.

Training of medical and paramedical staff attending consultations.

Support in the establishment of two cervical pathology services in two outpatient centers.

Establishment of the female endocrinology and menopause consultation of the family planning service, guaranteeing an informed and medically controlled transition for these patients.

Participation in the establishment of the outpatient male family planning (vasectomy) program.

Chief physician of the Pathology and Cervical Clinic HCUAMP.1986-1999.

Training undergraduate students in the use of basic tools for early diagnosis of cervical lesions, as well as in mass screening programs at urban and rural levels.

Universidad Centro Occidental Lisandro Alvarado Barquisimeto Venezuela

Profesor Contratado

Barquisimeto Venezuela

1986–1998.

Profesor de Ginecología (Clínica) de Pre y Post Grado

Descripción

Execution of the teaching programs established by the Lisandro Alvarado Centro Occidental University for the Undergraduate Obstetrics and Gynecology subject and the postgraduate Gynecology 1 and 2 subjects, achieving the fulfillment of the objectives in the groups under my charge.

Projection of instructional content based on existing programs, through the formulation of objectives, adapting them to each receptive group, sincerely achieving the objectives, adequately fulfilling the points of the program.

Design of dynamic theoretical-practical evaluations, in order to daily monitor the development of the course participants and personalize the instruction in each of them according to the personal care needs, thus achieving greater use of each participant at the end. the course. internship.

I took training courses on related topics such as evaluation techniques, formulation of objectives, instruction for adults, raising the level of knowledge and perfecting the work tools used daily.

Education and Certifications

Physician - Surgeon (1974 - 1980)

Universidad del Zulia (LUZ)

Maracaibo - Venezuela

Specialist in Obstetrician and Gynecology (1983 - 1986)

Universidad Centro Occidental Lisandro Alvarado (UCLA)

Barquisimeto - Venezuela

Master Orientación en Sexología (1972 – 1975)

Centro de Especialidaes Psiquiatricas, Psicologicas y Sexologicas de Venezuela

Barquisimeto Venezuela

Certified Professional Coder (December 2018)

American Academy of Professional Coding (AAPC)

Economic Self-Sufficiency Specialist Training (June 2019)

Sun Coast Region

Florida Department of Children and Families

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